The clinical and economic effectiveness of high-dose aprotinin and tranexamic acid in patients undergoing first time open-heart surgery: a single-centre, double blind, prospective, randomised, placebo-controlled trial
Completed
- Conditions
- Heart surgery, Cardiopulmonary Bypass (CPB), bleedingSurgeryHeart surgery
- Registration Number
- ISRCTN00157697
- Lead Sponsor
- eiden University Medical Centre (LUMC) (Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
Patients scheduled for first time, non-complex (one or two procedures) open heart surgery with the use of Cardiopulmonary Bypass (CPB).
Exclusion Criteria
1. Less than 18 years old
2. Previous sternotomy
3. Previous aprotinin therapy
4. Known or suspected allergy to aprotinin
5. Refusal to receive blood transfusion
6. Abnormal perioperative coagulation profile for reasons other than anticoagulant therapy
7. Treatment with antiplatelet agents within five days of the operation
8. Known bleeding disorder
9. Pregnancy
10. Scheduled for three or more procedures
11. Emergency operations
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Intraoperative and perioperative blood loss<br>2. Intraoperative and perioperative use of blood products
- Secondary Outcome Measures
Name Time Method 1. Rethoracotomies<br>2. The total duration of each patient's stay in the operating room<br>3. Length of stay in the Intensive Care Unit (ICU) and hospital<br>4. Development of SIRS/sepsis/Multiple Organ Failure (MOF)<br>5. 30-day morbidity<br>6. 30-day mortality<br>7. Costs