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Reversal of Coagulopathy Using Prothrombin Complex Concentrates is Associated with Improved Outcome Compared to Fresh Frozen Plasma in Warfarin-Associated Intracranial Hemorrhage

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Abstract

Background

There are no studies demonstrating that prothrombin complex concentrates (PCC) improves outcome compared FFP in patients with warfarin-associated intracranial hemorrhage.

Methods

A prospective, observational study was conducted of patients who received PCC (Bebulin VH), FFP, or PCC + FFP. All groups received vitamin K 10 mg IV. INR reversal (<1.4), adverse events (venous thromboembolism, myocardial infraction, pulmonary edema), major hemorrhage (new or worsened intracranial hemorrhage, anemia requiring transfusion or GI bleed), and 3-month functional outcome were compared between the groups using Chi squared and logistic regression analysis.

Results

Of 64 patients, PCC alone was used in 16 (mean dose 48 IU/kg), FFP alone in 25 (mean dose 12.5 ml/kg), and PCC + FFP in 23 (median doses 47.4 IU/kg and 11.4 ml/kg, respectively). INR correction occurred in 88, 84, and 70 %, respectively. There were no differences in time to INR correction or adverse events between the groups, but FFP alone was associated with more major hemorrhage after administration (52 %, OR 5.0, 95 % CI 1.6–15.4, P = 0.006) and PCC with less (6 %, OR 0.1, 95 % CI 0.01–0.8, P = 0.033). After adjusting for age, admission GCS, initial INR, and bleed type, the use of PCC was associated with a lower risk of death or severe disability at 3-months (adjusted OR 0.02, 95 % CI 0.001–0.8, P = 0.039), while FFP alone was associated with a higher risk (adjusted OR 51.6, 95 % CI 1.2–2163.1, P = 0.039).

Conclusions

PCC adequately corrected INR without any increase in adverse events compared to FFP and was associated with less major hemorrhage and improved 3-month outcomes in patients with warfarin-associated intracranial hemorrhage.

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Authors and Affiliations

  1. Cerebrovascular Center of the Neurological Institute, Cleveland Clinic Foundation, 9500 Euclid Ave. S80, Cleveland, OH, 44195, USA

    Jennifer A. Frontera, Ken Uchino & Muhammad S. Hussain

  2. Neuroscience Intensive Care Unit, Departments of Neurosurgery and Neurology, Mount Sinai School of Medicine, New York, NY, USA

    Errol Gordon, Victor Zach & Maximo Jovine

  3. Hematology Division, Department of Medicine, Mount Sinai School of Medicine, New York, NY, USA

    Louis Aledort

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  1. Jennifer A. Frontera
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  2. Errol Gordon
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Correspondence to Jennifer A. Frontera.

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Frontera, J.A., Gordon, E., Zach, V. et al. Reversal of Coagulopathy Using Prothrombin Complex Concentrates is Associated with Improved Outcome Compared to Fresh Frozen Plasma in Warfarin-Associated Intracranial Hemorrhage. Neurocrit Care 21, 397–406 (2014). https://doi.org/10.1007/s12028-014-9972-0

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