An integrated FoodNet in North East India: fostering one health approach to fortify public health.

BACKGROUND: Food safety is a critical factor in promoting public health and nutrition, especially in developing countries like India, which experience several foodborne disease outbreaks, often with multidrug-resistant pathogens. Therefore, implementing regular surveillance of enteric pathogens in the human-animal-environment interface is necessary to reduce the disease burden in the country. OBJECTIVE: To establish a network of laboratories for the identification of major food and waterborne pathogens prevailing in the northeast region of India through integrated surveillance of animal, food, human, and environment and investigate the antimicrobial susceptibility pattern of the pathogens of public health significance. METHODS: The Indian Council of Medical Research (ICMR) has identified FoodNet laboratories; based on their geographical location, inclination to undertake the study, preparedness, proficiency, and adherence to quality assurance procedures, through an 8-step process to systematically expand to cover the Northeastern Region (NER) with comprehensive diagnostic capacities for foodborne pathogens and diarrhea outbreak investigations. Network initiated in the NER given the unique food habits of the ethnic population. FINDINGS: This surveillance network for foodborne enteric pathogens was established in Assam, Arunachal Pradesh, Tripura, and Sikkim, and expanded to other four states, i.e., Manipur, Mizoram, Meghalaya, and Nagaland, thereby covering the entire NER by including nine medical and three veterinary centers. All these centers are strengthened with periodic training, technical support, funding, capacity building, quality assurance, monitoring, centralized digital data management, and website development. RESULTS: The ICMR-FoodNet will generate NER-specific data with close to real-time reporting of foodborne disease and outbreaks, and facilitate the updating of food safety management protocols, policy reforms, and public health outbreak response. During 2020-2023, 13,981 food samples were tested and the detection of enteric pathogens ranged from 3 to 4%. In clinical samples, the detection rate of the pathogens was high in the diarrheal stools (8.9%) when 3,107 samples were tested. Thirteen outbreaks were investigated during the study period. CONCLUSION: Foodborne diseases and outbreaks are a neglected subject. Given the frequent outbreaks leading to the deaths of children, it is crucial to generate robust data through well-established surveillance networks so that a strong food safety policy can be developed for better public health.

Impact of Early Microparticle Release during Isolated Severe Traumatic Brain Injury: Correlation with Coagulopathy and Mortality.

BACKGROUND: Microparticles (MPs) have been implicated in thrombosis and endothelial dysfunction. Their involvement in early coagulopathy and in worsening of outcomes in isolated severe traumatic brain injury (sTBI) patients remains ill defined. OBJECTIVE: We sought to quantify the circulatory MP subtypes derived from platelets (PMPs; CD42), endothelial cells (EMPs; CD62E), and those bearing tissue factor (TFMP; CD142) and analyze their correlation with early coagulopathy, thrombin generation, and in-hospital mortality. MATERIALS AND METHODS: Prospective screening of sTBI patients was done. Blood samples were collected before blood and fluid transfusion. MP enumeration and characterization were performed using flow cytometry, and thrombin-antithrombin complex (TAT) levels were determined using enzyme-linked immunosorbent assay (ELISA). Circulating levels of procoagulant MPs were compared between isolated sTBI patients and age- and gender-matched healthy controls (HC). Patients were stratified according to their PMP, EMP, and TFMP levels, respectively (high ≥HC median and low < HC median). RESULTS: Isolated sTBI resulted in an increased generation of PMPs (456.6 [228-919] vs. 249.1 [198.9-404.5]; P = 0.01) and EMPs (301.5 [118.8-586.7] vs. 140.9 [124.9-286]; P = 0.09) compared to HCs. Also, 5.3% of MPs expressed TF (380 [301-710]) in HCs, compared to 6.6% MPs (484 [159-484]; P = 0.87) in isolated sTBI patients. Early TBI-associated coagulopathy (TBI-AC) was seen in 50 (41.6%) patients. PMP (380 [139-779] vs. 523.9 [334-927]; P = 0.19) and EMP (242 [86-483] vs. 344 [168-605]; P = 0.81) counts were low in patients with TBI-AC, compared to patients without TBI-AC. CONCLUSION: Our results suggest that enhanced cellular activation and procoagulant MP generation are predominant after isolated sTBI. TBI-AC was associated with low plasma PMPs count compared to the count in patients without TBI-AC. Low PMPs may be involved with the development of TBI-AC.

Comprehending the risk of foodborne and waterborne disease outbreaks: Current situation and control measures with Special reference to the Indian Scenario.

