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Performance of point-of-care international normalized ratio measurement to diagnose trauma-induced coagulopathy.

ABSTRACT: Trauma-induced coagulopathy (TIC) is a common feature after severe trauma. Detection of TIC is based upon classic coagulation tests including international normalized ratio (INR) value. Point-of-care (POC) devices have been developed to rapidly measure INR at the bedside on whole blood. The aim of the study was to test the precision of the Coagucheck® XS Pro device for INR measurement at hospital admission after severe trauma.We conducted a prospective observational study in a French level I trauma center. From January 2015 to May 2016, 98 patients with a suspicion of a post-traumatic acute hemorrhage had POC-INR measurement on whole blood concomitantly to classic laboratory INR determination (lab-INR) on plasma at hospital admission. The agreement between the two methods in sorting three predefined categories of INR (normal coagulation, moderate TIC and severe TIC) was evaluated using the Cohen's kappa test with a quadratic weighting. The correlation between POC-INR and lab-INR was measured using the Pearson's coefficient. We also performed a Bland and Altman analysis.The agreement between the lab-INR and the POC-INR was moderate (Kappa?=?0.45 [95% CI 0.36-0.50]) and the correlation between the two measurements was also weak (Pearson's coefficient?=?0.44 [95% CI 0.27-0.59]). Using a Bland and Altman analysis, the mean difference (bias) for INR was 0.22 [95% CI 0.02-0.42], and the standard deviation (precision) of the difference was 1.01.POC Coagucheck® XS Pro device is not reliable to measure bedside INR. Its moderate agreement with lab-INR weakens the usefulness of such device after severe trauma.NCT02869737 . Registered 9 August 2016.

SUBMITTER: Mistral T

PROVIDER: S-EPMC5480161 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature

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Performance of point-of-care international normalized ratio measurement to diagnose trauma-induced coagulopathy.

Mistral Thomas T Boué Yvonnick Y Bosson Jean-Luc JL Manhes Pauline P Greze Jules J Brun Julien J Albaladejo Pierre P Payen Jean-François JF Bouzat Pierre P

Scandinavian journal of trauma, resuscitation and emergency medicine 20170621 1

<h4>Background</h4>Trauma-induced coagulopathy (TIC) is a common feature after severe trauma. Detection of TIC is based upon classic coagulation tests including international normalized ratio (INR) value. Point-of-care (POC) devices have been developed to rapidly measure INR at the bedside on whole blood. The aim of the study was to test the precision of the Coagucheck® XS Pro device for INR measurement at hospital admission after severe trauma.<h4>Methods</h4>We conducted a prospective observat ...[more]

PMID: 28637514

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Project description:Acute traumatic coagulopathy is associated with adverse outcomes including death. Previous studies examining acute traumatic coagulopathy's relation with mortality are limited by inconsistent criteria for syndrome diagnosis, inadequate control of confounding, and single-center designs. In this study, we validated the admission international normalized ratio as an independent risk factor for death and other adverse outcomes after trauma and compared two common international normalized ratio-based definitions for acute traumatic coagulopathy.Multicenter prospective observational study.Nine level I trauma centers in the United States.A total of 1,031 blunt trauma patients with hemorrhagic shock.None.International normalized ratio exhibited a positive adjusted association with all-cause in-hospital mortality, hemorrhagic shock-associated in-hospital mortality, venous thromboembolism, and multiple organ failure. Acute traumatic coagulopathy affected 50% of subjects if defined as an international normalized ratio greater than 1.2 and 21% of subjects if defined by international normalized ratio greater than 1.5. After adjustment for potential confounders, acute traumatic coagulopathy defined as an international normalized ratio greater than 1.5 was significantly associated with all-cause death (odds ratio [OR], 1.88; p < 0.001), hemorrhagic shock-associated death (OR, 2.44; p = 0.001), venous thromboembolism (OR, 1.73; p < 0.001), and multiple organ failure (OR, 1.38; p = 0.02). Acute traumatic coagulopathy defined as an international normalized ratio greater than 1.2 was not associated with an increased risk for the studied outcomes.Elevated international normalized ratio on hospital admission is a risk factor for mortality and morbidity after severe trauma. Our results confirm this association in a prospectively assembled multicenter cohort of severely injured patients. Defining acute traumatic coagulopathy by using an international normalized ratio greater than 1.5 but not an international normalized ratio greater than 1.2 identified a clinically meaningful subset of trauma patients who, adjusting for confounding factors, experienced more adverse outcomes. Targeting future therapies for acute traumatic coagulopathy to patients with an international normalized ratio greater than 1.5 may yield greater returns than using a lower international normalized ratio threshold.

