Prediction score for effective bleeding control using recombinant activated factor VII in perioperative nonhemophilic patients

Rujirojindakul, Panthila; Rujirojindakul, Pairaya; McNeil, Edward; Geater, Alan; Chanchayanon, Thavat; Sangthong, Burapat; Chittithavorn, Voravit

doi:10.1016/j.amjsurg.2012.11.016

Cited by 4 publications

(3 citation statements)

References 17 publications

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“…Furthermore, PT is predictive of prothrombin concentration of less than 60 IU/dL (60% of normal) and of transfusion demand and clinical outcome . The correlation between prolonged PT and increased patient mortality has also been shown by others supporting its utility as a predictive biomarker of outcome.…”

Section: Introductionsupporting

confidence: 75%

Preclinical evaluation of point‐of‐care prothrombin time as a biomarker test to guide prothrombin replacement therapy in coagulopathic bleeding

Balendran

Henderson

Olsson

et al. 2017

Research and Practice in Thrombosis and Haemostasis

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Summary Essentials 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. BackgroundHemorrhage 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.MethodsHuman 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.ResultsThere 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).ConclusionsOur 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.

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Section: Introductionsupporting

confidence: 75%

Preclinical evaluation of point‐of‐care prothrombin time as a biomarker test to guide prothrombin replacement therapy in coagulopathic bleeding

Balendran

Henderson

Olsson

et al. 2017

Research and Practice in Thrombosis and Haemostasis

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“…The timing of rFVIIa administration is related to its efficacy. “Last-ditch” use of rFVIIa in severe bleeding is believed to be ineffective [ 28 ]. As rFVIIa acts locally at vascular injury sites [ 25 ], it may have an earlier role in haemostatic stability in the acute bleeding patients.…”

Section: Discussionmentioning

confidence: 99%

Recombinant activated factor VII (rFVIIa) in refractory haemorrhage for non-haemophiliacs: an eleven-year single-centre experience

et al. 2018

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BackgroundMassive bleeding is one of the commonest salvageable causes of death. The search for an ideal haemostatic agent during massive bleeding is still ongoing. One of the novel haemostatic medications is recombinant activated factor VII (rFVIIa). To date, the usage of rFVIIa during massive haemorrhage among non-haemophiliac patients remains off-label. The aim of this study is to report our experience in using rFVIIa to treat refractory bleeding.MethodsMedical records of all patients treated with rFVIIa for massive bleeding over an eleven-year period in a single institution were recorded. Treatment indications, 24-h and 30-day mortality, changes in transfusion needs and coagulation profiles after rFVIIa administration were analysed.ResultsrFVIIa were administered in 76 patients. Of these, 41 (53.9%) were non-surgical bleeding, followed by 22 patients (28.9%) with trauma, other surgery bleedings in 9 patients (11.8%) and 4 patients (5.4%) with peripartum haemorrhage. Total survival rate was 78.9% within 24 h and 44.7% over 30 days. Among all these patients who had received rFVIIa due to life-threatening haemorrhage, blood and blood product requirements were significantly reduced (P < 0.001), and the coagulation profiles improved significantly (P < 0.05). Two patients with preexisting thromboembolism were given rFVIIa due to intractable bleeding, both survived. No thromboembolic events were reported after the administration of rFVIIa.ConclusionsrFVIIa significantly improved coagulation parameters and reduced blood product requirements during refractory haemorrhage. Additionally, usage of rFVIIa in trauma and peripartum haemorrhage patients yield better outcomes than other groups of patients. However, the overall mortality rate remained high.

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“…ROTEM and TEG, where available, are used for this purpose and for guiding therapy [7–9, 20]. In hemorrhagic patients the PT assay has as far as we are aware been used to analyse retrospective data, although it is sometimes used as a tool to confirm the effectiveness of hemostatic therapy [21]. …”

Section: Discussionmentioning

confidence: 99%

Prothrombin time is predictive of low plasma prothrombin concentration and clinical outcome in patients with trauma hemorrhage: analyses of prospective observational cohort studies

Balendran

Lövgren

Hansson

et al. 2017

Scand J Trauma Resusc Emerg Med

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BackgroundFibrinogen and prothrombin have been suggested to become rate limiting in trauma associated coagulopathy. Administration of fibrinogen is now recommended, however, the importance of prothrombin to patient outcome is unknown.MethodsWe have utilized two trauma patient databases (database 1 n = 358 and database 2 n = 331) to investigate the relationship of plasma prothrombin concentration on clinical outcome and coagulation status. Database 1 has been used to assess the relationship of plasma prothrombin to administered packed red blood cells (PRBC), clinical outcome and coagulation biomarkers (Prothrombin Time (PT), ROTEM EXTEM Coagulation Time (CT) and Maximum Clot Firmness (MCF)). ROC analyses have been performed to investigate the ability of admission coagulation biomarkers to predict low prothrombin concentration (database 1), massive transfusion and 24 h mortality (database 1 and 2). The importance of prothrombin was further investigated in vitro by PT and ROTEM assays in the presence of a prothrombin neutralizing monoclonal antibody and following step-wise dilution.ResultsPatients who survived the first 24 h had higher admission prothrombin levels compared to those who died (94 vs.67 IU/dL). Patients with lower transfusion requirements within the first 24 h (≤10 units of PRBCs) also had higher admission prothrombin levels compared to patients with massive transfusion demands (>10 units of PRBCs) (95 vs.62 IU/dL). Admission PT, in comparison to admission ROTEM EXTEM CT and MCF, was found to be a better predictor of prothrombin concentration <60 IU/dL (AUC 0.94 in database 1), of massive transfusion (AUC 0.92 and 0.81 in database 1 and 2 respectively) and 24 h mortality (AUC 0.90 and 0.78 in database 1 and 2, respectively). In vitro experiments supported a critical role for prothrombin in coagulation and demonstrated that PT and ROTEM EXTEM CT are sensitive methods to measure low prothrombin concentration.DiscussionOur analyses suggest that prothrombin concentration at admission is predictive of mortality and transfusion and indicates that prothrombin and fibrinogen are rate limiting in coagulopathy.ConclusionsAdmission PT is predictive of low prothrombin concentration and clinical outcome. PT could therefore be used as a surrogate for prothrombin concentration and further evaluation of point-of-care devices for faster PT analysis is warranted.

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Prediction score for effective bleeding control using recombinant activated factor VII in perioperative nonhemophilic patients

Cited by 4 publications

References 17 publications

Preclinical evaluation of point‐of‐care prothrombin time as a biomarker test to guide prothrombin replacement therapy in coagulopathic bleeding

Preclinical evaluation of point‐of‐care prothrombin time as a biomarker test to guide prothrombin replacement therapy in coagulopathic bleeding

Recombinant activated factor VII (rFVIIa) in refractory haemorrhage for non-haemophiliacs: an eleven-year single-centre experience

Prothrombin time is predictive of low plasma prothrombin concentration and clinical outcome in patients with trauma hemorrhage: analyses of prospective observational cohort studies

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