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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: Completed Phase 4 study, sponsored by HealthPartners Institute.
NCT03064035 is a Phase 4 study that has completed, run by HealthPartners Institute. The registered enrollment target is 79 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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
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 |
What the finished NCT03064035 record still lists
NCT03064035 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which 4-factor prothrombin complex concentrate (4FPCC) is the first listed.
NCT03064035 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03064035's enrollment target sits among peer trials
79 980th of 2000 higher than 1,019 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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