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1.
Transfusion ; 64(7): 1207-1216, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38752381

ABSTRACT

BACKGROUND: Hospital transfusion services order blood products to satisfy orders and maintain inventory levels during unexpected periods of increased blood demand. Surplus inventory may outdate before being allocated to a recipient. Blood product outdating is the largest contributor to blood wastage. STUDY DESIGN: A province-wide redistribution program was designed and implemented to redistribute near-outdate plasma protein and related blood products from low-usage to high-usage hospitals. Program operations and details are described in this paper. Two transport container configurations were designed and validated for transport of all blood products. A cost-analysis was performed to determine the effectiveness of this redistribution program. RESULTS: A total of 130 hospital transfusion services contributed at least one near-outdate blood product for redistribution between January 2012 and March 2020. These services redistributed 15,499 products through 3412 shipments, preventing the outdating of $17,570,700 CAD worth of product. Program costs were $14,900 for shipping and $30,000 for staffing. Failed time limits or non-compliance with packing configurations resulted in $388,200 worth of blood products (97 shipments containing 816 products) being discarded. Courier transport delays was the most common reason (42/97; 43%) for transport failure. CONCLUSION: Redistributing near-outdate blood products between hospitals is a feasible solution to minimize outdating. Despite heterogeneity of Canadian blood product inventory, all products (each with unique storage and transport requirements) were successfully redistributed in one of two validated and simple containers. Total operation costs of this program were small in comparison to the $17.6 million in savings associated with preventing the discard of outdated products.


Subject(s)
Blood Transfusion , Humans , Blood Transfusion/economics , Blood Preservation/methods , Blood Preservation/economics , Blood Banks/economics , Hospitals , Inventories, Hospital , Medical Waste/economics
2.
Vox Sang ; 2024 May 03.
Article in English | MEDLINE | ID: mdl-38699884

ABSTRACT

BACKGROUND AND OBJECTIVES: West Nile virus (WNV) and Usutu virus (USUV) are mosquito-borne flaviviruses (Flaviviridae) that originated in Africa, have expanded their geographical range during the last decades and caused documented infections in Europe in the last years. Acute WNV and USUV infections have been detected in asymptomatic blood donors by nucleic acid testing. Thus, inactivation of both viral pathogens before blood transfusion is necessary to ensure blood product safety. This study aimed to investigate the efficacy of the THERAFLEX UV-Platelets system to inactivate WNV and USUV in platelet concentrates (PCs). MATERIALS AND METHODS: Plasma-reduced PCs were spiked with the virus suspension. Spiked PC samples were taken after spiking (load and hold sample) and after UVC illumination on the Macotronic UV illumination machine with different light doses (0.05, 0.1, 0.15 and 0.2 (standard) J/cm2). Virus loads of WNV and USUV before and after illumination were measured by titration. RESULTS: Infectivity assays showed that UVC illumination inactivated WNV and USUV in a dose-dependent manner. At a UVC dose of 0.2 J/cm2, the WNV titre was reduced by a log10 factor of 3.59 ± 0.43 for NY99 (lineage 1) and 4.40 ± 0.29 for strain ED-I-33/18 (lineage 2). USUV titres were reduced at the same UVC dose by a log10 factor of 5.20 ± 0.70. CONCLUSIONS: Our results demonstrate that the THERAFLEX UV-Platelets procedure is an effective technology to inactivate WNV and USUV in contaminated PCs.

3.
J Surg Res ; 295: 683-689, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38128347

ABSTRACT

INTRODUCTION: Resuscitative thoracotomy (RT) in the setting of traumatic arrest serves as a vital but resource-intensive intervention. The COVID-19 pandemic has created critical shortages, sharpening the focus on efficient resource utilization. This study aims to compare RT performance and blood product utilization before and after the onset of the COVID-19 pandemic for patients in traumatic cardiac arrest. METHODS: All patients undergoing RT for traumatic cardiac arrest in the emergency department at our American College of Surgeons-verified Level 1 trauma center (August 01, 2017-July 31, 2022) were included in this retrospective observational study. Study groups were dichotomized into pre-COVID (before October 03, 2020) versus COVID (from October 03, 2020 on) based on patient arrival date demographics, clinical/injury data, and outcomes were collected. The primary outcome was blood product transfusion <4 h after presentation. RESULTS: 445 RTs (2% of 23,488 trauma encounters) were performed over the study period: Pre-COVID, n = 209 (2%) versus COVID, n = 236 (2%) (P = 0.697). Survival to discharge was equivalent Pre-COVID versus COVID (n = 22, 11% versus n = 21, 9%, P = 0.562). RT patients during COVID consumed a median of 1 unit less packed red blood cells at the 4 h measurement (3.0 [1.8-7.0] versus 3.9 [2.0-10.0] units, P = 0.012) and 1 unit less of platelets at the 4 h measurement (4.3 [2.6-10.0] versus 5.7 [2.9-14.4] units, P = 0.012) compared to Pre-COVID. These findings were persistent after performing multivariable negative binomial regression. CONCLUSIONS: Rates of RT and survival after RT remained consistent during the pandemic. Despite comparable RT frequency, packed red blood cells and platelet transfusions were reduced, likely reflecting resource expenditure minimization during the severe blood shortages that occurred during the pandemic. RT performance for patients in traumatic arrest may, therefore, be feasible during global pandemics at prepandemic frequencies as long as particular attention is paid to resource expenditure.


