Clinical experience with three-factor prothrombin complex concentrate to reverse warfarin anticoagulation in intracranial hemorrhage.
OBJECTIVE
The effectiveness of prothrombin complex concentrate (PCC) products available in the United States that contain low levels of factor VII (3-factor PCC) has not been tested. The purpose of this study was to review our experience with 3-factor PCC (Profilnine) in the setting of warfarin-associated intracranial hemorrhage (wICH).


METHODS
In November 2007, we implemented a protocol for reversal of anticoagulation in wICH using Profilnine. Additional treatment with fresh-frozen plasma was at the discretion of the treating physician. Medical records of all patients receiving PCC for wICH between November 1, 2007, and December 7, 2011 were reviewed. Correction of the international normalized rate (INR) was defined as an INR <1.4.


RESULTS
Seventy wICH patients were treated with Profilnine, including 46 (66%) with intraparenchymal hemorrhage, 22 (31%) with subdural hemorrhage, and 2 (3%) with subarachnoid hemorrhage. Mean INR was reduced from 3.36 to 1.96, and in 44 (62.9%) patients the INR corrected to <1.4. Baseline INR ≥3.0 decreased the likelihood of INR correction. Concomitant administration of fresh-frozen plasma (mean, 2.6 U) did not increase the likelihood of INR correction. Seven (10%) patients had serious adverse events during their hospital course, including 2 sudden deaths from suspected pulmonary embolism.


CONCLUSIONS
Reversal of coagulopathy in wICH with Profilnine was incomplete and associated with serious adverse events. In the absence of available 4-factor PCC, options for urgent reversal of anticoagulation in wICH remain limited.
Department of Neurology, Georgia Health Sciences University, 1122 15th Street, Augusta, GA 30912, USA. jswitzer@georgiahealth.edu
Jeffrey A
JA
Switzer
Jody
J
Rocker
Phillip
P
Mohorn
Jennifer L
JL
Waller
Douglas
D
Hughes
Askiel
A
Bruno
Fenwick T
FT
Nichols
David C
DC
Hess
Kavita
K
Natarajan
Susan C
SC
Fagan
D000925:Anticoagulants / Q000009:adverse effects / Q000037:antagonists & inhibitors*; D001779:Blood Coagulation Factors / Q000627:therapeutic use*; D002543:Cerebral Hemorrhage / Q000139:chemically induced* / Q000188:drug therapy*; D006801:Humans; D019934:International Normalized Ratio; D053208:Kaplan-Meier Estimate; D016019:Survival Analysis; D014057:Tomography, X-Ray Computed; D014859:Warfarin / Q000009:adverse effects / Q000037:antagonists & inhibitors*
D000925:Anticoagulants; D001779:Blood Coagulation Factors; C025667:prothrombin complex concentrates; D014859:Warfarin