A Trial of PROTHROMPLEX TOTAL for Reversal of Direct Oral Factor Xa Inhibitor-induced Anticoagulation
Status:
Not yet recruiting
Trial end date:
2023-06-30
Target enrollment:
Participant gender:
Summary
The aim of this study is to examine the potential of PROTHROMPLEX TOTAL compared to
investigator-assigned four-factor prothrombin complex concentrate (4F-PCC) as a part of SOC
for the reversal of anticoagulation in participants treated with Factor Xa inhibitors who
require urgent surgery/invasive procedure.
The participant will be randomized to PROTHROMPLEX TOTAL or investigator-assigned 4F-PCC as a
part of SOC prior to surgery.
Patients participating in this study will need to be hospitalized. They will also be
contacted (via telehealth/remote monitoring) 30 days after the surgery.