Subject(s)
COVID-19 , Heart Arrest , Humans , Thoracotomy , Pandemics , Injury Severity Score , Resuscitation , Retrospective Studies , COVID-19/epidemiology
4.
Pediatr Blood Cancer ; 71(1): e30753, 2024 Jan.
Article in English | MEDLINE | ID: mdl-37899699

ABSTRACT

For children with cancer, blood product transfusions are crucial, but can be complicated by transfusion reactions. To prevent these complications, premedication is often given, although not always evidence-based. Herein, we describe a significant decrease in the use of premedication (72%-28%) at our institution after the implementation of standardized guidelines, without an increase in transfusion reactions (3.2% prior vs. 1.5% after standardization). Importantly, there were no severe transfusion reactions leading to hospitalization or death. Our results provide evidence in favor of more judicious use of premedication prior to transfusions in patients 21 years and younger being treated for cancer.


Subject(s)
Neoplasms , Transfusion Reaction , Child , Humans , Quality Improvement , Blood Transfusion , Neoplasms/therapy , Premedication
5.
J Cardiothorac Vasc Anesth ; 38(5): 1135-1143, 2024 May.
Article in English | MEDLINE | ID: mdl-38413344

ABSTRACT

OBJECTIVE: To demonstrate the value of a viscoelastic-based intraoperative transfusion algorithm to reduce non-RBC product administration in adult cardiac surgical patients. DESIGN: A prospective observational study. SETTING: At a quaternary academic teaching hospital. PARTICIPANTS: Cardiac surgical patients. INTERVENTIONS: Viscoelastic-based intraoperative transfusion algorithm. MEASUREMENTS AND MAIN RESULTS: The study authors compared intraoperative blood product transfusion rates in 184 cardiac surgical patients to 236 historic controls after implementing a viscoelastic-based algorithm. The authors found a non-significant reduction in transfusion of 23.8% for fresh frozen plasma (FFP) units (0.84 ± 1.4 v 0.64 ± 1.38; p = ns), 33.4% for platelet units (0.90 ± 1.39 v 0.60 ± 131; p = ns), and 15.8% for cryoprecipitate units (0.19 ± 0.54 v 0.16 ± 0.50; p = ns). They found a 43.9% reduction in red blood cell (RBC) units transfused (1.98 ± 2.24 v 0.55 ± 1.36; p = 0.008). There were no statistically significant differences in time to extubation (8.0 hours (4.0-21.0) v 8.0 (4.0-22.3), reoperation for bleeding (15 [12.3%] v 10 [10.6%]), intensive care unit length of stay (ICU LOS) (51.0 hours [28.0-100.5] v 53.5 [33.3-99.0]) or hospital LOS (9.0 days [6.0-15.0] v 10.0 [7.0-17.0]). Deviation from algorithm adherence was 32.7% (48/147). Packed RBC, FFP, platelets, cryoprecipitate, and cell saver were significantly reduced in the Algorithm Compliant Cohort compared with historic controls, whereas times to extubation, ICU LOS, and hospital LOS did not reach significance. CONCLUSIONS: After the implementation of a viscoelastic-based algorithm, patients received fewer packed RBC, FFP, platelets, cryoprecipitate, and cell saver. Algorithm-compliant patients received fewer transfusions; however, reductions in times to extubation, ICU LOS, and hospital LOS were not statistically significant compared with historic controls.


