A new kid on the block: Outcomes with Kcentra 1 year after approval.
BACKGROUND
As the population ages, more trauma patients are admitted with coagulopathy. Fresh frozen plasma is effective in reversing coagulopathy caused by warfarin; however, it is not appropriate for all patients. Prothrombin complex concentrates (PCCs) are an alternative for patients who require emergent reversal, minimal-volume administration and who have a supratherapeutic international normalized ratio (INR). A four-factor PCC initially approved in Europe is now available in the United States. We sought to review our experience with Kcentra (4F-PCC) in the first year following Food and Drug Administration approval.


METHODS
All trauma patients admitted to an academic Level 1 trauma center between July 15, 2013, and July 15, 2014, who received 4F-PCC for reversal of warfarin-induced coagulopathy were reviewed. 4F-PCC was given as per protocol. Univariate analysis was performed to examine patient demographics, injury characteristics, coagulation studies, 4F-PCC dose, vitamin K use, transfusions, response to reversal, duration of reversal, complications, and mortality.


RESULTS
Twenty-six patients met study criteria. Of these patients, 34.6% were reversed because of intracranial hemorrhage. The mean INR decreased from 5.7 ± 6.1 (range, 1.6-30) to 1.5 ± 0.4 (range, 1.2-2.6) after 4F-PCC administration. One patient (3.8%) received concurrent fresh frozen plasma. For patients with an initial INR greater than 5.0, the mean INR decreased from 12.0 ± 8.2 to 1.6 ± 0.5. Forty-eight hours following 4F-PCC administration, mean INR for all patients remained 1.4 ± 0.4 (range, 1.0-2.6). Of the patients, 80.8% received vitamin K over this period. Fourteen patients had a pre-4F-PCC thromboelastogram; four were hypocoagulable. Two patients had repeat thromboelastograms after 4F-PCC was given, which demonstrated normal coagulation. Of the patients with intracranial hemorrhage, 66.7% showed radiographic progression of the initial insult on post-4F-PCC head computed tomography, while only 11.1% progressed clinically. In-hospital mortality was 0%. There were no thromboembolic complications.


CONCLUSIONS
4F-PCC effectively reverses elevated INRs in trauma patients with warfarin-induced coagulopathy, with results lasting more than 48 hours after administration.


METHODS
Therapeutic study, level V.
From the Division of Trauma, Surgical Critical Care, Burns and Acute Care Surgery (A.E.B., L.K., L.N.G., A.M.S., R.C.), Department of Pharmacy (W.-T.H., K.B.), and Division of Neurosurgery (D.W.), University of California, San Diego, La Jolla, California.
Allison E
AE
Berndtson
Wan-Ting
WT
Huang
Kevin
K
Box
Leslie
L
Kobayashi
Laura N
LN
Godat
Alan M
AM
Smith
David
D
Weingarten
Raul
R
Coimbra
D000368:Aged; D001778:Blood Coagulation Disorders / Q000139:chemically induced* / Q000188:drug therapy*; D001779:Blood Coagulation Factors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D017277:Drug Approval; D005260:Female; D006801:Humans; D019934:International Normalized Ratio; D008297:Male; D012189:Retrospective Studies; D013916:Thrombelastography; D013997:Time Factors; D014193:Trauma Centers; D015599:Trauma Severity Indices; D014859:Warfarin / Q000009:adverse effects*
D001779:Blood Coagulation Factors; C025667:prothrombin complex concentrates; D014859:Warfarin