Background: Foodborne and waterborne diseases and outbreaks are a neglected public health issue worldwide. In developing countries, diarrheal disease caused by foodborne and waterborne infections is a major cause of ill health. There is a lack of information on foodborne pathogens, their transmission routes, outbreaks, and related mortalities, due to the absence of a robust disease surveillance system and adequately equipped laboratories. Although hygiene practices are much better in Western countries, the widespread use of preserved and raw food items is a cause of concern. Consequently, the occurrence of foodborne diseases is not rare in these countries either. WHO has recently released the 'Global Strategy for Food Safety 2022-2030', addressing the emerging challenges, new technologies, and innovative approaches to strengthen food safety systems and enhance laboratory capacity for foodborne disease surveillance. Foodborne outbreaks are a huge challenge in India. Malnutrition, anemia, hookworm and enteric infections, are the predominant cryptic health conditions among children in rural and tribal areas, leading to severe consequences, including death, and posing a substantial threat to public health. Combating such events with adequate food safety and hygiene practices is achievable. Systematic collection of data can help to develop food safety policies that could reduce the burden of foodborne diseases. Objective: This review aims to examine the current situation of foodborne and waterborne diseases, identification of the factors contributing to their occurrence and outbreaks, and defining the gaps in control measures, challenges, and potential solutions in improving the public health system. Methods: Strengths, weaknesses, opportunities, and threats (SWOT) analysis was made based on the literature review of foodborne and waterborne infections to assess the current situation and to identify knowledge gaps. Finding: SWOT analysis showed the strength and gaps in the different national initiatives analogous to the global programs. Though, Integrated Disease Surveillance Programme (IDSP), Food Safety and Standards Authority of India (FSSAI), the core Government missions, independently generate substantial information, sporadic and outbreak cases of diarrhea still prevail in the country due to the absence of a systematic national surveillance system. Recently, many government initiatives have been made through Sustainable Development Goals (SDGs), G20 goals, etc. However, potential threats such as risk of zoonotic disease transmission to humans, emerging infections and antimicrobial resistance (AMR), and unauthorized activities in the food sector pose a big challenge in safeguarding the public health. Conclusion: Maintenance of global food safety requires a systematic analysis of present situations, identification of existing shortcomings, and targeted efforts toward prevention of infections. The ongoing G20 mission and the SDGs for 2030 represent significant strides in this direction. To have pathogen-free animals and supply of contamination-free raw foods is impractical, but, mitigating the prevalence of zoonotic diseases can be accomplished by rigorously enforcing hygiene standards throughout the food production chain. A crucial requirement at present is the implementation of integrated laboratory surveillance for foodborne and waterborne infections, as this will provide policymakers and stakeholders all the evidence based scientific information. This system will facilitate efforts in minimizing the risks associated with foodborne and waterborne infections.

The Development of a Clinical Registry Digital Database on Invasive Fungal Infections in India: Advancing Epidemiological Understanding and Patient Care.

A well-structured digital database is essential for any national priority project as it can provide real-time data analysis and facilitate quick decision making. In recent times, particularly after the COVID-19 pandemic, invasive fungal infections (IFIs) have emerged as a significant public health challenge in India, affecting vulnerable population, including immunocompromised individuals. The lack of comprehensive and well-structured data on IFIs has hindered efforts to understand their true burden and optimize patient care. To address this critical knowledge gap, the ICMR has undertaken a Pan-India pioneer initiative to develop a network of Advanced Mycology Diagnostic research centres in different geographical zones of the country (ICMR-MycoNet). Under the aegis of this project, a clinical registry on IFIs in the ICUs is initiated. This process paper presents a detailed account of the steps involved in the establishment of a web-based data entering and monitoring platform to capture data electronically, ensuring robust and secure data collection and management. This system not only allows participating ICMR-MycoNet centres to enter patient information directly into the database using standardized Case Report Form (CRF) but also includes data validation checks to ensure the accuracy and completeness of entered data. It is complemented by a real-time, web-based, and adaptable data visualization platform. This registry aims to provide crucial epidemiological insights, promote evidence-based hospital infection control programs, and ultimately improve patient outcomes in the face of this formidable healthcare challenge.

Pan-Indian Clinical Registry of Invasive Fungal Infections Among Patients in the Intensive Care Unit: Protocol for a Multicentric Prospective Study.

BACKGROUND: Fungal infections are now a great public health threat, especially in those with underlying risk factors such as neutropenia, diabetes, high-dose steroid treatment, cancer chemotherapy, prolonged intensive care unit stay, and so on, which can lead to mycoses with higher mortality rates. The rates of these infections have been steadily increasing over the past 2 decades due to the increasing population of patients who are immunocompromised. However, the data regarding the exact burden of such infection are still not available from India. Therefore, this registry was initiated to collate systematic data on invasive fungal infections (IFIs) across the country. OBJECTIVE: The primary aim of this study is to create a multicenter digital clinical registry and monitor trends of IFIs and emerging fungal diseases, as well as early signals of any potential fungal outbreak in any region. The registry will also capture information on the antifungal resistance patterns and the contribution of fungal infections on overall morbidity and inpatient mortality across various conditions. METHODS: This multicenter, prospective, noninterventional observational study will be conducted by the Indian Council of Medical Research through a web-based data collection method from 8 Advanced Mycology Diagnostic and Research Centers across the country. Data on age, gender, clinical signs and symptoms, date of admission, date of discharge or death, diagnostic tests performed, identified pathogen details, antifungal susceptibility testing, outcome, and so on will be obtained from hospital records. Descriptive and multivariate statistical methods will be applied to investigate clinical manifestations, risk variables, and treatment outcomes. RESULTS: These Advanced Mycology Diagnostic and Research Centers are expected to find the hidden cases of fungal infections in the intensive care unit setting. The study will facilitate the enhancement of the precision of fungal infection diagnosis and prompt treatment modalities in response to antifungal drug sensitivity tests. This registry will improve our understanding of IFIs, support evidence-based clinical decision-making ability, and encourage public health policies and actions. CONCLUSIONS: Fungal diseases are a neglected public health problem. Fewer diagnostic facilities, scanty published data, and increased vulnerable patient groups make the situation worse. This is the first systematic clinical registry of IFIs in India. Data generated from this registry will increase our understanding related to the diagnosis, treatment, and prevention of fungal diseases in India by addressing pertinent gaps in mycology. This initiative will ensure a visible impact on public health in the country. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/54672.

