Association between serum ferritin level and lipid profile among diabetic patients: A retrospective cohort study.

High serum ferritin (SF) levels have been linked to obesity, metabolic syndrome, atherosclerosis, diabetes, dyslipidemia, and cancer. This study aimed to investigate the association between SF and dyslipidemia in adults diagnosed with diabetes mellitus. This cross-sectional study retrospectively analyzed the electronic medical records of eligible patients from 3 primary locations in Saudi Arabia namely - Abha, Khamis Mushyt, and Jeddah - from 2010 to 2020. The study included adult patients aged 18 years or older who were diagnosed with diabetes mellitus and identified with an HbA1c level of ≥6.5. This study involved 3674 participants, with males accounting for 26.6% of the total. The mean age of the studied population was 48.0 ±â€…18.4 years. The median [interquartile range] of SF among males was higher than females, however, this difference was not statistically significant (60.0 [23.4-125.8] vs 55.4 [24.0-113.4], P = 0.204). On the other hand, age and region were significantly associated with SF (P = .032 and 0.035). SF had a significant positive correlation with cholesterol (r = 0.081, P < .001), low-density lipoprotein cholesterol (r = .087, P < .001), and triglycerides (r = 0.068, P < .001) and negative correlation with high-density lipoprotein cholesterol (r = -0.13, P < .001). Multivariate analysis revealed that age, sex, residence, and HbA1c were significantly affecting the lipid profile. Clinicians should consider including SF testing as part of the comprehensive evaluation of patients with diabetes and dyslipidemia.

Lipid profiles and their relation to glycemic control in Saudi Arabia: The role of altitudes and environmental factor.

Background: The height from sea levels, environmental factors, human-environment interactions, and lifestyle significantly influence the lipid profile and glycemic control of a population. Objective: This study aims to explore the influence of altitude on lipid profiles and glycemic control among the Saudi population at sea level and high altitude. Methods: In this retrospective cross-sectional study, a large dataset of patients of both gender and over 30 years old attending internal medicine clinics from two different regions at different heights from sea level, Jeddah (sea level) and Asir region (high altitudes) and referred to commercial laboratories for glycated haemoglobin (HbA1c) and lipids profile. Results: Compared to the Asir region, the Jeddah region had significantly higher mean values for fasting blood sugar (FBG), total cholesterol (TC), low-density lipoprotein (LDL-C), and triglycerides (TG) (P < 0.05). Every 1 mg/dL increase in FBG results in a 0.662 mg/dL increase in TG from the Jeddah region. However, it was a 0.318 mg/dL increase in TG from the Asir region. HbA1c demonstrated a significant (P < 0.05) strong positive correlation with TC, low-density lipoprotein cholesterol (LDL-C), triglycerides (TG), and lipid ratio. FBG levels were also associated with a high level of TC/HDL-C (ß = 0.137 95% confidence interval [CI]: 0.11-0.21; P < 0.05), LDL-C/high-density lipoprotein cholesterol (HDL-C) (ß = 0.50; 95% CI: 0.31-1.49; P < 0.05), and TG/HDL-C (ß = 0.14; 95% CI = 0.12-0.15; P < 0.05) in Jeddah region. However, significantly high blood pressure was observed in the population from high altitudes. Conclusion: Our results demonstrated a significant positive correlation between lipid profile and glycemic control with high prevalence at sea level.

Association between serum uric acid with diabetes and other biochemical markers.

