Preserved platelet function during cardiopulmonary bypass with aprotinin in dual antiplatelet therapy.

Phase 2

Recruiting

• Conditions: Coronary Artery Bypass Grafting; coronary artery disease; single valve surgery; 10007593

• Registration Number: NL-OMON49829
• Lead Sponsor: Isala Klinieken

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 58

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

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 <45 (mL/min/1.73m2)
11. Sensitivity to any of the components of study medication.
12. Any indication that the restrictions or procedures of the study may not be
adhered to (e.g. an uncooperative attitude).
13. Any indication that the study restrictions, procedures, or consequences
therein have not been considered or understood, such that informed consent
cannot be convincingly given.
14. Multiple morbidities, with a notably constrained remaining length of life.

Study & Design

• Study Type: Interventional
• Study Design: Not specified