Status:
TERMINATED
Algorithm-Guided Transfusions in Cardiac Surgery Patients for Reduction of Drainage Blood Losses
Lead Sponsor:
Michael Sander
Conditions:
Chest Tube Output
Allogeneic Blood Transfusions
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Cardiac surgery patients have a risk to need allogeneic blood transfusions that depends on several risk factors, e.g. the type of surgery, concomitant medication with anticoagulants, and postoperative...
Detailed Description
Cardiac surgery patients have a risk to need allogeneic blood transfusions that depends on several risk factors, e.g. the type of surgery, concomitant medication with anticoagulants, and postoperative...
Eligibility Criteria
Inclusion
- elective cardiac surgery patient requiring cardiopulmonary bypass
- moderate or high transfusion risk
- signed informed consent
Exclusion
- age \<18 or \>80 years
- known hemophilia
- known thrombophilia
- known thrombocytopathy
- hereditary or acquired coagulation disorder
- active endocarditis
- ejection fraction \<30%
- BSA \< 1.8 sqm
- planned aortic arch surgery
- preoperative thrombocytopenia \<150/nl
- underlying hemostaseological disease
- preoperative anemia
- liver cirrhosis Child B or higher
- preoperative creatinine \> 2mg/dl
- terminal renal insufficiency requiring dialysis
- vitamin k antagonists during 5 days prior to surgery
- pregnant or breast-feeding women
- known allergy against allogeneic blood products or coagulation factors
- refusal of blood transfusions
- any concomitant investigational agent or participation in another trial
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01402739
Start Date
August 1 2011
End Date
June 1 2015
Last Update
June 15 2015
Active Locations (1)
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1
Department of Anesthesiology CCM/CVK Charité Universitätsmedizin Berlin
Berlin, State of Berlin, Germany, 10117