Status:
COMPLETED
High Yield Intraoperative, Autologous Platelet Apheresis
Lead Sponsor:
Duke University
Collaborating Sponsors:
Terumo BCT
Conditions:
Allogenic Transfusion of Platelets During Cardiac Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The overall aim is to reduce overall allogeneic transfusion requirements during cardiac surgery when compared to standard management. To evaluate this the investigators will test the hypothesis that ...
Eligibility Criteria
Inclusion
- All elective, aortic reconstruction surgery and other patients at high risk of receiving platelet transfusions such as: combined CABG/valve, more than one valve surgery via median sternotomy, left ventricular assist devise, and pulmonary thromboarterectomy with deep hypothermic circulatory arrest cases.
- Over 18 years of age
Exclusion
- renal disease (dialysis dependent, end-stage renal disease or a baseline Cr \>3mg/dl)
- known coagulopathy/bleeding tendency (such as von Willebrand disease)
- platelet count of \<150x109 /liter at baseline
- Hct \< 30%
- platelet inhibitory drugs within 5 days prior to surgery or Aspirin 325 mg within 48 hrs of surgery
- inability to provide written, informed consent
- patients receiving pre-operative parenteral, non-heparin anticoagulants will be excluded
- pregnancy is not an exclusion criterion for the study but, typically, pregnancy is a contraindication to elective cardiac surgery hence pregnant patients are unlikely to be encountered.
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT01819246
Start Date
January 1 2013
End Date
January 1 2015
Last Update
March 19 2015
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710