Use of Prothrombin Complex Concentrate as an Adjunct to Fresh Frozen Plasma Shortens Time to Craniotomy in Traumatic Brain Injury Patients (original) (raw)

Reversal of warfarin associated coagulopathy with 4-factor prothrombin complex concentrate in traumatic brain injury and intracranial hemorrhage

Journal of Clinical Neuroscience, 2014

Warfarin-associated intracranial hemorrhage is associated with a high mortality rate. Ongoing coagulopathy increases the likelihood of hematoma expansion and can result in catastrophic hemorrhage if surgery is performed without reversal. The current standard of care for emergency reversal of warfarin is with fresh frozen plasma (FFP). In April 2013, the USA Food and Drug Administration approved a new reversal agent, 4-factor prothrombin complex concentrate (PCC), which has the potential to more rapidly correct coagulopathy. We sought to to determine the feasibility and outcomes of using PCC for neurosurgical patients. A prospective, observational study of all patients undergoing coagulopathy reversal for intracranial hemorrhage from April 2013 to December 2013 at a single, tertiary care center was undertaken. Thirty three patients underwent emergent reversal of coagulopathy using either FFP or PCC at the discretion of the treating physicians. Intracranial hemorrhage included subdural hematoma, intraparenchymal hematoma, and subarachnoid hemorrhage. FFP was used in 28 patients and PCC was used in five patients. International normalized ratio at presentation was similar between groups (FFP 2.9, PCC 3.1, p = 0.89). The time to reversal was significantly shorter in the PCC group (FFP 256 minutes, PCC 65 minutes, p < 0.05). When operations were performed, the time delay to perform operations was also significantly shorter in the PCC group (FFP 307 minutes, PCC 159 minutes, p < 0.05). In this preliminary experience, PCC appears to provide a rapid reversal of coagulopathy. Normalization of coagulation parameters may prevent further intracranial hematoma expansion and facilitate rapid surgical evacuation, thereby improving neurological outcomes.

The incidence and effect of coagulopathy on short-term outcomes in patients undergoing craniotomy following traumatic brain injury

Journal of Neuroanaesthesiology and Critical Care

Background: Coagulopathy in isolated traumatic brain injury (TBI) is well-known, and studies have found an association between coagulopathy and unfavourable outcomes. This study was conducted to determine the incidence and causes of coagulopathy in patients with TBI undergoing craniotomy and its effect on post-operative outcome. Materials and Methods: The data collected was demographics, computed tomography diagnosis, post-resuscitation Glasgow Coma Scale (GCS) score, pre- and post-operative platelet count, liver function tests, intraoperative blood loss and transfusion, fluids infused and incidence of redo surgery. Point of care (Coaguchek XS) monitor was used to obtain prothrombin time and international normalised ratio (INR) at 24 h and 72 h of injury. Coagulopathy was defined as INR ≥1.3 and thrombocytopenia as platelet count ≤100,000/mcL. Outcome measures assessed were the length of hospital stay, GCS at discharge and in-hospital mortality. Results: In 166 patients, the average...

Prothrombin complex concentrate: an effective therapy in reversing the coagulopathy of traumatic brain injury

The journal of trauma and acute care surgery, 2013

Coagulopathy in patients with traumatic brain injury (TBI) is a well-studied concept. Prothrombin complex concentrate (PCC) has been shown to be an effective treatment modality for correction of TBI coagulopathy. However, its use and effectiveness compared with recombinant factor VII (rFVIIa) in TBI has not been established. The purpose of this study was to compare PCC and rFVIIa for the correction of TBI coagulopathy. All patients with a TBI and an induced or acquired coagulopathy whom received rFVIIa or PCC at our Level I trauma center during a 4-year period were reviewed. Data collected included demographics, changes in international normalized ratio and blood products transfusion, craniotomy rates, and time to neurosurgical intervention, thromboembolic complications, and mortality differences. The study was composed of 85 TBI patients, of whom 64 patients received PCC while 21 patients received rFVIIa. PCC group were more likely to be on coumadin (44% vs. 14%, p = 0.01). There w...

