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NCT03064035 · ClinicalTrials.gov registry record · Phase 4
Fixed Versus Variable Dosing of 4-factor Prothrombin Complex Concentrate for Emergent Warfarin Reversal
A Phase 4 study, sponsored by HealthPartners Institute.
- Completed
- Registry status
- Phase 4
- Development phase
- 79
- Enrollment target
NCT03064035 is a Phase 4 study that has completed, run by HealthPartners Institute. The registered enrollment target is 79 participants.
The verdict
NCT03064035, a Phase 4 study, has completed, sponsored by HealthPartners Institute.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 79 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG 4-factor prothrombin complex concentrate (4FPCC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2017-04-05 |
| Est. Completion | 2019-04-24 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03064035
The ClinicalTrials.gov registry entry for NCT03064035 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 79 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is HealthPartners Institute, which has 146 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which 4-factor prothrombin complex concentrate (4FPCC) is the first listed.
NCT03064035 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03064035 about?
NCT03064035 is a clinical study titled "Fixed Versus Variable Dosing of 4-factor Prothrombin Complex Concentrate for Emergent Warfarin Reversal". 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 ...
What is the current status of trial NCT03064035?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 79 participants. The study started on 2017-04-05. Estimated completion is 2019-04-24.
What interventions are being tested in trial NCT03064035?
The interventions under investigation include: 4-factor prothrombin complex concentrate (4FPCC) (DRUG).
Who is sponsoring clinical trial NCT03064035?
This trial is sponsored by HealthPartners Institute, which has 146 total clinical trials registered on ClinicalTrials.gov.
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