Platelet Function Analysis by Flowcytometry in Thrombocytopenic Trauma Patients.

Hemostasis is dependent on sufficient quantity and quality of circulating functional platelets. Platelet function in trauma patients with thrombocytopenia and its impact on the clinical outcome is not adequately explored. Whether platelet dysfunction has a role in the pathogenesis of acute traumatic coagulopathy needs to be studied. Blood samples were collected from 70 thrombocytopenic trauma patients before transfusing platelets and assessed for platelet activation and platelet aggregation using flowcytometry. Primary outcome was in-hospital mortality. Platelet dysfunction was identified in 57.1% of thrombocytopenic trauma patients. A weak inverse correlation between percentage of activated platelets and APTT was observed (Spearman coefficient - 0.25, p = 0.03). A sensitivity and specificity of 66.6% was achieved for a cut off of ≤ 6.5% of platelet activation post trauma with ROC-AUC of 0.658 for identifying coagulopathy. No correlation with mortality however was observed (p > 0.05). Platelet dysfunction had a weak association with coagulopathy suggesting limited contribution of platelet dysfunction in pathogenesis of acute traumatic coagulopathy and warrants further research.

Effect of Time Lag from Injury to Surgery on the Temporal Expression of Growth Factors After Intramedullary Nailing of Isolated Fracture of Femur Shaft.

BACKGROUND: Growth factors are considered to play an important role in the process of bone healing. This study assessed serum levels of transforming growth factor-ß1 (TGF-ß1) and vascular endothelial growth factor (VEGF) in patients undergoing intramedullary nailing for isolated fracture of femur shaft operated at various time lag from injury. PATIENTS AND METHODS: All patients between 18 and 60 years of age group operated for isolated femoral shaft fractures (AO/OTA32 A, B, C) were included. The serum levels of VEGF and TGF-ß1 were compared at various intervals amongst the study group divided into two groups based on the time lag between injury and surgery along with a health control cohort. RESULTS: 31 patients were operated within the first 48 h while 28 patients were operated within 2-12 days after injury. Highest VEGF levels were observed on postop day 3, followed by a subsequent decline thereafter. TGF-ß1 level also showed increasing trend after surgery, but the levels reached dual peaks after 2 weeks and 12 weeks after surgery. Both groups revealed similar trends of temporal expression of serum VEGF and TGF-ß1. There was no statistical difference between the two groups at any point of time during the observation period. There was also no statistical difference in clinico-radiological healing of fractures among the groups. CONCLUSION: There is a definite and specific trend of serum levels of growth factors in the fracture healing process. There is no effect of time lag from injury to surgery on the healing outcome of isolated femoral shaft fractures both at the molecular level and also at the clinical level.

Efficacy of Thromboelastography (TEG) in Predicting Acute Trauma-Induced Coagulopathy (ATIC) in Isolated Severe Traumatic Brain Injury (iSTBI).

To evaluate the efficacy of point-of-care thromboelastography (TEG) to predict acute trauma-induced coagulopathy (ATIC) in isolated severe TBI (iSTBI). We conducted an observational diagnostic cohort. Patients for whom TEG was performed before blood transfusion were stratified by conventional coagulation tests (CCTs) on admission and classified as "ATIC" (prothrombin time ≥ 16.70 s; international normalized ratio ≥ 1.27; activated partial thromboplastin time ≥ 28.80 s) (n = 24) or "no ATIC" (n = 34). Univariate analysis to compare groups, receiver operating characteristic analysis to establish cut-off and diagnostic validation was done. Fifty-eight patients were included [32(25-45) years; 97% male; GCS 6.3 ± 1.5]. 41% developed ATIC. Compared to no-ATIC, ATIC group had significantly prolonged κ-time (4.6 vs. 2.5 min; p = 0.01) and shortened α-angle (40.2° vs. 56.3°; p = 0.03). A cut-off for κ-time ≥ 3.7 (AUC 0.68 95% CI 0.54-0.82, specificity 70%, sensitivity 63%) and α angle ≤ 48.0 (AUC 0.66, 95% CI 0.51-0.81, specificity 67%, sensitivity 67%) was established. The diagnostic accuracy of this cut-off for identifying ATIC, was 55.6% with sensitivity (81.8%) and specificity (14.3%). TEG may be a clinically sensitive test for identifying the underlying coagulopathy following TBI. However confirmation with CCTs is recommended.

