Open Label Use Of RiaStap During Aortic Reconstruction
Completed · Phase 4
Conditions studied: Coagulopathic Bleeding
In brief
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.
Key facts
- Study ID
- NCT01300286
- Run by
- Duke University
- People needed
- 23
- Starts
- 2010-12-01
- Expected to finish
- 2012-12-01
- Last updated by the study team
- 2014-12-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Elective, adult aortic reconstruction involving a hemi-arch replacement at DUMC.
You may not qualify if…
- Concomitant procedures such as CABG , stents (within the last 3 years), refusal of blood transfusion, recent MI (within the last 3 months), pregnancy, INR > 1.1, platelet inhibitor drugs within 5 days of surgery (aspirin 325 mg within 48 hours of surgery), platelet count < 150,000, age <18 years, inability to obtain written informed consent, known coagulopathy including a history of recent coumadin therapy.
Where it is running
- Duke University Medical Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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