Coronary Artery Bypass Grafting coronary artery disease single valve surgery
Conditions
Interventions
6.1 Description of study medication
Aprotinin.
Aprotinine is classified as an antihaemorragic drug subclass, protease
inhibitor, ATC-code B02AB01.
Aprotinin is a non-specific serine protease inhibi
Sponsors
Isala Klinieken
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Eighteen years of age or older. 2. Undergoing elective on-pump coronary artery bypass surgery. 3. Use of a combination of aspirin and clopidogrel until at least 3 days prior to surgery
Exclusion criteria
Exclusion criteria: 1. Positive pregnancy test, pregnancy or lactation. 2. Women of child-bearing age not using a medically approved method of contraception during the study. 3. Undergoing an emergency operation. 4. Proof or suspicion of a congenital or acquired coagulation disorder (e.g. VWD or via severe liver disease). 5. Apoplexy in the 2 months preceding study surgery. 6. Manifest venous or arterial thrombosis. 7. Medication: o Tirofiban administration in the 2 days preceding surgery. o INR >1.4 if on coumadines. 8. Participation in another clinical study in the 4 weeks preceding this study. 9. Having received aprotinin in the last 2 months, in the absence of a IgG antibody test 10. Renal dysfunction, defined as eGFR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 7.1 Primary efficacy endpoint 1. Postoperative blood loss measured as drain production blood loss in ml between chest closure and 12 hours after surgery, or until drain removal if earlier. | — |
Secondary
| Measure | Time frame |
|---|---|
| 7.2 Secondary efficacy endpoints 1. Postoperative blood loss, measured as blood loss at the ICU between closure of chest and: • 1st hour • 2nd hour • 3rd hour • 24th hours • At the actual time of chest tube removal. 2. Bleeding class defined by the Universal Definition of Postoperative Bleeding 19 3. Number of units of allogenic blood products (platelets + FFP + RBCs) administered to subjects, between administration of study medication and closure of chest 4. Number of units of allogenic blood products (platelets + FFP + RBCs) administered to subjects, between administration of study medication and 24 hours thereafter. 5. Number of units of allogenic blood products (platelets + FFP + RBCs) administered to subjects, from admission to the ICU to discharge to the ward. 6. Number of units of fibrinogen, PCC or Novoseven given in the peri- and postoperative period. 7. Duration of post CPB phase, from infusion of study medication to transfer to ICU 8. Ventilation-time in hours during ICU stay. 9. Duration of stay in hours in the ICU following last suture of the initial surgery. 10. Duration of hospital stay in hours following last suture of the initial surgery. 11. Proportion of subjects that receive a follow-on surgery to correct unacceptable bleeding within 7 days of last suture. 12. Wound, sternal or other types of infection. 13. Major clinical events: o Mortality at 30 days post-surgery o MACE (major adverse cardiac event) o Cerebrovascular accident/ transient ischemic attack o Renal failure, defined as need for dialysis therapy o Venous thromboembolism/ pulmonary embolism o Allergic or other systemic reaction to study medication 14. Total costs of the procedure are calculated from data generated by the hospital administration and are composed of o OR time o Days in the ICU o Total days in hospital o Consumption of blood products and hemostatic agents. o Use of additional medical treatment e.g. dialysis | — |
Countries
Netherlands
Outcome results
None listed