Early posttraumatic changes in coagulation and fibrinolysis systems in isolated severe traumatic brain injury patients and its influence on immediate outcome.

OBJECTIVE/BACKGROUND: Early coagulopathy in isolated severe traumatic brain injury occurs despite the lack of severe bleeding, shock, and fluid administration. We aimed to correlate coagulation activation/inhibition, thrombin generation and fibrinolysis with the development of acute trauma induced coagulopathy (TIC) and its effects on early mortality in isolated severe traumatic brain injury (iSTBI) patients. METHODS: A prospective screening of iSTBI patients was done for two years. History of anticoagulants, liver disease, hypotension, extracranial injuries, transfusion, brain death were excluded. TIC was defined as international normalized ratio (INR) ≥ 1.27 and/or prothrombin time (PT) ≥ 16.7 seconds and/or activated partial thromboplastin Time (aPTT) ≥ 28.8 seconds on admission following iSTBI. Analysis of tissue factor (TF), tissue factor pathway inhibitor (TFPI), protein C (PC), protein S (PS), thrombin/antithrombin complex (TAT), soluble fibrin monomer (sFM), tissue plasminogen activator (tPA) and plasminogen activator inhibitor-1 (PAI-1) was done. Cases were categorized as presence or absence of TIC and 20 healthy controls participants were included. RESULTS: A total of 120 cases met the inclusion criteria, aged 35.7 ±â€¯12.12 years, 96% males. TIC was identified in 50 (41.6%). TIC occurred independently of age, sex, Glasgow coma scale (GCS) but was associated with acidosis (60%; p = .01). Following iSTBI significant decline was seen in coagulation activation. Thrombin generation and fibrinolysis were markedly increased. TF, TFPI, PC and PS were low in TIC compared with control. Significant depletion of PS was seen in TIC versus No-TIC. TBI patients with depleted PS had an odds ratio (OR) of 7.10 (1.61-31.2) for TIC. Receiver operating characteristic curve (ROC) analysis depicted area under the curve (AUC) of 0.73 (95% confidence interval [CI] 0.63-0.84) with a cut-off of ≥74 of PS (specificity 63.9%, sensitivity 72.7%). In-hospital mortality was higher in TIC group (44%) compared with no-TIC (20%) with OR of 4.73 (95% CI 1.68-13.3) and hazard ratio [HR] of 2.8 (95 % CI 1.2-6.4). CONCLUSION: Incidence of TIC in iSTBI is 41.6%, with 4.7 times odds for mortality. Traumatic brain injury causes enhanced coagulation activation, inadequate inhibition, exacerbation of thrombin generation, and subsequent increased fibrinolysis. ROC curve analysis revealed a cut-off of PS ≤ 74 with specificity 63.8%, sensitivity 72.7% for development of TIC.

Acute Traumatic Endotheliopathy in Isolated Severe Brain Injury and Its Impact on Clinical Outcome.

STUDY DESIGN: Prospective observational cohort. OBJECTIVE: To investigate the difference in plasma levels of syndecan-1 (due to glycocalyx degradation) and soluble thrombomodulin (due to endothelial damage) in isolated severe traumatic brain injury (TBI) patients with/without early coagulopathy. A secondary objective was to compare the effects of the degree of TBI endotheliopathy on hospital mortality among patients with TBI-associated coagulopathy (TBI-AC). METHODS: Data was prospectively collected on isolated severe TBI (sTBI) patients with Glasgow Coma Scale (GCS) ≤8 less than 12 h after injury admitted to a level I trauma centre. Isolated sTBI patients with samples withdrawn prior to blood transfusion were stratified by conventional coagulation tests as coagulopathic (prothrombin time (PT) ≥ 16.7 s, international normalized ratio (INR) ≥ 1.27, and activated partial thromboplastin time (aPTT) ≥ 28.8 s) and non-coagulopathic. Twenty healthy controls were also included. Plasma levels of thrombomodulin and syndecan-1 were estimated by ELISA. With receiver operating characteristic curve (ROC) analysis, we defined endotheliopathy as a syndecan-1 cut-off level that maximized the sum of sensitivity and specificity for predicting TBI-AC. RESULTS: Inclusion criteria were met in 120 cases, with subjects aged 35.5 ± 12.6 years (88.3% males). TBI-AC was identified in 50 (41.6%) patients, independent of age, gender, and GCS, but there was an association with acidosis (60%; p = 0.01). Following isolated sTBI, we found insignificant changes in soluble thrombomodulin (sTM) levels between patients with isolated TBI and controls, and sTM levels were lower in coagulopathic compared to non-coagulopathic patients. Elevations in plasma syndecan-1 (ng/mL) levels were seen compared to control (31.1(21.5-30.6) vs. 24.8(18.5-30.6); p = 0.08). Syndecan-1(ng/mL) levels were significantly elevated in coagulopathic compared to non-coagulopathic patients (33.7(21.6-109.5) vs. 29.9(19.239.5); p = 0.03). Using ROC analysis (area under the curve = 0.61; 95% Confidence Interval (CI) 0.50 to 0.72), we established a plasma syndecan-1 level cutoff of ≥30.5 ng/mL (sensitivity % = 55.3, specificity % = 52.3), with a significant association with TBI-associated coagulopathy. CONCLUSION: Subsequent to brain injury, elevated syndecan-1 shedding and endotheliopathy may be associated with early coagulation abnormalities. A syndecan-1 level ≥30.5 ng/mL identified patients with TBI-AC, and may be of importance in guiding management and clinical decision-making.

