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NCT01300286 · ClinicalTrials.gov registry record · Phase 4
Open Label Use Of RiaStap During Aortic Reconstruction
A Phase 4 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 4
- Development phase
- 23
- Enrollment target
NCT01300286: Completed Phase 4 study, sponsored by Duke University.
NCT01300286 is a Phase 4 study that has completed, run by Duke University. The registered enrollment target is 23 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01300286, a Phase 4 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 23 participants
- Enrollment target
Study Summary
The overall purpose of this study is to administer fibrinogen concentrate (RiaSTAP, CSL Behring, Marburg, Germany) with the goal of treating coagulopathic bleeding by improving hemostasis thereby reducing overall blood product transfusion after separation from cardiopulmonary bypass following aortic reconstructive surgery. With the current sample size this is a pilot study and in effect will determine the fibrinogen level response to fibrinogen concentrate administered during aortic reconstructive surgery. It will be underpowered to detect reduction in bleeding but comparison to historical controls will be included as a secondary outcome.
Primary Outcome
Fibrinogen levels will be assessed only at the timepoints listed in the timeframe and for a maximum of 24 hours.
Interventions
- DRUG RiaSTAP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2010-12 |
| Est. Completion | 2012-12 |
| Phase | Phase 4 |
What the finished NCT01300286 record still lists
NCT01300286 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which RiaSTAP is the first listed.
NCT01300286 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01300286 about?
NCT01300286 is a clinical study titled "Open Label Use Of RiaStap During Aortic Reconstruction". The overall purpose of this study is to administer fibrinogen concentrate (RiaSTAP, CSL Behring, Marburg, Germany) with the goal of treating coagulopathic bleeding by improving hemostasis thereby reducing overall blood product transfusion after separation from cardiopulmonary bypass following aortic...
What is the current status of trial NCT01300286?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 23 participants. The study started on 2010-12. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01300286?
The interventions under investigation include: RiaSTAP (DRUG).
Who is sponsoring clinical trial NCT01300286?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01300286's enrollment target sits among peer trials
23 1725th of 2000 higher than 270 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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