Project description:BackgroundLife-long vitamin K antagonist (VKA) therapy is recommended as a standard of care in antiphospholipid syndrome (APS) patients with thrombosis. Concerns have been raised about the validity of international normalized ratio (INR) measurements in lupus anticoagulant (LA)-positive APS patients because LA may interfere with phospholipid-dependent coagulation tests and could elevate INR measurements.ObjectivesHere, we aimed to determine the interference of antigen-specific monoclonal and isolated patient antibodies with LA activity on INR measurements.MethodsPooled normal plasma and control plasma from patients on VKA (without LA) were incubated with monoclonal and isolated patient immunoglobulin G antiprothrombin and anti-beta-2-glycoprotein I antibodies that express LA activity. INR was determined before and after addition using 3 laboratory assays (Owren STA-Hepato Prest, Quick STA-NeoPTimal, and Quick STA-Neoplastine R) and 1 point-of-care test device (CoaguChek Pro II).ResultsAntiprothrombin and anti-beta-2-glycoprotein I antibodies with LA activity interfered with recombinant human thromboplastin reagents (Quick STA-Neoplastine R and CoaguChek Pro II), particularly when added to plasma of VKA-treated controls. This effect was most evident on point-of-care test INR measurements, while the recombinant Quick reagent exhibited a lesser degree of interference. In contrast, tissue-derived thromboplastin reagents (Owren STA-Hepato Prest and Quick STA-NeoPTimal) remained largely unaffected by these antibodies, both in pooled normal plasma and VKA anticoagulated control plasma. Among these reagents, the Owren INR reagent exhibited the lowest sensitivity to the influence of LA antibodies. This observed difference in sensitivity is independent of the plasma dilution factor or the presence of factor V or fibrinogen in Owren reagent.ConclusionINR reagents that utilize recombinant human thromboplastin are more sensitive to the presence of monoclonal and patient-derived antibodies with LA activity. Consequently, APS patients positive for LA should be monitored using tissue-derived thromboplastin reagents, given its reduced susceptibility to interference by LA-causing antibodies.

Project description:BackgroundCurrently, there is a lack of sepsis screening tools that can be widely used worldwide. Pulmonary sepsis can be of sufficient concern to physicians due to their noticeable symptoms, which usually rely less on screening tools.AimTo investigate the efficiency of the international normalized ratio (INR) for the early rapid recognition of adult nonpulmonary infectious sepsis.MethodsThis is a prospective observational study. A total of 108 sepsis patients and 106 nonsepsis patients were enrolled according to relevant inclusion and exclusion criteria. Commonly used clinical indicators, such as white blood cell, neutrophil count, lymphocyte count, neutrophil-lymphocyte count ratio (NLCR), platelets (PLT), prothrombin time, INR, activated partial thromboplastin time, and quick Sequential "Sepsis-related" Organ Failure Assessment (qSOFA) scores were recorded within 24 h after admission. The diagnostic performances of these clinical indicators were analyzed and compared through multivariate logistic regression analysis, Spearman correlation, and receiver operating characteristic curve analysis.ResultsThe INR value of the sepsis group was significantly higher than that of the nonsepsis group. INR has superior diagnostic efficacy for sepsis, with an area under the curve value of 0.918, when those preexisting diseases which significantly affect coagulation function were excluded. The diagnostic efficacy of the INR was more significant than that of NLCR, PLT, and qSOFA (P < 0.05). Moreover, INR levels of 1.17, 1.20, and 1.22 could be used to categorize the relative risk of nonpulmonary infections sepsis into three categories: low, medium and high risk, respectively.ConclusionThe INR is a promising and easily available biomarker for diagnosis, and it can be used as one of the indicators for early screening of adult nonpulmonary infectious sepsis. When its value is higher than the optimal cutoff value (1.22), high vigilance is required for adult nonpulmonary infectious sepsis.

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Performance of point-of-care international normalized ratio measurement to diagnose trauma-induced coagulopathy.

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Performance of point-of-care international normalized ratio measurement to diagnose trauma-induced coagulopathy.

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