Open AccessPreclinical evaluation of point‐of‐care prothrombin time as a biomarker test to guide prothrombin replacement therapy in coagulopathic bleeding
Author(s) -
Balendran Clare A.,
Henderson Neil,
Olsson Marita,
Lövgren Ann,
Hansson Kenny M.
Publication year - 2017
Publication title -
research and practice in thrombosis and haemostasis
Language(s) - English
Resource type - Journals
ISSN - 2475-0379
DOI - 10.1002/rth2.12027
Subject(s) - prothrombin time , medicine , point of care , prothrombin complex concentrate , thromboplastin , gastroenterology , whole blood , coagulation , warfarin , pathology , atrial fibrillation
SummaryEssentials Prediction of bleeding risk in trauma patients is difficult. We evaluated a test which measures prothrombin time/ability of blood to clot. We showed the prothrombin time test reflected prothrombin concentration in blood. The test could be used in trauma patients to identify those in need of prothrombin replacement.Background Hemorrhage is still a common cause of death in trauma. Central lab measured prothrombin time (lab PT) is predictive of low prothrombin concentration and clinical outcome in trauma patients, however, treatment guidance is limited by slow turnaround times. Here, we have preclinically evaluated the potential of a point‐of‐care prothrombin time test (POC PT) as a faster alternative to identify patients with low prothrombin concentration. Methods Human whole blood was serially diluted and prothrombin time measured by POC PT (CoaguChek XS Pro, Roche) and lab PT. Recombinant human prothrombin (MEDI8111) was added to human whole blood with or without depletion of prothrombin by pretreatment with prothrombin neutralizing antibodies. Results There was no observable difference in the sensitivity of either test to dilution at blood volumes of 60‐100%. At blood volumes of ≤55% (equivalent to 47 mg/L prothrombin), PT sharply increased, with greater dilutional sensitivity observed in the POC test. Both tests were insensitive to prothrombin up to 194 mg/L added MEDI8111 (equivalent to 328 mg/L prothrombin versus endogenous concentration of 129 mg/L). Depletion of endogenous prothrombin inversely correlated with an increase in PT which returned to baseline following addition of 97 mg/L MEDI8111 or above. Both assays correlated well above 48.5 mg/L added MEDI8111 (65.9 mg/L prothrombin). Conclusions Our data supports that POC PT tests, such as the CoaguChek XS Pro, are fit for purpose to confirm a coagulopathic threshold for prothrombin and provide a fast, simple, and mobile method to guide MEDI8111 therapy in bleeding trauma patients.