Hemorrhage Clinical Trial
— kcentraOfficial title:
A Prospective, Randomized Study of Fixed Versus Variable Dosing of 4-factor Prothrombin Complex Concentrate for Emergent Warfarin Reversal at a Large Tertiary Care Medical Center
Verified date | June 2019 |
Source | HealthPartners Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 79 |
Est. completion date | April 24, 2019 |
Est. primary completion date | April 17, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 125 Years |
Eligibility | Inclusion Criteria: - Chronic anticoagulation with warfarin and initial INR =2 - Emergent bleeding (i.e. intracranial hemorrhage, gastrointestinal hemorrhage, urgent invasive procedures, etc.) or urgent surgery requiring reversal of INR to =1.5 Exclusion Criteria: - Younger than 18 years of age - History of heparin-induced thrombocytopenia (HIT) - Patients without initial or post-administration INR readings - Patients with an initial INR <2 - Pregnant patients - Prisoners |
Country | Name | City | State |
---|---|---|---|
United States | Regions Hospital | Saint Paul | Minnesota |
Lead Sponsor | Collaborator |
---|---|
HealthPartners Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants Who Demonstrated Significant Reversal of INR Within 15 Minutes | To evaluate whether fixed dose 4FPCC is acceptably comparable to variable dosing with respect to anticoagulation reversal, as defined by a targeted INR of =1.5 | 15 minutes | |
Secondary | Number of Participants With a Thromboembolic Event | Study patients will be followed post-administration of 4FPCC for thromboembolic events such as deep vein thrombosis, pulmonary embolism, ischemic stroke or transient ischemic event, or myocardial infarction. | up to 7 days post administration of 4FPCC | |
Secondary | Total Cost of Dosing Strategy | Cost outcomes will be assessed for all study patients and compared by dosing assignment. Cost of treatment was assessed based on the amount of 4FPCC doses administered during admission, using the study-contemporary rate of $1.57/unit | Hospital Stay, Up to 6 months |
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