Objective: This study aimed to decipher the association between serum uric acid (UA) and glycated hemoglobin (HbA1c) in the population from the southern region of Saudi Arabia. Method: In this retrospective cross-sectional investigation, clinical data obtained from the different commercial laboratories in the Asir region of Saudi Arabia were screened over 2 years. Data were analyzed using standard statistical methods. Results: A total of 1984 laboratory investigations with 1215 females (61.2%) and 769 males (38.6%) were included in the data analysis. In our investigation, the prevalence of hyperuricemia in the study population was 53.5% (41.2% females and 12.3% males) and in the diabetic population was 12.7% (9.47% females and 3.23% males), in prediabetics was 12.65% (9.8% females and 2.85% males), respectively. Prediabetic subjects had higher UA levels than people with diabetes or healthy people. Higher UA quartiles were associated with a high level of urea, blood urea nitrogen (BUN) creatinine, HbA1c, fasting blood sugar (FBS), and total cholesterol (TC) (P < 0.05). High UA (OR = 1.33 for diabetes; OR = 2.676 for prediabetes), high BUN (OR = 3.05 for diabetes; OR = 2.293 for prediabetes), high TC (OR = 3.75 for diabetes; OR = 1.098 for prediabetes), and high TG (OR = 2.67 for diabetes; OR = 1.943 for prediabetes) parameters are the most influential risk factor in diabetic and prediabetic patients than the people who have normal UA, BUN, TC, and TG value. Conclusion: High UA levels are significantly associated with prediabetes as defined by HbA1c criteria, indicating that UA has a significant role in the disturbance of glucose metabolism. A significant positive association was observed between dyslipidemia and serum UA in the study population.

Prediction of COVID-19 severity from clinical and biochemical markers: a single-center study from Saudi Arabia.

OBJECTIVE: It is known that the severity of COVID-19 is linked to the prognosis of patients; therefore, an early identification is required for patients who are likely to develop severe or critical COVID-19 disease. The purpose of this study is to propose a statistical method for identifying the severity of COVID-19 disease by using clinical and biochemical laboratory markers. PATIENTS AND METHODS: A total of 48 clinically and laboratory-confirmed cases of COVID-19 were obtained from King Fahad Hospital, Medina (KFHM) between 27th April 2020 to 25th May 2020. The patients' demographics and severity of COVID-19 disease were assessed using 39 clinical and biochemical features. After excluding the demographics, 35 predicting features were included in the analysis (diabetes, chronic disease, viral and bacterial co-infections, PCR cycle number, ICU admission, clot formation, cardiac enzymes elevation, hematology profile, sugar levels in the blood, as well as liver and kidney tests, etc.). Logistic regression, stepwise logistic regression, L-2 logistic regression, L-2 stepwise logistic regression, and L-2 best subset logistic regression were applied to model the features. The consistency index was used with kernel Support-Vector Machines (SVM) for the identification of associated markers. RESULTS: L-2 best subset logistic regression technique outperformed all other fitted models for modeling COVID-19 disease severity by achieving an accuracy of 88% over the test data. Consistency index over L-2 best subset logistic regression identified 14 associated markers that can best predict the COVID-19 severity among COVID-19 patients. CONCLUSIONS: By combining a variety of laboratory markers with L-2 best subset logistic regression, the current study has proposed a highly accurate and clinically interpretable model of predicting COVID-19 severity.

Prevalence and Characteristics of Thyroid Abnormalities and Its Association with Anemia in ASIR Region of Saudi Arabia: A Cross-Sectional Study.

The thyroid gland plays a significant role in the metabolism and proliferation of blood cells; hematological disorders are frequently observed in patients with thyroid disorders, and the most frequent problem is anemia. The main objective of this research work is to evaluate the prevalence and types of thyroid dysfunction and their association with anemia in different gender stratified by age in the Asir region of Saudi Arabia. Four years of data from July 2016 to July 2020 for 9992 study subjects were collected. Statistical analysis was performed based on thyroid disorder and anemia stratified by gender and age subgroup. The mean age of the study subject was 43.4 ± 15.8 years, and females constituted 61.7% of cases. Thyroid dysfunction was observed in 49.76% (4973), and subclinical hypothyroidism was the most prevalent type (3922/9992), followed by primary hypothyroidism (530/9992). Females have a significantly higher overall prevalence of thyroid dysfunction than males (p < 0.05). Anemia was detected in 1344 females and 465 males with a thyroid disorder, and also, the prevalence was significantly higher (p < 0.05), compared to the normal thyroid group. Thyroid disorders are a common problem in our population, more prevalent in females than males, with the peak age of above 30 years, and are associated with an increased prevalence of anemia.

