Evaluation of a fixed, weight-based dose of 3-factor prothrombin complex concentrate without adjunctive plasma following warfarin-associated intracranial hemorrhage.
BACKGROUND
Data regarding use of prothrombin complex concentrate (PCC) for international normalization ratio (INR) reversal in warfarin-associated intracranial hemorrhage (wICH) is variable with regards to dosages, adjunctive agents, and product choice. In 2012, we implemented a fixed, weight-based [30 IU/kg] dosing protocol of 3-factor PCC (3PCC) utilizing a rapid infusion rate and no requirement for fresh frozen plasma (FFP) following factor product administration. We aimed to evaluate the impact of this protocol on immediate and delayed INR reversal in patients admitted with wICH in the absence of FFP co-administration.


METHODS
We conducted a retrospective review of patients receiving 3PCC following wICH between January 1, 2012 and December 10, 2013. The primary objective was to determine the percentage of patients achieving goal INR (≤1.4) following 3PCC administration. Patients were excluded if their bleed was not intracranial in origin, received a dose outside of the specified protocol, or were given FFP as an adjunctive agent.


RESULTS
We included 35 patients with a mean presenting INR of 3.2 ± 1.3. Thirty patients (85.7%) achieved goal INR (≤1.4) following one dose of 3PCC. The mean INR after infusion of 3PCC was 1.3 ± 0.2. The median duration between 3PCC infusion and subsequent INR was 48.0 min (30-70.1 min). Vitamin K was utilized in 33 (94.3%) patients. No patient experienced a thromboembolic event within 7 days of 3PCC administration.


CONCLUSIONS
Fixed, weight-based dosing of 3PCC without adjunctive FFP resulted in high rates of complete INR reversal without significant adverse events.
Department of Pharmacy, Temple University Hospital, 3401 N Broad St, Philadelphia, PA, 19140, USA, kmohrien@gmail.com.
Kerry M
KM
Mohrien
G
G
Morgan Jones
Andrew B
AB
Boucher
Lucas
L
Elijovich
D000368:Aged; D001779:Blood Coagulation Factors / Q000008:administration & dosage* / Q000494:pharmacology*; D002985:Clinical Protocols / Q000592:standards; D054796:Drug Dosage Calculations; D005260:Female; D006801:Humans; D019934:International Normalized Ratio; D020300:Intracranial Hemorrhages / Q000188:drug therapy* / Q000209:etiology; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D014859:Warfarin / Q000009:adverse effects*
D001779:Blood Coagulation Factors; C025667:prothrombin complex concentrates; D014859:Warfarin