RANTES levels in peripheral blood, CSF and contused brain tissue as a marker for outcome in traumatic brain injury (TBI) patients.

BACKGROUND: Traumatic brain injury (TBI) causes activation of several neurochemical and physiological cascades, leading to neurological impairment. We aimed to investigate the level of novel chemokine RANTES in plasma, cerebrospinal fluid (CSF) and contused brain tissue in traumatic brain injury patients and to correlate the expression of this chemokine with the severity of head injury and neurological outcome. METHODS: This longitudinal case control study was performed on 70 TBI patients over a period of 30 months. Glasgow coma scale (GCS) and Glasgow outcome score were used to assess the severity of head injury and clinical outcome. Level of RANTES was quantified in plasma (n = 60), CSF (N = 10) and contused brain tissue (n = 5). Alterations in the plasma levels on 1st and 5th day following TBI were assessed. Patients were categorized as severe (GCS < 8) (SHI), moderate and mild Head injury (GCS > 8-14). 15 healthy volunteers were taken as the control group. RESULTS: The median plasma RANTES levels were 971.3 (88.40-1931.1); 999.2 (31.2-2054.9); 471.8 (370.9-631.9) for SHI, MHI and healthy control respectively and showed statistically significant variation (p = 0.005). There was no statistical difference in the mean 1st and 5th day RANTES levels for the SHI group. However, admission RANTES levels were significantly higher in patients who died than those who survived (p = 0.04). Also, RANTES levels were significantly higher in plasma as compared to contused brain tissue and CSF (p = 0.0001). CONCLUSION: This is the first study of its kind which shows that there is significant correlation of admission RANTES levels and early mortality. Another interesting finding was the significant upregulated in the expression of RANTES in plasma, compared to CSF and contused brain tissue following severe TBI.

Association Between the Pancreatic Enzyme Level and Organ Failure in Trauma Patients.

BACKGROUND: The literature suggests an association of pancreatic enzymes with systemic inflammation resulting in secondary organ injury and dysfunction following trauma. Elevation in serum enzymes may not always be predictive of pancreatic disease, and can reflect extra pancreatic production. OBJECTIVES: This study was conducted to evaluate the rise in serum pancreatic enzyme levels with the incidence of organ failure following trauma. PATIENTS AND METHODS: A retrospective review was performed on critically injured patients from December 2009 to March 2010. Patient's clinical demographics, routine laboratory investigations along with amylase and lipase levels were also extracted from the patients' records. Patients with pancreatic or duodenal injuries were excluded from the study. RESULTS: From a total of 296 patients (mean age, 31 years), 85% were males. Blunt injury was seen in 91.6% of the cases and 8.4% had penetrating injury. One hundred and fifty-three patients had single organ failure, 96 had multiple organ failure and 47 had no organ failure. There was a significant difference in lipase levels (P = 0.04), potassium levels (P = 0.05) and hemoglobin levels (P = -0.004), among the three patient groups. There was no significant difference in amylase levels among the three patient groups. The observed independent predictors of mortality included coagulopathy (OR = 1.7), Glasgow coma scale (OR = 1.1, 4.7), pulmonary failure (OR = 0.0004), hepatic failure (OR = 0.048), renal failure (OR = 5.5), organ failure (OR =149.8), lipase levels (OR = 1.3), and infection (OR = 3.0). CONCLUSIONS: There was a significant correlation between elevated lipase levels and the incidence of multiple organ failure. Moreover, No significant association was found between the elevated amylase levels and organ failure. However, on admission, measurement of these enzymes coupled with routine laboratory investigations can be a powerful tool in the early detection of patients progressing towards organ failure.

Establishing a normal reference range for thromboelastography in North Indian healthy volunteers.