Ultramicrosurgery: A new approach to treat primary male genital lymphedema.

BACKGROUND: Lymphedema is a chronic pathology characterized by progressive swelling due to lymphatic dysfunction (1). Literature contains few studies that focus on male genital lymphedema. A variety of surgical techniques as part of the male genital lymphedema therapeutic strategy has been described. Supramicrosurgical lymphatico-venular anastomosis s-LVA, based on connecting lymphatic collectors to venules, has evidenced efficient outcomes thus far. However, the peculiarity of the genital area may lead to an innovative and even more accurate surgical technique as a treatment of male genital lymphedema: lymphatic pre-collectors located superficially over the fascial layer can be used to perform the ultramicrosurgical anastomosis. PURPOSE OF THE STUDY: In this paper, the authors report their experience of this new surgical concept based on anastomosing lymphatic precollectors to venules. METHODS: We performed a retrospective study from 2014 to 2016. Six male patients with primary genital lymphedema underwent ultramicrosurgical lymphatico-venular anastomosis in Siena University Hospital, Italy. RESULTS: Ultramicrosurgical lymphatico-venular anastomosis has evidenced positive outcomes in terms of prognosis, infectious complications, volume reduction, and quality of life. The average cellulitis rate dropped from 2.5 episodes a year to 0.5 episodes after surgical intervention. The mean satisfaction index passed from 1.33 before the intervention to 2.83. CONCLUSION: Ultramicrosurgical lymphatico-venular anastomosis represents a challenging physiological approach for male genital lymphedema with promising outcomes.

Do Tanzanian hospitals need healthcare ethics committees? report on the 2014 dartmouth/penn research ethics training and program development for tanzania (DPRET) workshop

Ethical issues are common in the global community. The shortage of human and medical resources when working with vulnerable populations requires institutional support to address the challenges that often arise in the patient-provider relationship. The 2014 Dartmouth/Penn Research Ethics Training and Program Development for Tanzania (DPRET) workshop centred on discussions about research and clinical ethics issues unique to Tanzanian healthcare providers. This article discusses some of the ethical challenges that workshop participants reported in their day-to-day work life with patients and families, such as truth-telling, disagreements over treatment plans and patient distrust of local physicians and hospital staff, among others. The Tanzanian participants recognised the need for supportive mechanisms within their local hospital environments. Further dialogue and research on the development ofinstitutional ethics committees within hospital systems is critically needed so that healthcare providers can meet their ethical and professional obligations to patients and families and address ethical conflicts that arise in a timely and productive fashion

Low circulating protein C levels are associated with lower leg ulcers in patients with diabetes.

Activated protein C (APC) promotes angiogenesis and reepithelialisation and accelerates healing of diabetic ulcers. The aim of this study was to determine the relationship between the incidence of lower leg ulcers and plasma levels of APC's precursor, protein C (PC), in diabetic patients. Patients with diabetes who had a lower leg ulcer(s) for >6 months (n = 36) were compared with age-, type of diabetes-, and sex-matched subjects with diabetes but without an ulcer (n = 36, controls). Total PC was assessed using a routine PC colorimetric assay. There was a significantly (P < 0.001) lower level of plasma PC in patients with ulcers (103.3 ± 22.7, mean ± SD) compared with control (127.1 ± 34.0) subjects, when corrected for age and matched for gender and type of diabetes. Ulcer type (neuropathic, ischaemic, or mixed) was not a significant covariate for plasma PC levels (P = 0.35). There was no correlation between PC levels and gender, type of diabetes, HbA1c, or C-reactive protein in either group. In summary, decreased circulating PC levels are associated with, and may predispose to, lower leg ulceration in patients with diabetes.

