ABSTRACT
BACKGROUND: Rapid and accurate determination of prothrombin time in trauma patients may help to faster control of bleeding induced coagulopathy. The goal of this prospective observational study was to investigate the accuracy of bedside measurements of prothrombin time by the mean of a point-of-care device (INRatio) in trauma patients. METHODS: Fifty blood samples were drawn at admission and during the acute care phase for standard coagulation assays (prothrombin time, International Normalized Ratio [INR], and fibrinogen) and INRatio testing (INR(A)) from 48 trauma patients. RESULTS: Standard coagulation assays were available after a mean of 66 minutes. Median Injury Severity Score was 18, and 16 patients (33%) had a coagulopathy. Significant correlation was found between INR and INR(A) (r: 0.93, 95% confidence interval: 0.87-0.96). The mean difference (bias) for INR was 0.00, and standard deviation (precision) of the difference was 0.78. However, in cases where there was decreased hemoglobin (<10 gr · L(-1)) and fibrinogen (<1.5 gr · L(-1)), bias and precision were increased. To predict the need for fresh frozen plasma transfusion (INR > 1.5), INR(A) cutoff value of 1.3 resulted in a sensitivity of 92% and a specificity of 79%. The area under the receiver operating characteristic curve was 0.946 (95% confidence interval: 0,845-0,982). CONCLUSION: INRatio may be a useful device in the management of trauma patients with ongoing or suspected coagulopathy that may help to save at least 60 minutes in the process of obtaining a prothrombin time result. It may allow earlier detection of coagulopathy and, together with vital sign and hemoglobin, may help to guide fresh frozen plasma transfusion.
Subject(s)
Blood Coagulation Disorders/diagnosis , Point-of-Care Systems/statistics & numerical data , Prothrombin Time/instrumentation , Wounds, Nonpenetrating/blood , Adult , Blood Coagulation Disorders/blood , Blood Coagulation Disorders/complications , Female , Follow-Up Studies , Humans , Injury Severity Score , Male , Middle Aged , Pilot Projects , Prospective Studies , Prothrombin Time/statistics & numerical data , ROC Curve , Reproducibility of Results , Wounds, Nonpenetrating/complications , Wounds, Nonpenetrating/diagnosisABSTRACT
We analysed changes in coagulation during normal pregnancy with a novel point-of-care device based on thrombelastometry (ROTEM). We compared the results obtained with those of standard coagulation tests in 104 patients: 20 non-pregnant women (controls) and 84 women in the first (T1, n = 17), second (T2, n = 9) and third (T3, n = 58) trimesters of pregnancy. We measured the clotting time (CT), the maximum clot firmness (MCF), the early clot amplitude at 5 and 15 minutes (CA(5), CA(15)) and the clot lysis index (CLI(30)) with four tests containing specific reagents. (a) The INTEM test involving ellagic acid activated the intrinsic pathway and (b) the EXTEM test using tissue factor triggered the extrinsic pathway; (c) The FIBTEM test based on a platelet inhibitor (cytochalasin D) evaluated the contribution of fibrinogen to clot formation and (d) the APTEM test was similar to the EXTEM but was based on inhibition in vitro of fibrinolysis by aprotinin. CT and CLI(30) were not significantly modified during pregnancy whereas MCF, CA(5) and CA(15) (INTEM, EXTEM, FIBTEM) increased significantly between the second and third trimesters (e.g. median [interquartile range]: MCF-FIBTEM, 13 [11-16] mm vs. 19 [17-23] mm, respectively, in controls and T3, p < 0.001). EXTEM values were not significantly different from those measured with APTEM. There were significant correlations between the results obtained with ROTEM and those from standard coagulation tests. ROTEM analysis showed a marked increase in coagulability during normal pregnancy. ROTEM values may serve as the basis for future studies in pregnant women.