BACKGROUND: Thromboelastography (TEG) is relatively recent assay to analyze the coagulation state of a blood sample, providing a continuous visualization of physical changes occurring during blood coagulation. There is a paucity of published literature on assessment of coagulation status using TEG in Indian population. AIM: The primary aim of the following study is to establish normal reference values for TEG in North Indian healthy volunteers and secondary aim is to compare them with conventional plasma-based routine coagulation tests and the manufacturers reference range. MATERIALS AND METHODS: A total of 200 healthy volunteers comprised of 100 males and 100 females of age groups between 20 and 50 years, were enrolled over a period of 1 year, i.e., 2011-2012. Thromboelastometry (TEM) was performed on TEM-A automated thromboelastometer (Framar Biomedica, Rome, Italy), using whole blood non-additive (360 µl). TEG parameters analyzed were r-time, k-time, α-angle, maximal amplitude (MA). Prothrombin time (PT), activated partial thromboplastin time (aPTT) and platelet count was performed for all volunteers. The 95% reference range was calculated as (mean-1.96 standard deviation [SD]) to (mean + 1.96 SD). RESULTS: Our reference values for 95% of 200 volunteers were r-time: 1.8-14.2 min, k-time: 0.7-7.3 min, α-angle: 27.3-72.3° and MA: 32.1-87.9 mm. Maximum clot strength was higher in women compared with men, however statistically insignificant. Overall 14.5% (29/200) of the volunteers had at least one abnormal parameter while 74% (149/200) had deranged TEG values using the manufacturer's reference range. Statistically significant variation was seen in r-time for 84.8% (P < 0.001), for k-time, in 87.1% (P < 0.001), for α-angle in 83.7% (P < 0.001) and for MA in 84% (P < 0.001), between the manufacturer and our reference range. CONCLUSION: The efficacy of classical coagulation test has been well-established; on the contrary TEG is a fairly recent assay and its utility for patient management remains to be demonstrated. We observed TEG to be oversensitive in determining coagulopathy where there is no clinical presentation. The manufacturer's reference values may not be appropriate for different ethnicity. TEG may give an overall representation of hemostasis; however, it cannot replace the conventional coagulation tests. We recommend the determination of normal TEG values by each laboratory for their target population.

Evaluation of the utility of thromboelastography in a tertiary trauma care centre.

Background. Thromboelastography (TEG) unlike conventional coagulation assays evaluates the dynamic interaction of clotting factors and platelets indicating an overall clot quality. Literature assessing the efficacy of TEG in identifying trauma associated bleeding is lacking. Aim. To compare TEG with conventional plasma based coagulation tests and assess whether TEG can serve as a screening test or replace the conventional routine test. Materials. Retrospective data was collected for 150 severe trauma patients. Patients with known evidence of severe comorbidities, which may influence the outcome, were excluded. Detailed evaluation of the patient's clinical and laboratory records was conducted. Diagnostic characteristics such as sensitivity, specificity, and accuracy were calculated. Results. Fifty-one patients were defined as coagulopathic by the conventional coagulation test, 30 by the laboratory established range for TEG indices and 105 by manufactures range. Specificity and sensitivity for the laboratory established range for TEG were 29.4% and 84.8%; for manufactures range sensitivity was 74.5%, specificity was 32.3%. Conclusion. We observed that conventional coagulation assays are the most sensitive tests for diagnosis of coagulopathy due to trauma. However in emergency trauma situations, where immediate corrective measures need to be taken, coagulation parameters and conventional coagulation tests may cause delay. TEG can give highly specific results depicting the underlying coagulopathy.

An audit of fresh frozen plasma usage in a tertiary trauma care centre in north India.

Fresh frozen plasma (FFP) transfusion is a crucial part of management of trauma patients. There is a paucity of literature about the audit of appropriateness of FFP use in trauma patients. To evaluate and analyze the appropriateness of FFP transfusion practices for trauma patients. Prospectively compiled blood bank records of FFP transfusion practices over a period of 4 months from Augusts'08 through Deember'08 were retrospectively analyzed for 207 patients. The number of FFP units used in all these trauma patients were evaluated a propos the cause of injury, departments, type of surgery, presence of coagulopathy, bleeding, massive transfusion, length of hospital stay and patient outcome. Trauma scores such as Glasgow coma score and injury severity score were also calculated to estimate the severity of injury. The appropriateness of FFP transfusion was assessed according to the guidelines drafted by the College of American Pathologists. FFP transfusion for patients experiencing active bleeding, micro vascular bleeding, coagulopathy and/or massive transfusion, was deemed appropriate. Patients receiving FFP were categorized and individually correlated with the outcome. The influences of other variables which affect patient outcome were excluded using stepwise multivariate logistic regression analysis. p value < 0.05 were considered to be statistically significant. A total of 207 trauma patients were included in the study, 183 (88.4 %) males and 24 (11.6 %) females. The FFP use among neurosurgery patients was 46.9 %, general surgery patients 40.6 % and orthopedics 12.6 %. Appropriate use of FFP was 49.5 % according to the CAP guidelines. Trauma patients who required FFP as a part of treatment were categorized as; Patients who had bleeding alone (n = 40), bleeding with coagulopathy (n = 16), and coagulopathy alone (n = 43), and further correlated with the outcome and were found statistically insignificant. The prevalence of appropriate use of FFP at trauma centre was 49.5 %. The FFP use by neurosurgery:orthopedics:general surgery was 5:1:4. The highest appropriate FFP use was by Neurosurgery department (50.5 %). Assessing the pattern of usage and rate of misuse of FFP units, allows us to establish required strategies to improve the state of affairs.

