Fixed-dose Activated Versus Variable-dose Inactivated Prothrombin Complex Concentrate for Warfarin-associated Major Bleed
Launched by RUSH UNIVERSITY MEDICAL CENTER · Sep 29, 2015
Trial Information
Current as of June 04, 2025
Completed
Keywords
ClinConnect Summary
Warfarin, a vitamin K antagonist (VKA), is the most frequently prescribed oral anticoagulant. Warfarin-associated major hemorrhage occurs at a rate of 1.7% to 3.4% in routine clinical practice and warrants rapid reversal of anticoagulation by correcting supratherapeutic international normalized ratio (INR) values.
Warfarin inhibits synthesis of vitamin K dependent coagulation factors II, VII, IX, and X, and strategies for reversal of warfarin-associated coagulopathy are aimed at restoring deficient factors. Four-factor prothrombin complex concentrates (PCCs) contain the coagulation factors...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Pre-treatment INR lab value greater than 1.5
- • Receipt of treatment with a 4-factor PCC for INR normalization due to warfarin-associated major hemorrhage
- Exclusion Criteria:
- • Patients treated with a PCC for an urgent invasive procedure without active hemorrhage
- • Patients treated with PCC not taking a VKA
- • Unavailable pre- or post-treatment INR lab values
- • Pregnant patients
About Rush University Medical Center
Rush University Medical Center is a leading academic medical institution located in Chicago, Illinois, dedicated to advancing healthcare through innovative research and clinical trials. As a sponsor of numerous clinical studies, Rush focuses on translating scientific discoveries into effective treatments and improving patient outcomes across a variety of medical disciplines. With a commitment to excellence in patient care, education, and research, Rush leverages its state-of-the-art facilities and a robust network of specialists to conduct comprehensive trials that adhere to the highest ethical and regulatory standards. Through collaboration with a diverse patient population, Rush aims to enhance the understanding of diseases and develop novel therapeutic strategies.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Gary D Peksa, PharmD
Principal Investigator
Rush University Medical Center
Robert Mokszycki, PharmD
Principal Investigator
advocate christ medical center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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