A Protocol for the Rapid Normalization of INR in Trauma Patients with Intracranial Hemorrhage on Prescribed Warfarin Therapy

The American Surgeon, 2008

Trauma patients on prescribed warfarin therapy sustaining intracranial hemorrhage can be difficult to manage. Rapid normalization of coagulopathy is imperative to operative intervention and may affect outcomes. To identify and expedite warfarin reversal, we designed a protocol to administer a prothrombin complex concentrate. A Proplex T protocol was instituted in May 2004. It dictated that trauma patients with an International Normalized Ratio (INR) greater than 1.5, history of prescribed warfarin therapy, and intracranial hemorrhage on CT scan receive a prothrombin complex concentrate for reversal of their coagulopathy. Neither the protocol nor the factor concentrate was validated for use in this subset of trauma patients; therefore, adherence to the protocol and use of the factor concentrate was not mandatory. Patients not administered the prothrombin complex concentrate received vitamin K and fresh-frozen plasma. The protocol resulted in an increased number of patients receiving ...

Implementation of Thromboelastometry for Coagulation Management in Isolated Traumatic Brain Injury Patients Undergoing Craniotomy

Medical Science Monitor, 2020

Departmental sources Background: Coagulopathy (CP) is a modifiable factor linked with secondary brain damage and poor outcome of traumatic brain injury (TBI). A shift towards goal-directed coagulation management has been observed recently. We investigated whether rotational thromboelastometry (ROTEM) based management could be successfully implemented in TBI patients and improve outcomes. Material/Methods: A prospective, case-control study was performed. Adult patients with isolated TBI requiring craniotomy were included in this study. All patients underwent standard coagulation tests (SCT). Patients were identified as either in control group or in case group. Patients in the case group were additionally tested with ROTEM to specify their coagulation status. Management of the patients in the control group was based on SCT, whereas management of patients in the case group was guided by ROTEM. Outcome measures were as follows: CP rate, protocol adhesion, blood loss, transfusions, progressive hemorrhagic injury (PHI), re-intervention, Glasgow coma score (GCS) and Glasgow outcome score (GOS) at discharge, and in-hospital mortality. Results: There were 134 patients enrolled (65 patients in the control group and 69 patients in the case group). Twentysix patients in the control group (40%) were found to be coagulopathic (control-CP subgroup) and 34 patients in the case group (49.3%) were found to be coagulopathic (case-CP subgroup). Twenty-five case-CP patients had ROTEM abnormalities triggering protocolized intervention, and 24 of them were treated. Overall ROTEMbased protocol adhesion rate was 85.3%. Postoperative ROTEM parameters of case-CP patients significantly improved, and the number of coagulopathic patients decreased. The incidence of PHI (control versus case group) and neurosurgical re-intervention (control-CP versus case-CP subgroup) was in favor of ROTEM guidance (P<0.05). Mortality and GCS and GOS at discharge did not differ significantly between groups. Conclusions: ROTEM led to consistent coagulation management, improved clot quality, and decreased incidence of PHI and neurosurgical re-intervention. Further studies are needed to confirm benefits of ROTEM in cases of TBI.

The role of coagulopathy on clinical outcome following traumatic brain injury in children: analysis of 66 consecutive cases in a single center institution