Assessment of hemostatic changes after crystalloid and colloid fluid preloading in trauma patients using standard coagulation parameters and thromboelastography.

BACKGROUND: The choice of an ideal fluid administered post trauma and its subsequent influence on coagulation still poses a clinical dilemma. Hence, this study was designed to assess the influence of in vivo hemodilution with various fluid preparations (4% gelatin, 6% hydoxyethyl starch (HES), Ringer's lactate, 0.9% normal saline) on coagulation using standard coagulation parameters and real-time thromboelastography (TEG) in patients undergoing elective surgery post trauma. METHODS: In a randomized, double-blind study, 100 patients of either sex and age, belonging to ASA Grades I and II, scheduled for elective surgeries were allocated into four groups of 25 each according to the type of fluid infused. Group G (4% gelatin), Group N (0.9% normal saline), Group R (Ringer's lactate), and Group H (6% HES) received preloading with 1 L of fluid according to the group. The coagulation status of the patients was assessed during perioperative period (before surgery, after fluid preloading, and at the end of the surgery) using both conventional coagulation analysis and TEG. STATISTICAL ANALYSIS: Analysis of variance (ANOVA), post hoc and Pearson Chi-square test were used. RESULTS: In all the patients preloaded with gelatin, there was a significant increase in prothrombin time index (PTI; 14.88±0.90 vs. 13.78±3.01, P<0.001) and international normalized ratio (INR; 1.12±0.09 vs. 1.09±0.19, P<0.05) compared to the baseline value. An increase was observed in these parameters in the postoperative period also. In the HES group, there was statistically significant increase in PT time (15.70±1.51 vs. 13.74±0.75, P=0.01) and INR (1.20±0.15 vs. 1.03±0.17, P<0.001) as compared to the baseline. In the intergroup comparisons, the patients preloaded with HES had a significant increase in INR (1.20±0.15 vs. 1.12±0.09, P=0.04) and reaction time (R time; 6.84±2.55 min vs. 4.79±1.77 min, P=0.02) as compared to the gelatin group. The fall in coagulation time (k time; 2.16±0.98 vs. 3.94±2.6, P=0.02), rise in maximum amplitude (MA; 61.94±14.08 vs. 50.11±14.10, P=0.04), and rise in A20 (56.17±14.66 vs. 43.11±14.24, P=0.05) were more in patients preloaded with RL as compared to the HES group. 100% patients in the gelatin group, 84.2% patients in the NS group, 94.4% patients in the RL group, and 66.7% patients in the HES group had hypocoagulable (R time > 14 min) state in the postoperative period. CONCLUSION: Crystalloids are optimal volume expanders in trauma, with RL having beneficial effects on coagulation system (decrease in k time and increase in MA and A20). Among the colloids, HES 6% (130/0.4) affects coagulation parameters (increase in PTI, INR, R time, k time) more than gelatin. Trial registration (protocol number-IEC/NP-189/2011).

Incidence, clinical predictors and outcome of acute renal failure among North Indian trauma patients.

CONTEXT: There is a need for identifying risk factors aggravating development of acute renal failure after attaining trauma and defining new parameters for better assessment and management. Aim of the study was to determine the incidence of acute renal failure among trauma patients, and its correlation with various laboratory and clinical parameters recorded at the time of admission and in-hospital mortality. SUBJECTS AND METHODS: The retrospective cohort study included admitted 208 trauma patients over a period of one year. 135 trauma patients at the serum creatinine level >2.0 mg/dL were enrolled in under the group of acute renal failure. 73 patients who had normal creatinine level made the control group. They were further assessed with clinical details and laboratory investigations. RESULTS: Incidence of acute renal failure was 3.1%. There were 118 (87.4%) males and average length of stay was 9 (1, 83) days. Severity of injury (ISS, GCS) was relatively more among the renal failure group. Renal failure was transient in 35 (25.9%) patients. They had higher incidence of bone fracture (54.0%) (P= 0.04). Statistically significant association was observed between patients with head trauma and mortality 72 (59.0%) (P= 0.001). Prevalence of septic 24 (59.7%) and hemorrhagic 9 (7.4%) shock affected the renal failure group. CONCLUSION: Trauma patients at the urea level >50 mg/dL, ISS >24 on the first day of admission had 23 times and 7 times the risk of developing renal failure. Similarly, patients with hepatic dysfunction and pulmonary dysfunction were 12 times and 6 times. Patients who developed cardiovascular dysfunction, hematological dysfunction and post-trauma renal failure during the hospital stay had risk for mortality 29, 7 and 8 times, respectively. The final prognostic score obtained was: 14*hepatic dysfunction + 11*cISS + 18*cUrea + 12*cGlucose + 10*pulmonary dysfunction. Optimal score cut-off for prediction of renal failure was found to be ≥25 with specificity, sensitivity and positive likelihood ratio to be 84.9%, 78.4% and 3.9, respectively.