Management of a suspicious adnexal mass: a clinical practice guideline.

QUESTIONS: What is the optimal strategy for preoperative identification of the adnexal mass suspicious for ovarian cancer? What is the most appropriate surgical procedure for a woman who presents with an adnexal mass suspicious for malignancy? PERSPECTIVES: In Canada in 2010, 2600 new cases of ovarian cancer were estimated to have been diagnosed, and of those patients, 1750 were estimated to have died, making ovarian cancer the 7th most prevalent form of cancer and the 5th leading cause of cancer death in Canadian women. Women with ovarian cancer typically have subtle, nonspecific symptoms such as abdominal pain, bloating, changes in bowel frequency, and urinary or pelvic symptoms, making early detection difficult. Thus, most ovarian cancer cases are diagnosed at an advanced stage, when the cancer has spread outside the pelvis. Because of late diagnosis, the 5-year relative survival ratio for ovarian cancer in Canada is only 40%. Unfortunately, because of the low positive predictive value of potential screening tests (cancer antigen 125 and ultrasonography), there is currently no screening strategy for ovarian cancer. The purpose of this document is to identify evidence that would inform optimal recommended protocols for the identification and surgical management of adnexal masses suspicious for malignancy. OUTCOMES: Outcomes of interest for the identification question included sensitivity and specificity. Outcomes of interest for the surgical question included optimal surgery, overall survival, progression-free or disease-free survival, reduction in the number of surgeries, morbidity, adverse events, and quality of life. METHODOLOGY: After a systematic review, a practice guideline containing clinical recommendations relevant to patients in Ontario was drafted. The practice guideline was reviewed and approved by the Gynecology Disease Site Group and the Report Approval Panel of the Program in Evidence-based Care. External review by Ontario practitioners was obtained through a survey, the results of which were incorporated into the practice guideline. PRACTICE GUIDELINE: These recommendations apply to adult women presenting with a suspicious adnexal mass, either symptomatic or asymptomatic. IDENTIFICATION OF AN ADNEXAL MASS SUSPICIOUS FOR OVARIAN CANCER: Sonography (particularly 3-dimensional sonography), magnetic resonance imaging (mri), and computed tomography (ct) imaging are each recommended for differentiating malignant from benign ovarian masses. However, the working group offers the following further recommendations, based on their expert consensus opinion and a consideration of availability, access, and harm: Where technically feasible, transvaginal sonography should be the modality of first choice in patients with a suspicious isolated ovarian mass.To help clarify malignant potential in patients in whom ultrasonography may be unreliable, mri is the most appropriate test.In cases in which extra-ovarian disease is suspected or needs to be ruled out, ct is the most useful technique.Evaluation of an adnexal mass by Doppler technology alone is not recommended. Doppler technology should be combined with a morphology assessment.Ultrasonography-based morphology scoring systems can be used to differentiate benign from malignant adnexal masses. These scoring systems are based on specific ultrasound parameters, each with several scores base on determined features. All evaluated scoring systems were found to have an acceptable level of sensitivity and specificity; the choice of scoring system may therefore be made based on clinician preference.As a standalone modality, serum cancer antigen 125 is not recommended for distinguishing between benign and malignant adnexal masses.Frozen sections for the intraoperative diagnosis of a suspicious adnexal mass is recommended in settings in which availability and patient preference allow. SURGICAL PROCEDURES FOR AN ADNEXAL MASS SUSPICIOUS FOR MALIGNANCY: To improve survival, comprehensive surgical staging with lymphadenectomy is recommended for the surgical management of patients with early-stage ovarian cancer. Laparoscopy is a reasonable alternative to laparotomy, provided that appropriate surgery and staging can be done. The choice between laparoscopy and laparotomy should be based on patient and clinician preference. Discussion with a gynecologic oncologist is recommended. Fertility-preserving surgery is an acceptable alternative to more extensive surgery in patients with low-malignant-potential tumours and those with well-differentiated surgical stage i ovarian cancer. Discussion with a gynecologic oncologist is recommended.

