14 Clinical Trials for Various Conditions
This study will evaluate the establishment of anticoagulation ("re-anticoagulation") of subjects with edoxaban following reversal by PER977 and will identify a dose regimen of PER977 that reverses the effects of edoxaban for up to 21 hours.
Prospective assessment of vitamin K dependent coagulation factor levels after temporary warfarin reversal in participants with left ventricular assist devices (LAVD).
The objective of this study is to evaluate the safety, efficacy and efficiency of rapid anticoagulation reversal with protamine sulfate versus routine activated clotting time (ACT) monitoring in patients undergoing catheter based ablation of atrial fibrillation.
The goal of SOAR is to characterize the clinical and economic impact of clinicians' responses to major bleeding complications and pre-procedural concerns for bleeding risk in patients treated with oral anticoagulants (warfarin, anti-Xa orals, and anti-thrombin (IIa) orals) who present to the ED or in the hospital with acute illness or injury, with the eventual aim of informing the development of improved approaches to the management of OACs in the ED.
PER977 administration following a single dose of enoxaparin
Normal subjects will receive unfractionated heparin followed by a single dose of PER977 with dose escalation by cohort. Ten subjects enrolled in Cohort 4 will receive a single dose of PER977 followed by a one-week washout and then will receive unfractionated heparin followed by a single dose of PER977. The study will provide some insight into the doses that may be required to reverse anticoagulation induced by heparin.
A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of ciraparantag for reversal of anticoagulation induced by different anticoagulant drugs in generally healthy adults as measured primarily by an automated coagulometer device.
PER977 monotherapy and co-administration following 60 mg edoxaban will have an acceptable safety and tolerability profile with no impact on pro-coagulant biomarkers. A dose of PER977 that reverses the effects of edoxaban on the pharmacodynamic (PD) biomarkers (point of care prothrombin time \[PoC-PT\]), and/or secondary biomarkers (thromboelastography reaction time \[TEG-R\]) will be identified.
Post marketing observational study on safety of BALFAXAR vs. KCENTRA for Reversal of Vitamin K Antagonist Induced Anticoagulation in Adults Undergoing Urgent Surgery or Invasive Procedure
The goal of this study is to determine if a fixed dose of 4-factor prothrombin complex concentrate (4FPCC) is as effective as the current standard of care. 4FPCC is used to reverse the effects of warfarin when a patient has emergent bleeding. The investigators hope that this study will help doctors treat patients quicker in the future. In addition, it may be cheaper for patients and hospitals. This is the same medication the doctor would use to reverse warfarin's effects, but at a lower dose. Hypothesis: A fixed dose of 4FPCC will be comparable to FDA-approved variable dosing for reversal of warfarin-induced anticoagulation (defined as an international normalized ratio \[INR\] ≤ 1.5) in patients with an INR ≥2 experiencing an emergent bleed or requiring emergent surgery.
To demonstrate that the efficacy of OCTAPLEX as a reversal agent in patients under Vitamin K Antagonist (VKA) therapy with the need for urgent surgery with significant bleeding risk is clinically non-inferior to that Beriplex® P/N (Kcentra).
The purpose of this study was to evaluate the hemostatic efficacy of andexanet alfa (andexanet) in participants receiving a factor Xa (FXa) inhibitor (apixaban, rivaroxaban, edoxaban, enoxaparin) who were experiencing an acute major bleed. The safety of andexanet was also studied.
The purpose of this study is to evaluate the ability of Andexanet Alfa to reverse the anticoagulation effect of Rivaroxaban.
The purpose of this stuy is to evaluate the ability of Andexanet Alfa to reverse the anticoagulation effect of Apixaban.