Subject(s)
Blood Transfusion , Cardiac Surgical Procedures , Adult , Humans , Coronary Artery Bypass , Hemorrhage , Algorithms , Retrospective Studies
6.
Pediatr Cardiol ; 2024 Jun 20.
Article in English | MEDLINE | ID: mdl-38902366

ABSTRACT

Thrombosis, a major adverse event of congenital heart surgery, has been associated with poor outcomes. We hypothesized that in CHD patients undergoing cardiac surgery, increased perioperative use of pro-coagulant products may be associated with postoperative thrombosis in the setting of hyperfibrinogenemia, leading to greater hospital and blood product costs. Single-center retrospective study. Data from Boston Children's Hospital's electronic health record database was used in this study. All patients undergoing congenital heart surgery between 2015 and 2018 with postoperative fibrinogen levels above 400 mg/dl were reviewed. Of 334 patients with high plasma fibrinogen levels, 28 (8.4%) developed postoperative thrombosis (median age: one year, 59% male). In our cohort, 25 (7%) demonstrated evidence of baseline hypercoagulability by one or more panel test results. Thrombosis was associated with greater hospital and blood product costs, longer ventilation times, and longer hospital and ICU length of stays. Preoperative hypercoagulable state (odds ratio: 2.58, 95% CI [1.07, 9.99], p = 0.002), postoperative red blood cell transfusion (odds ratio: 1.007, 95% CI [1.000, 1.015], p = 0.04), and single ventricle physiology (univariate odds ratio: 2.94, 95% CI [1.09, 7.89], p = 0.03) were predictors of postoperative thrombosis. Preoperative hypercoagulable state and intraoperative platelet transfusion were predictors of hospital cost. Thrombosis was associated with worse in-hospital outcomes and higher costs. Preoperative hypercoagulable state and postoperative red blood cell transfusion were significant predictors of thrombosis. Risk prediction models that can guide thrombosis prevention are needed to improve outcomes of patients undergoing congenital heart surgery.

7.
Annu Rev Biomed Eng ; 24: 111-135, 2022 06 06.
Article in English | MEDLINE | ID: mdl-35231178

ABSTRACT

Uncontrolled bleeding is a major problem in trauma and emergency medicine. While materials for trauma applications would certainly find utility in traditional surgical settings, the unique environment of emergency medicine introduces additional design considerations, including the need for materials that are easily deployed in austere environments. Ideally, these materials would be available off the shelf, could be easily transported, and would be able to be stored at room temperature for some amount of time. Both natural and synthetic materials have been explored for the development of hemostatic materials. This review article provides an overview of classes of materials used for topical hemostats and newer developments in the area of injectable hemostats for use in emergency medicine.


Subject(s)
Biocompatible Materials , Hemostatics , Hemorrhage , Hemostasis , Humans
8.
Vox Sang ; 118(7): 533-542, 2023 Jul.
Article in English | MEDLINE | ID: mdl-37246454

ABSTRACT

BACKGROUND AND OBJECTIVES: Polyvinyl chloride (PVC) plasticized with di(2-ethylhexyl) phthalate (DEHP) is a widely used material for medical transfusion devices. Not covalently bound to PVC, DEHP can migrate into blood products during storage. Recognized as an endocrine disruptor and raising concerns about its potential carcinogenicity and reprotoxicity, DEHP is gradually being withdrawn from the medical device market. Therefore, the use of alternative plasticizers, such as diisononylcyclohexane-1,2-dicarboxylate (DINCH) and di(2-ethylhexyl) terephthalate (DEHT), as potential candidates for the replacement of DEHP in medical transfusion devices has been investigated. The purpose of this study was to evaluate the quantity of PVC-plasticizers in the blood components according to their preparation, storage conditions and in function of the plasticizer. MATERIALS AND METHODS: Whole blood was collected, and labile blood products (LBPs) were prepared by the buffy-coat method with a PVC blood bag plasticized either with DEHP, DINCH or DEHT. DINCH and DEHT equivalent concentrations were quantified in LBPs by liquid chromatography-tandem mass spectrometry or coupled with UV and compared to DEHP equivalent concentrations. RESULTS: The plasticizer equivalent concentration to which a patient is exposed during a transfusion depends on the preparation of LBPs as well as their storage conditions, that is, temperature and storage time. At day 1, for all LBPs, the migration of DEHP is 5.0 and 8.5 times greater than DINCH and DEHT, respectively. At the end of the 49 days storage period, the DEHP equivalent concentration in red blood cells concentrate is statistically higher when compared to DINCH and DEHT, with maximal values of 1.85, 1.13 and 0.86 µg/dm2 /mL, respectively. CONCLUSION: In addition to lower toxicity, transfused patients using PVC-DEHT or PVC-DINCH blood bags are less exposed to plasticizers than using PVC-DEHP bags with a ranging exposure reduction from 38.9% to 87.3%, due to lower leachability into blood components.