Leiomyosarcoma in an HIV-infected adult with renal and central nervous system involvement.

We describe a case of leiomyosarcoma in an HIV-infected adult with renal and central nervous system involvement and possibly the lungs.

Heparin-induced thrombocytopenia: evaluation of IgG and IgGAM ELISA assays.

BACKGROUND: Heparin-induced thrombocytopenia (HIT) is a rare complication of heparin therapy resulting from antibody production to platelet factor 4 and heparin complexes (H-PF4). METHODS: We have evaluated four enzyme-linked immunosorbent assay (ELISA)-based screening tests to identify the best assay(s) with the highest specificity but without underdiagnosis of HIT. As functional assays are difficult to perform, ELISAs are useful to provide clinicians with a timely answer. Over a 10-month period, all samples (N=107) referred to our laboratory were tested for HIT antibodies using four commercially available ELISA kits, two detecting IgG/A/M anti-H-PF4 antibodies and the other two IgG specific. RESULTS: Twenty-eight samples were positive by at least one assay; IgGAM ELISAs were found to be more sensitive with 24 samples positive by Asserachrom IgGAM and 23 by Zymutest IgGAM. Only 18 samples were positive by GTI-PF4-IgG and Zymutest IgG. The gold standard serotonin release assay (SRA) was used as a confirmation assay, and 11/28 samples tested positive. All these SRA-positive samples were positive by all four assays. None of the IgGAM-only-positive samples was found to be positive by SRA suggesting a better specificity for the IgG-only assays. CONCLUSION: Our data strongly support the use of IgG-only assays for the detection of HIT antibodies.

Clinical utility of genotypic resistance tests for HIV-1-infected patients with low-level virological failure.

The usefulness of genotypic resistance tests (GRT) among HIV-1 patients with low-level virological failure (LLVF) was evaluated. Up to 78% of samples with <1,000 copies/ml were sequenced successfully. For samples with 50 to 200 copies/ml, the success rate was as high as 69%. LLVF should not deter clinicians from requesting GRT.

Cardiovascular risk evaluation and antiretroviral therapy effects in an HIV cohort: implications for clinical management: the CREATE 1 study.

AIMS: The aim of this study is to determine the cardiovascular disease (CVD) risk profile of a large UK HIV cohort and how highly active antiretroviral therapy (HAART) affects this. METHODS: It is a cross-sectional study within a large inner city hospital and neighbouring district hospital. A total of 1021 HIV positive outpatients representative of the complete cohort and 990 who had no previous CVD were included in CVD risk analysis. We recorded demographics, HAART history and CVD risk factors. CVD and coronary heart disease (CHD) risks were calculated using the Framingham (1991) algorithm adjusted for family history. RESULTS: The non-CVD cohort (n = 990) was 74% men, 51% Caucasian and 73.1% were on HAART. Mean age was 41 +/- 9 years, systolic blood pressure 120 +/- 14 mmHg, total cholesterol 4.70 +/- 1.05 mmol/l, high-density lipoprotein-C 1.32 +/- 0.48 mmol/l and 37% smoked. Median CVD risk was 4 (0-56) % in men and 1.4 (0-37) % in women; CHD risks were 3.5 (0-36) % and 0.6 (0-16) %. CVD risk was > 20% in 6% of men and 1% of women and > 10% in 12% of men and 4% of women. CVD risk was higher in Caucasians than other ethnicities; the risk factor contributing most was raised cholesterol. For patients on their first HAART, increased CHD risk (26.2% vs. 6.5%; odds ratio 4.03, p < 0.001) was strongly related to the duration of therapy. CONCLUSIONS: Modifiable risk factors, especially cholesterol, and also duration of HAART, were key determinants of CVD risk. DISCUSSION: Regular CHD and/or CVD risk assessment should be performed on patients with HIV, especially during HAART therapy. The effect of different HAART regimens on CHD risk should be considered when selecting therapy.