Child's Nervous System, 2018

Introduction Head injury is a significant economic, social, and medical problem in developing countries and remains one of the leading causes of pediatric morbidity and mortality. The association of traumatic brain injury and coagulopathy in children is linked with an increase in mortality and poor functional outcomes. However, its impact on long-term outcome has not been discussed in the literature so far. Objectives The aim of this paper was to investigate the effect of coagulopathy diagnosed by routine laboratory tests on neurological outcome following traumatic brain injury in children. Methods A retrospective review was carried out using medical records of children with a traumatic brain injury admitted at a level I trauma center, between January 2013 and December 2016, submitted to any neurosurgical procedures. Statistical analysis was performed accordingly to identify factors predicting unfavorable or favorable outcomes at 1-and 6-month follow-ups. Data regarding age, gender, trauma mechanism, Glasgow Coma Scale at admission and at discharge, highest and lowest stable intracranial pressure, serum glucose and coagulation assessment, radiological findings, and length of stay were analyzed. Results We identified 66 children with surgical head trauma. Mean age was 10.9 years (ranges from 3 months to 17 years), with male predominance (77.3%). Common mechanisms were road traffic accidents (66.7%), falls (19.7%), and blunt trauma (10.6%). Brain edema was detected in 68.2% of the patients, surgical fractures or intracranial bleeding in 75.8%. ICP monitoring was performed in 24.2% of the patients, and of these, 18.7% underwent consecutive decompressive craniectomy. Mean length of in-patient treatment was 16.3 ± 28.2 days. At 1-and 6-month follow-ups, favorable outcome was detected in 71.2 and 78.7% of the patients, respectively. The mortality rate was 12.1%. Routine coagulation assessments such as prothrombin time, fibrinogen levels, and thrombocyte count upon admission were potential prognostic variables identified. Conclusions The present study concluded that a trauma-related coagulopathy is an important predictor of unfavorable neurological outcome following TBI in pediatric patients. Initial GCS score, age, and neuroradiological findings, such as severe brain edema and different types of intracranial bleeding, correlated with GOS in the first 6 months following TBI. Sustained intracranial hypertension also predicted unfavorable outcome and death in this series.

Prothrombin Complex Concentrate Versus Fresh-Frozen Plasma for Reversal of Coagulopathy of Trauma: Is There a Difference?

World Journal of Surgery, 2014

Introduction The development of coagulopathy of trauma is multifactorial associated with hypoperfusion and consumption of coagulation factors. Previous studies have compared the role of factor replacement versus FPP for reversal of trauma coagulopathy. The purpose of our study was to determine the time to correction of coagulopathy and blood product requirement in patients who received PCC?FFP compared with patients who received FFP alone. Methods We performed a retrospective analysis of a prospectively maintained database of all coagulopathic (INR C 1.5) trauma patients presenting to our level I trauma center during a 2-years period (2011)(2012). Patients were stratified into two groups: patients who received PCC?FFP and patients who received FFP alone. Patients in the two groups were matched in a 1:3 (PCC?FFP:FFP) ratio using propensity score matching for demographics, injury severity, vital parameters, and initial INR. The two groups were then compared for: correction of INR, time to correction of INR, thromboembolic complications, mortality, and cost of therapy.

Correlation between coagulopathy and outcome in severe head trauma in neurointensive care and trauma units

Journal of Critical Care, 2011

Background: Abnormal blood coagulation after traumatic brain injury is a common finding. Some studies have proposed these changes as useful predictors of outcome in patients with head trauma. This study aimed at evaluating the association of the routine tests of blood coagulation within the first hours after severe head trauma with prognosis of patients with severe head trauma. Materials and Methods: A total of 52 patients with severe head trauma (Glasgow Coma Scale [GCS], ≤8) were admitted at Tabriz University Hospital for 1 year. Patients with major accompanying trauma were excluded. On admission, serum levels of hemoglobin and hematocrit as well as the platelet count, prothrombin time (PT), partial thromboplastin time (PTT), and international normalized ratio (INR) were documented. The relation between these parameters with final outcome and also with GCS at admission, 24 hours, 48 hours, and 1 week after admission and discharge time and Glasgow Outcome Scale (GOS) were studied. Results: Thirty three patients were discharged, and 19 died. There were significant negative correlations between PT, PTT, and INR with all GCS and GOS scores. These correlations were significant and positive between the platelet count and all GCS and GOS scores. Median PT, PTT, and INR were significantly higher in nonsurvivors. Median serum platelets count was significantly lower in nonsurvivors. Conclusion: On-admission PT, PTT, INR and platelet count may be used as predictors of outcome and prognosis of patients with severe head trauma. Published by Elsevier Inc. ☆ Authors do not have any financial and personal relationships with other people or organizations that could inappropriately influence (bias) their work. Examples of potential conflicts of interest include employment, consultancies, stock ownership, honoraria, paid expert testimony, patent applications/registrations, and grants or other funding.