Status:
COMPLETED
Management of Bleeding Following Cardiopulmonary Bypass
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
University of Texas Southwestern Medical Center
Johns Hopkins University
Conditions:
Hemorrhage
Cardiopulmonary Bypass
Eligibility:
All Genders
Up to 75 years
Brief Summary
We believe ongoing bleeding during complex cardiac surgery can be accurately measured and that administration of a specific blood product replacement strategy designed to optimally slow or stop the bl...
Eligibility Criteria
Inclusion
- Eligible male and female patients will include those who are over 18 kg (identified as the lower inclusion threshold so as to standardize CPB circuit dilution) and less than 75 years old (to limit excessive stroke risk) and at theoretically increased risk for excessive bleeding following cardiopulmonary bypass, including patients:
- undergoing repeat sternotomy, or
- undergoing combined procedures (i.e. - valve and coronary artery surgery), or
- undergoing multiple valve surgery, or
- undergoing aortic root replacement with/without deep hypothermic circulatory arrest, or
- undergoing complex congenital cardiac surgery
Exclusion
- Ineligible patients include those:
- with known coagulation factor deficiency, or
- refusing to receive donor blood products if necessary, or
- undergoing emergency surgery, or
- undergoing their first coronary artery bypass surgery or their first valve repair/replacement, or
- with history of previous stroke or other significant thromboembolic event within 6 months (such as pulmonary embolism, valve obstruction \[if not replacing this valve in upcoming operation\], renal vein thrombosis, acute MI, DVT ), or
- with known thrombophilia, or
- with active infection (bacteremia, sepsis, endocarditis, meningitis, urinary tract infection, cholecystitis, cellulitis, pneumonia)
- pregnant, or
- weight \> 150 kg or \< 18 kg
Key Trial Info
Start Date :
April 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00672516
Start Date
April 1 2008
End Date
May 1 2009
Last Update
May 28 2015
Active Locations (1)
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1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390-8894