Morphometric and molecular differentiation of Phlebotomus (Phlebotomus) sandflies.

The closely related sandfly species of the subgenus Phlebotomus namely, Phlebotomus papatasi (Scopoli, 1786), Phlebotomus duboscqi Neveu-Lemair, 1906 and Phlebotomus bergeroti Parrot, 1934 (Diptera: Psychodidae), are major vectors of Leishmania major (Kinetoplastida: Trypanosomatidae), the causative agent of cutaneous leishmaniasis in the Old World. Although allopatric in most of their distribution, the three species exist sympatrically in many places in central and eastern Sudan. Males of the three species can be distinguished using morphological characters; however, females are much harder to identify, thus complicating epidemiological studies. We carried out a morphometric and a molecular study to determine reliable morphological features and develop a polymerase chain reaction (PCR) assay for distinguishing females of these species. Males and females from each species were collected from sites in Sudan, East Africa and from one site in Mali, West Africa. Males were analysed morphologically and 20 characters and 10 character ratios were used in a stepwise discriminant analysis. This led to the identification of four characters with high discriminant loading scores sufficient for accurate male species identification. Male DNA was then used for the development of a PCR-based species diagnostic based on the second internal transcribed spacer (ITS2) of the ribosomal DNA. A set of four primers was developed to generate fragment sizes that are specific to each species and can reliably identify females as well as hybrid DNA. Both the morphometric and the molecular findings of this study have important applications for studies of the epidemiology of cutaneous leishmaniasis.

Follow-up for women after treatment for cervical cancer.

QUESTION: What is the most appropriate follow-up strategy for patients with cervical cancer who are clinically disease-free after receiving primary treatment? PERSPECTIVES: For women with cervical cancer who have been treated with curative intent, follow-up includes identification of complications related to treatment and intervention in the event of recurrent disease. Most women who recur with cervical cancer are not curable; however, early identification of recurrence can alter disease management or treatment-planning options, and for those with a central pelvic recurrence and no evidence of distant disease, there is a potential for cure with additional therapy. Follow-up protocols in this population are variable, using a number of tests at a variety of intervals with questionable outcomes. OUTCOMES: Outcomes of interest included recurrence, survival, and quality of life. METHODOLOGY: The Gynecology Cancer Disease Site Group (DSG) conducted a systematic review of the literature and a narrative review of emerging clinical issues to inform the most appropriate follow-up strategy for patients with cervical cancer. The evidence was insufficient to specify a clinically useful recommended follow-up schedule, and therefore, the expert consensus opinion of the Gynecology Cancer DSG was used to develop recommendations on patient surveillance. The resulting recommendations were reviewed and approved by the Gynecology Cancer DSG and by the Program in Evidence-Based Care Report Approval Panel. An external review by Ontario practitioners completed the final phase of the review process. Feedback from all parties was incorporated to create the final practice guideline. RESULTS: The systematic review of the literature identified seventeen retrospective studies. The Gynecology Cancer DSG used a consensus process to develop recommendations based on the available evidence from the systematic review, the narrative review, and the collective clinical experience and judgment of the DSG members. PRACTICE GUIDELINE: The recommendations in this practice guideline are based on the expert consensus opinion of the Gynecology Cancer DSG, informed by evidence from retrospective studies. These are some general features of an appropriate follow-up strategy: 1. At a minimum, follow-up visits with a complete physical examination, including a pelvic-rectal exam and a patient history, should be conducted by a physician experienced in the surveillance of cancer patients. 2. There is little evidence to suggest that vaginal vault cytology adds significantly to the clinical exam in detecting early disease recurrence. 3. Routine use of various other radiologic or biologic follow-up investigations in asymptomatic patients is not advocated, because the role of those investigations has yet to be evaluated in a definitive manner. 4. A reasonable follow-up schedule involves follow-up visits every 3-4 months in the first 2 years and every 6-12 months in years 3-5. Patients should return to annual population-based general physical and pelvic examinations after 5 years of recurrence-free follow-up.