Subject(s)
Blood Preservation , Cyclohexanecarboxylic Acids , Diethylhexyl Phthalate , Phthalic Acids , Plasticizers , Humans , Diethylhexyl Phthalate/analysis , Plasticizers/analysis , Polyvinyl Chloride/chemistry , Blood Preservation/instrumentation , Blood Preservation/standards , Blood Safety , Blood Transfusion/instrumentation , Blood Transfusion/standards , Cyclohexanecarboxylic Acids/analysis , Chromatography, High Pressure Liquid
9.
J Infect Chemother ; 29(12): 1160-1163, 2023 Dec.
Article in English | MEDLINE | ID: mdl-37543174

ABSTRACT

Here, we describe a rare case of malignant lymphoma after liver transplantation for liver cirrhosis caused by human immunodeficiency virus (HIV) and hepatitis C virus (HCV) co-infection. A male patient was diagnosed with hemophilia A at 8 months of age. Since then, he had been receiving blood products, which led to HIV and HCV co-infection. His HIV viral load was suppressed with antiretroviral therapy, and a sustained virologic response was achieved for HCV using direct-acting antivirals. However, his decompensated liver cirrhosis progressed, and deceased donor liver transplantation was performed. A post-transplant lymphoproliferative disorder (PTLD) developed 105 days after liver transplantation, with enlarged para-aortic and hilar lymph nodes, a right renal mass, and masses in the small and large intestines. Histopathological examination confirmed monomorphic PTLD (diffuse large B-cell lymphoma). Against the treatment (reduction of immunosuppression, rituximab, and chemotherapy), the response was poor, and the patient died 94 days after the outbreak of PTLD. Both transplantation and HIV infection are risk factors for lymphoproliferative diseases. To the best of our knowledge, this is one of the very few reports of PTLD in a patient with HIV/HCV co-infection.

10.
Pediatr Cardiol ; 44(1): 218-227, 2023 Jan.
Article in English | MEDLINE | ID: mdl-35963890

ABSTRACT

The number of adults with congenital heart disease (CHD) requiring cardiovascular (CV) surgery is increasing rapidly in today's era. We hypothesized that exposure to perioperative blood products is associated with worse outcomes in adults. All adults (≥ 18 years old) undergoing CV surgery with Cardio-Pulmonary Bypass (CPB) between 2015 and 2020 were reviewed retrospectively. Associations between transfusion and outcomes were studied by univariable logistic regression and Wilcoxon rank sum tests. Cox/ logistic regression was used to assess (a) postoperative ventilation time and length of stay, and (b) major complications, respectively. Of 323 patients, 170 (53%) received blood products perioperatively. The median age was 27 (interquartile range [IQR]: 22-36) years, there were 181 (46%) males, and 16 (5%) patients had single ventricle anatomy. Patients receiving products experienced more complications (OR: 6.6, 95% CI: [2.9, 14.7], p < 0.001) specifically, cardiac arrest (OR: 8.8, 95% CI: [1.1, 71.9], p = 0.04). Transfusion was associated with greater frequency of thrombosis ((OR: 7.8, 95% CI: [1.8, 34.7], p = 0.01)), longer ventilation time (HR: 3.0, 95% CI: [2.4, 3.9], p < 0.001), and longer hospital length of stay (HR: 2.7, 95% CI: [2.1, 3.4], p < 0.001). Longer CPB time (OR: 1.0, 95% CI: [1.0, 1.1], p < 0.001) and prior cardiac surgery (OR: 1.6, 95% CI: [1.3, 2.1], p < 0.001) were independent predictors of perioperative blood product transfusion. Adults who received perioperative blood products experienced more complications and worse in-hospital outcomes. Future research on optimizing blood product transfusion based on risk prediction is needed to optimize outcomes in adults with CHD.


Subject(s)
Cardiac Surgical Procedures , Heart Defects, Congenital , Male , Humans , Adult , Young Adult , Adolescent , Female , Retrospective Studies , Cardiac Surgical Procedures/adverse effects , Heart Defects, Congenital/surgery , Heart Defects, Congenital/complications , Blood Transfusion , Cardiopulmonary Bypass/adverse effects , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Risk Factors
11.
Cardiol Young ; 33(5): 726-732, 2023 May.
Article in English | MEDLINE | ID: mdl-35638699

