Intra-operative medication trial.
Conditions
Interventions
Group A will receive placebo
Group B will receive high dose aprotinin
Group C will receive tranexamic acid.
- All medications will be administered during surgery. Anesthetic and surgical procedures in all groups will be carried out according to standard care
- All patients will be observed until their discharge, during which time all measurements obtained during standard care will be recorded
- One blood monster preoperative and four blood monsters will be taken postoperatively to asses for protein concentrations related to SIRS.
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: Patients scheduled for first time, non-complex (one or two procedures) open heart surgery with the use of CPB.
Exclusion criteria
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 the 5 days before the operation; 8. Known bleeding disorder; 9. Pregnancy; 10. Scheduled for 3 or more procedures; 11. Emergency operations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Intraoperative and perioperative blood loss; 2. Intraoperative and perioperative use of blood products. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Rethoracotomies; 2. The total duration of each patient's stay in the operating room; 3. Length of stay in the ICU and hospital; 4. Development of SIRS/sepsis/MOF; 5. 30-day morbidity; 6. 30-day mortality; 7. Costs. | — |
Contacts
Public ContactR.J.M. Klautz
Leiden University Medical Center (LUMC), Department of CardioThoracic Surgery, room D6-53, P.O. Box 9600
Outcome results
None listed