Use of a functional assay to diagnose protein S deficiency; inappropriate testing yields equivocal results.

Inherited deficiency of protein S (PS) is a rare but accepted risk factor for venous thromboembolism. There is accumulating evidence that inherited PS deficiency may be associated with a variety of adverse obstetric events. Acquired PS deficiency may be caused by a variety of clinical states including normal pregnancy. We conducted a retrospective audit of the results of screening for PS deficiency through our reference laboratory. The majority of patients in this audit with significantly reduced (<50%) free functional PS levels had a major confounding factor likely to cause acquired PS deficiency, most frequently pregnancy. Recommendations for PS testing for the diagnosis of hereditary PS deficiency include deferring testing until at least 40 days post-partum. It appears that these recommendations are not being adhered to leading to difficulty in the interpretation of results.

Insulin resistance and HIV infection: a review.

Highly active antiretroviral therapy (HAART) has markedly improved the prognosis of people with HIV infection. However, there are long-term side effects associated with HAART. Alterations in metabolic parameters are common and include hyperlipidaemia and insulin resistance (IR), either in isolation or as part of the lipodystrophy and metabolic syndromes. Insulin resistance is common in HIV-infected people, particularly among those being treated with protease inhibitor therapy. The prevalence of hyperglycaemia and diabetes mellitus is significantly higher in people with HIV infection being treated with antiretrovirals (ARVs), as compared with the general population. Hyperglycaemia is an important risk factor for the development of secondary pathology, including cardiovascular disease. It is therefore important to consider the effects of IR in HIV-infected individuals, and take measures to prevent or manage it appropriately. There is limited evidence for the benefit of pharmacological interventions for IR alone although the metabolic changes and body shape changes of lipodystrophy might benefit from the combined use of metformin with exercise. At present, therefore, it is best to concentrate on preventative measures, including lifestyle modification, the careful selection of ARV drugs, and changing drug combinations where appropriate.

Reduced fibrinolysis and increased fibrin generation can be detected in hypercoagulable patients using the overall hemostatic potential assay.

BACKGROUND: Routinely available coagulation assays are not capable of detecting clinically defined hypercoagulable states. A number of global coagulation assays have been developed with the potential to evaluate hypercoagulability, which predisposes to the common clinical events of arterial and venous thromboembolism (VTE). OBJECTIVES: We hypothesized that the overall hemostatic potential (OHP) assay would show abnormal fibrin generation and lysis in patients with clinically defined hypercoagulable states. METHODS: We used the OHP assay as described by Blombäck and colleagues [1,2] in 161 clinically hypercoagulable patients with arterial or VTE, pregnancy complications or autoimmune disease. Eighty patients had associated antiphospholipid antibodies (APLA). Ninety-eight normal plasma donors were tested for comparison. RESULTS: We derived three new assay parameters for correlation with hypercoagulable states: the maximum optical density, maximum slope, and delay in onset of fibrin generation. We found significantly different assay results for all patients' parameters examined when compared with controls, indicating both increased fibrin generation and reduced fibrinolysis in hypercoagulable patients. The findings were similar whether samples were collected in association with an acute thrombotic event or not. Estimated assay sensitivity for detection of a clinically defined hypercoagulable state was 96%. CONCLUSIONS: The OHP assay is a simple, inexpensive global test that is useful for assessing patients with hypercoagulable states including APLA. OHP results are significantly abnormal in hypercoagulable groups compared with controls, indicating that both increased fibrin generation and reduced fibrinolysis contribute to hypercoagulable states. The assay may ultimately assist in tailoring clinical management to patients' individual requirements.