ABSTRACT

PURPOSE: Systemic-to-pulmonary shunts are used as a source of pulmonary blood flow in palliated Congenital Heart Disease in neonates and young infants. Shunt thrombosis, often requiring shunt interventions during index hospitalisation, is associated with poor outcomes. We hypothesised that extensive use of perioperative pro-coagulant products may be associated with shunt thrombosis. METHODS: Children (≤18 years) undergoing systemic-to-pulmonary shunts with in-hospital shunt reinterventions between 2016 and 2020 were reviewed retrospectively. Perioperative associations to shunt thrombosis were examined by univariate logistic regression and Wilcoxon rank sum tests as appropriate. Cox and log transformed linear regression were used to analyse postoperative ventilation duration, length of stay, and cost. RESULTS: Of 71 patients requiring in-hospital shunt intervention after systemic-to-pulmonary shunts, 10 (14%) had acute shunt thrombosis, and among them five (50%) died. The median age was four (interquartile range: 0-15) months. There were 40 (56%) males, 41 (58%) had single ventricle anatomy, and 29 (40%) were on preoperative anticoagulants. Patients with acute shunt thrombosis received greater volume of platelets (p = 0.04), cryoprecipitate (p = 0.02), and plasma (p = 0.04) postoperatively in the ICU; experienced more complications (p = 0.01) including re-exploration for bleeding (p = 0.008) and death (p = 0.02), had longer hospital length of stays (p = 0.004), greater frequency of other arterial/venous thrombosis (p = 0.02), and greater hospital costs (p = 0.002). CONCLUSIONS: Patients who develop acute shunt thrombosis receive more blood products perioperatively and experience worse hospital outcomes and higher hospital costs. Future research on prevention/early detection of shunt thrombosis is needed to improve outcomes in infants after systemic-to-pulmonary shunt surgery.


Subject(s)
Heart Defects, Congenital , Thrombosis , Infant , Infant, Newborn , Male , Humans , Child , Female , Retrospective Studies , Treatment Outcome , Lung , Heart Defects, Congenital/surgery , Thrombosis/etiology
12.
Medicina (Kaunas) ; 59(2)2023 Jan 23.
Article in English | MEDLINE | ID: mdl-36837421

ABSTRACT

Background and Objectives: Patients undergoing liver transplantation (LT) often require increased blood product transfusion due to pre-existing coagulopathy and intraoperative fibrinolysis. Strategies to minimise intraoperative bleeding and subsequent blood product requirements include platelet transfusion and tranexamic acid (TXA). Prophylactic TXA administration has been shown to reduce bleeding and blood product requirements intraoperatively. However, its clinical use is still debated. The aim of this study was to report on a single-centre practice and analyse clinical characteristics and outcomes of LT recipients according to intraoperative treatment of TXA or platelet transfusion. Materials and Methods: This was a retrospective observational cohort study in which we reviewed 162 patients' records. Characteristics, intraoperative requirement of blood products, postoperative development of thrombosis and outcomes were compared between patients without or with intraoperative TXA treatment and without or with platelet transfusion. Results: Intraoperative treatment of TXA and platelets was 53% and 57.40%, respectively. Patients who required intraoperative administration of TXA or platelet transfusion also required more transfusion of blood products. Neither TXA nor platelet transfusion were associated with increased postoperative development of hepatic artery and portal vein thrombosis, 90-day mortality or graft loss. There was a significant increase in the median length of intensive care unit (ICU) stay in those who received platelet transfusion only (2.00 vs. 3.00 days; p = 0.021). Time to extubate was significantly different in both those who required TXA and platelet transfusion intraoperatively. Conclusions: Our analysis indicates that LT recipients still required copious intraoperative transfusion of blood products, despite the use of intraoperative TXA and platelets. Our findings have important implications for current transfusion practice in LT recipients and may guide clinicians to act upon these findings, which will support global efforts to encourage a wider use of TXA to reduce transfusion requirements, including platelets.


Subject(s)
Antifibrinolytic Agents , Liver Transplantation , Thrombosis , Tranexamic Acid , Humans , Antifibrinolytic Agents/therapeutic use , Blood Loss, Surgical/prevention & control , Cohort Studies , Platelet Transfusion , Retrospective Studies , Tranexamic Acid/therapeutic use , Treatment Outcome
13.
Transfusion ; 62(12): 2525-2538, 2022 12.
Article in English | MEDLINE | ID: mdl-36285763

