Impact of the analgesic drug dipyrone (metamizole) on the antiplatelet effect of aspirin in patients after cardiac surgyer
- Conditions
- Antithrombotic therapy after surgical replacement of stenotic heart valve by a bioprosthesis or mitral valve repairTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2018-000017-20-DE
- Lead Sponsor
- niversitäts-Herzzentrum Freiburg • Bad Krozingen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 150
-Clinical indication for surgical replacement of the stenotic aortic valve by a bioprosthesis without concomitant CABG or surgical mitral valve repair
-Age > 50years
-Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 135
-Re-do heart surgery
-Indication for oral anticoagulation
-Known disorders of coagulation
-Chronic hepatic disease
-Chronic alcohol abuse
-Known malnutrition status
-Creatine clearance <30 ml7Min (CKD-EPI-formula)
-End-stage renal disease requring hemodialysis
-Known hematological disorders
-Peri-or postoperative transfusion of platelets
-Treatment with aspirin within 10 days prior to surgery
-Positive result in pregnancy in urine testing in female pre-menopausal patients
-Participation in any interventional study according to German Drug Law (AMG) or Medicinal Device Law (MPG) within 30 days before enrollment in this study
-Known hypersensitivity to dipyrone (metamizole) or paracetamol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method