Evaluation of amylase and lipase levels in blunt trauma abdomen patients.

BACKGROUND: There are studies to prove the role of amylase and lipase estimation as a screening diagnostic tool to detect diseases apart from acute pancreatitis. However, there is sparse literature on the role of serum and urine amylase, lipase levels, etc to help predict the specific intra-abdominal injury after blunt trauma abdomen (BTA). AIM: To elucidate the significance of elevation in the levels of amylase and lipase in serum and urine samples as reliable parameters for accurate diagnosis and management of blunt trauma to the abdomen. MATERIALS AND METHODS: A prospective analysis was done on the trauma patients admitted in Jai Prakash Narayan Apex Trauma Center, AIIMS, with blunt abdomen trauma injuries over a period of six months. Blood and urine samples were collected on days 1, 3, and 5 of admission for the estimation of amylase and lipase, liver function tests, serum bicarbonates, urine routine microscopy for red blood cells, and complete hemogram. Clinical details such as time elapsed from injury to admission, type of injury, trauma score, and hypotension were noted. Patients were divided into groups according to the single or multiple organs injured and according to their hospital outcome (dead/discharged). Wilcoxon's Rank sum or Kruskal-Wallis tests were used to compare median values in two/three groups. Data analysis was performed using STATA 11.0 statistical software. RESULTS: A total of 55 patients with median age 26 (range, 6-80) years, were enrolled in the study. Of these, 80% were males. Surgery was required for 20% of the patients. Out of 55 patients, 42 had isolated single organ injury [liver or spleen or gastrointestinal tract (GIT) or kidney]. Patients with pancreatic injury were excluded. In patients who suffered liver injuries, urine lipase levels on day 1, urine lipase/amylase ratio along with aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) on days 1, 3, and 5, were found to be significant. Day 1 serum amylase, AST, ALT, hemoglobin, and hematocrit levels were found significant in patients who had spleen injury. Serum amylase levels on day 5 and ALP on day 3 were significant in patients who had GIT injury. Urine amylase levels on day 5 were found to be statistically significant in patients who had kidney injury. In patients with isolated organ injury to the liver or spleen, the levels of urine amylase were elevated on day 1 and gradually decreased on days 3 and 5, whereas in patients with injury to GIT, the urine amylase levels were observed to gradually increase on days 3 and 5. CONCLUSION: Although amylase and lipase levels in the serum and urine are not cost-effective clinical tools for routine diagnosis of extra-pancreatic abdominal injuries in BTA, but when coupled with other laboratory tests such as liver enzymes, they may be significant in predicting specific intra-abdominal injury.

Maximum surgical blood ordering schedule in a tertiary trauma center in northern India: A proposal.

CONTEXT: Over ordering of blood is a common practice in elective surgical practice. Considerable time and effort is spent on cross-matching for each patient undergoing a surgical procedure. AIMS: The aim of this study was to compile and review the blood utilization for two key departments (Neurosurgery and Surgery) in a level 1 trauma center. A secondary objective was to formulate a rational blood ordering practice for elective procedures for these departments. MATERIALS AND METHODS: Analysis of prospectively compiled blood bank records of the patients undergoing elective surgical, neurosurgical procedures was carried out between April 2007 and March 2009. Indices such as the cross-matched/transfused ratio (C/T ratio), transfusion index and transfusion probability were calculated. The number of red cell units required for each procedure was calculated using the equation proposed by Nuttall et al, using preoperative hemoglobin and postoperative hemoglobin for each elective surgical procedure. RESULTS: There were 252 surgery patients (age range: 2-80 years) in the study. One thousand and eighty-eight units of blood were cross-matched, 432 were transfused (CT ratio 2.5). 44.0% patients did not require transfusion during entire hospital stay. Three (50%) elective procedures had CT ratio >2.5and 4 (66.6%) elective procedures had TI <0.5. There were 200 neurosurgery patients (age range: 2-62 years) in the study. Total 717 units of blood were cross-matched and 161 transfused (CT ratio 4.5). Nine elective procedures had CT ratio >2.5, with five of them exceeding 4. In procedures like spinal instrumentation the CT ratio was <2.5 and 10 (90.9%) of elective procedures had TI <0.5. CONCLUSIONS: In this study 40% and 22% of cross-matched blood was being utilized for elective general surgery and neurosurgical procedures, respectively. The calculated required blood units for all elective Trauma surgery procedures were more than 2 units. The calculated required blood units were less than 0.5 units in four of the 11 neurosurgical procedures, and hence only one unit should be arranged for them. It is crucial for every institutional blood bank to formulate a blood ordering schedule. Regular auditing and periodic feedbacks are also vital to improve the blood utilization practices.