ABSTRACT

BACKGROUND: Equitable allocation of scarce blood products needed for a randomized controlled trial (RCT) is a complex decision-making process within the blood supply chain. Strategies to improve resource allocation in this setting are lacking. METHODS: We designed a custom-made, computerized system to manage the inventory and allocation of COVID-19 convalescent plasma (CCP) in a multi-site RCT, CONCOR-1. A hub-and-spoke distribution model enabled real-time inventory monitoring and assignment for randomization. A live CCP inventory system using REDCap was programmed for spoke sites to reserve, assign, and order CCP from hospital hubs. A data-driven mixed-integer programming model with supply and demand forecasting was developed to guide the equitable allocation of CCP at hubs across Canada (excluding Québec). RESULTS: 18/38 hospital study sites were hubs with a median of 2 spoke sites per hub. A total of 394.5 500-ml doses of CCP were distributed; 349.5 (88.6%) doses were transfused; 9.5 (2.4%) were wasted due to mechanical damage sustained to the blood bags; 35.5 (9.0%) were unused at the end of the trial. Due to supply shortages, 53/394.5 (13.4%) doses were imported from Héma-Québec to Canadian Blood Services (CBS), and 125 (31.7%) were transferred between CBS regional distribution centers to meet demand. 137/349.5 (39.2%) and 212.5 (60.8%) doses were transfused at hubs and spoke sites, respectively. The mean percentages of total unmet demand were similar across the hubs, indicating equitable allocation, using our model. CONCLUSION: Computerized tools can provide efficient and immediate solutions for equitable allocation decisions of scarce blood products in RCTs.


Subject(s)
COVID-19 , Humans , COVID-19/therapy , Canada , Quebec
14.
Transfusion ; 62(10): 2057-2067, 2022 10.
Article in English | MEDLINE | ID: mdl-35986654

ABSTRACT

BACKGROUND: Unanticipated transfusion requirements during liver transplantation can delay lifesaving intraoperative resuscitation and strain blood bank resources. Risk-stratified preoperative blood preparation can mitigate these deleterious outcomes. STUDY DESIGN AND METHODS: A two-tiered blood preparation protocol for liver transplantation was retrospectively evaluated. Eleven binary variables served as criteria for high-risk (HR) allocation. Primary outcomes included red blood cell (RBC), plasma (FFP), and platelet (Plt) utilization. Secondary outcomes included product under- and overpreparation. Contingency tables for transfusion requirements above the population means were generated using 15 clinical variables. Modified protocols were developed and retrospectively optimized using the study population. RESULTS: Of 225 recipients, 102 received HR preoperative orders, which correlated to higher intraoperative transfusion requirements. However, univariate analysis identified only two statistical risk factors per product: Hgb ≤7.8 g/dl (p < .001) and MELD ≥38 (p = .035) for RBCs, Hgb ≤7.8 g/dl (p = .002) and acute alcoholic hepatitis (p = 0.015) for FFP, and Hgb ≤7.8 g/dl (p = .001) and normothermic liver preservation (p = .037) for Plts. Based on these findings, we developed modified protocols for individual products, which were evaluated retrospectively for their effectiveness at reducing under-preparatory events while limiting product overpreparation. Cohort statistics were used to define the preparation strategy for each protocol. Retrospective comparative analysis demonstrated the superiority of the modified protocols by improving the under-preparation rate from 24% to <10% for each product, which required a 1.56-fold and 1.44-fold increase in RBC and FFP overpreparation, respectively. Importantly, there was no difference in Plt overpreparation. DISCUSSION: We report translatable data-driven blood bank preparation protocols for liver transplantation.


Subject(s)
Liver Transplantation , Blood Transfusion , Erythrocyte Transfusion/methods , Humans , Liver Transplantation/methods , Plasma , Retrospective Studies
15.
Clin Trials ; 19(2): 137-145, 2022 04.
Article in English | MEDLINE | ID: mdl-35229691

ABSTRACT

BACKGROUND: Success in conducting clinical trials during the coronavirus disease of 2019 pandemic requires the ability to innovate and adapt. There are well-established procedures for the blinding of investigational agents, especially medications, in placebo-controlled randomized clinical trials within the Veterans Health Administration. However, these procedures, managed by research pharmacists, may not apply to investigational agents that are not exclusively managed by pharmacy, such as blood products, including coronavirus disease of 2019 convalescent plasma (plasma). In the absence of established blinding procedures, such studies require special design considerations to minimize uncertainty or bias. METHODS: We describe the processes and procedures developed for blinding of plasma in "Veterans Affairs CoronavirUs Research and Efficacy Studies-1" as a prototypical study using this class of investigational therapeutic agents. Veterans Affairs CoronavirUs Research and Efficacy Studies-1 is an ongoing multicenter randomized clinical trial testing the efficacy of plasma added to conventional therapy for severe acute respiratory syndrome coronavirus-2 infection. RESULTS: We report the design of procedures to supply investigational blood products or 0.9% normal saline (saline) control while ensuring the integrity of the blind. Key aspects include workflow considerations, physical blinding strategies, and methods for engaging stakeholders. These procedures leverage the well-established Veterans Affairs research pharmacist's research infrastructure, and Blood Bank Services, which is responsible for blood-based investigational products. CONCLUSION: By describing the methods used to deliver blood products in a blinded manner in Veterans Affairs CoronavirUs Research and Efficacy Studies-1, we strive both to educate and to increase awareness to improve the implementation of these biological therapeutics for future, high-quality research studies.


