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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 is a Phase 4 study that has completed, run by Duke University. The registered enrollment target is 23 participants.
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.
Interventions
- DRUG RiaSTAP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2010-12 |
| Est. Completion | 2012-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01300286
The ClinicalTrials.gov registry entry for NCT01300286 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which RiaSTAP is the first listed.
NCT01300286 reports 0 study locations.
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.
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