Subject(s)
COVID-19 , Veterans , COVID-19/therapy , Humans , Immunization, Passive , Pandemics , Pharmaceutical Preparations , SARS-CoV-2 , Treatment Outcome , COVID-19 Serotherapy
16.
J Extra Corpor Technol ; 54(1): 35-41, 2022 Mar.
Article in English | MEDLINE | ID: mdl-36380821

ABSTRACT

Blood product usage is an important outcome for patients undergoing cardiac surgery. In 2015, our center made a concerted effort with multiple departments to focus on reducing transfusion rates in surgical patients requiring cardiopulmonary bypass (CPB). Specific changes included an upgrade of the oxygenator in mid-2015 and, in early 2016, implementation of a hemostasis management system (HMS) that used heparin dose-response titration assays for heparin and protamine management. A retrospective chart review demonstrated significant decreases in the quarterly average of patients receiving packed red blood cells (PRBCs) from a baseline of 26.7% to 22.7% following the oxygenator upgrade (p = .021) and from 22.7% to 8.8% following implementation of the HMS (p = .0017). Platelet usage decreased from an average of 50.5% during the baseline and oxygenator upgrade periods to 22.2% following implementation of the HMS (p < .0001). Usage of fresh frozen plasma (FFP) decreased from an average of 28.2% of cases during the baseline and oxygenator upgrade periods to 10.4% during 2016, and cryoprecipitate usage decreased from 38.5% to 15.4%. Heparin usage averaged 56,903 units before implementation of the HMS, decreasing to an average of 43,796 units following HMS implementation (p < .0001). During the same time periods, protamine usage averaged 340.3 mg and 183.2 mg, respectively. Because improvements achieved during quality initiatives may revert back to their pre-intervention state once the assessment period is over, we performed a second retrospective analysis to determine whether the improvements achieved were maintained during the 48 months following the initial study. During 2017-2020, quarterly average usage of blood products was as follows: PRBCs, 11.9%; platelets, 14.7%; FFP, 6.2%; and cryoprecipitate, 11.5%. Quarterly, average use of heparin and protamine were 31,556 ± 2,757 units and 189 ± 113 mg, respectively. These findings indicate that the improvements achieved were not limited to the duration of the initial quality initiative.


Subject(s)
Cardiac Surgical Procedures , Humans , Retrospective Studies , Tertiary Care Centers , Cardiac Surgical Procedures/methods , Cardiopulmonary Bypass/methods , Heparin/therapeutic use , Protamines/therapeutic use
17.
Clin Microbiol Rev ; 33(4)2020 09 16.
Article in English | MEDLINE | ID: mdl-32792417

ABSTRACT

Convalescent plasma (CP) therapy has been used since the early 1900s to treat emerging infectious diseases; its efficacy was later associated with the evidence that polyclonal neutralizing antibodies can reduce the duration of viremia. Recent large outbreaks of viral diseases for which effective antivirals or vaccines are still lacking has renewed the interest in CP as a life-saving treatment. The ongoing COVID-19 pandemic has led to the scaling up of CP therapy to unprecedented levels. Compared with historical usage, pathogen reduction technologies have now added an extra layer of safety to the use of CP, and new manufacturing approaches are being explored. This review summarizes historical settings of application, with a focus on betacoronaviruses, and surveys current approaches for donor selection and CP collection, pooling technologies, pathogen inactivation systems, and banking of CP. We additionally list the ongoing registered clinical trials for CP throughout the world and discuss the trial results published thus far.


Subject(s)
Coronavirus Infections/therapy , Pneumonia, Viral/therapy , Antibodies, Neutralizing/analysis , Biological Specimen Banks/standards , COVID-19 , Donor Selection/methods , Donor Selection/standards , Enzyme-Linked Immunosorbent Assay , Humans , Immunization, Passive/adverse effects , Immunization, Passive/standards , Neutralization Tests/standards , Pandemics , Severe Acute Respiratory Syndrome/therapy , COVID-19 Serotherapy
18.
Transfusion ; 61(5): 1578-1585, 2021 05.
Article in English | MEDLINE | ID: mdl-33728705

ABSTRACT

BACKGROUND: Cryoprecipitate has a short post-thaw expiry time of 6 h. The aim of this study was to assess the stability and function of cryoprecipitate components (FVIII, fibrinogen, vWF, and FXIII) and cryoprecipitate sterility up to 120 h post-thawing when stored at two temperatures (2-6°C and room temperature [20-24°C]). METHODS AND MATERIALS: Twenty batches (110 individual units) of time-expired, thawed cryoprecipitate were collected. Units were sampled at the 6-h expiration mark and then stored at 2-6°C or room temperature (RT). They were resampled every 24 h for 120 h. One unit from each batch was sent for sterility testing at 120 h. Samples had FVIII (one stage and chromogenic), fibrinogen, FXIII, vWFag, and vWF:RCo assays performed in batches. Rotational thromboelastometry (ROTEM) was also performed. RESULTS: FVIII levels declined significantly at 120 h post-thawing at both RT and 2-6°C, but still met international standards for FVIII content. Fibrinogen, vWF antigen, and FXIII levels reduced minimally over 120 h and always met international standard requirements when stored at either temperature. ROTEM analysis demonstrated that fibrinogen function was not compromised at 120 h post-thawing under both storage conditions. vWF:RCo levels declined significantly over 120 h at both storage temperatures. No bacterial contamination was detected in 20 units of cryoprecipitate following storage for 120 h post-thawing. CONCLUSION: These results demonstrate that extension of the storage time of thawed cryoprecipitate to 120 h, stored at either 2-6°C or RT, is feasible while still maintaining required FVIII, fibrinogen, and vWFag levels. Storage at 2-6°C has the advantage of reduced risk of potential bacterial contamination.


Subject(s)
Factor VIII/chemistry , Fibrinogen/chemistry , Blood Preservation/methods , Cryopreservation/methods , Factor VIII/analysis , Factor XIII/analysis , Fibrinogen/analysis , Humans , Temperature , Thrombelastography , Time Factors , von Willebrand Factor/analysis
19.
Surg Today ; 51(4): 582-588, 2021 Apr.
Article in English | MEDLINE | ID: mdl-33037476

ABSTRACT

PURPOSE: Anatomical pulmonary resection, such as lobectomy, is a common procedure. Staplers play an important role in dividing an incomplete interlobular fissure, especially in thoracoscopic surgery. This study evaluates the effectiveness of a powered stapler for reducing the need for intraoperative fibrin glue and the incidence of air leakage after radical pulmonary resection. METHODS: The subjects of this retrospective study were 478 patients who underwent radical pulmonary resection. Propensity score analysis generated two matched pairs of 177 patients treated using powered and manual staplers, respectively. RESULTS: The need for fibrin glue intraoperatively during radical pulmonary resection was significantly less in the powered-stapler group (47.5%) than in the manual-stapler group (58.8%, p = 0.033). The incidence of postoperative air leakage following radical pulmonary resection was also significantly lower in the powered-stapler group (2.8%) than in the manual-stapler group (10.7%, p = 0.003). Logistic regression analysis identified use of the powered stapler as a factor independently associated with both non-use of fibrin glue intraoperatively (odds ratio, 0.63; p = 0.040) and no postoperative air leakage (odds ratio, 0.26; p = 0.010). CONCLUSION: Using a powered stapler to divide the incomplete interlobular fissure decreased the need for additional intraoperative management using fibrin glue and reduced postoperative air leakage in radical pulmonary resection.


Subject(s)
Anastomotic Leak/prevention & control , Pneumonectomy/instrumentation , Postoperative Complications/prevention & control , Propensity Score , Surgical Staplers , Air , Anastomotic Leak/epidemiology , Drug Utilization/statistics & numerical data , Electric Power Supplies , Female , Fibrin Tissue Adhesive , Humans , Incidence , Intraoperative Care/statistics & numerical data , Male , Pneumonectomy/methods , Postoperative Complications/epidemiology , Retrospective Studies , Thoracoscopy/instrumentation , Thoracoscopy/methods
20.
Int J Mol Sci ; 22(8)2021 Apr 11.
Article in English | MEDLINE | ID: mdl-33920459

ABSTRACT

While differences among donors has long challenged meeting quality standards for the production of blood components for transfusion, only recently has the molecular basis for many of these differences become understood. This review article will examine our current understanding of the molecular differences that impact the quality of red blood cells (RBC), platelets, and plasma components. Factors affecting RBC quality include cytoskeletal elements and membrane proteins associated with the oxidative response as well as known enzyme polymorphisms and hemoglobin variants. Donor age and health status may also be important. Platelet quality is impacted by variables that are less well understood, but that include platelet storage sensitive metabolic parameters, responsiveness to agonists accumulating in storage containers and factors affecting the maintenance of pH. An increased understanding of these variables can be used to improve the quality of blood components for transfusion by using donor management algorithms based on a donors individual molecular and genetic profile.


Subject(s)
Blood Donors , Blood Platelets , Blood Preservation , Erythrocytes , Age Factors , Humans
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