Pre-operative treatment with Erythropoietin and iron supplement for prevention of perioperative blood transfusion in cardiac surgery
- Conditions
- Patients (male and female) scheduled for coronary artery bypass grafting surgery (CABG) or single Aortic Valve replacement (AVR) on conventional cardiopulmonary bypass.Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2012-002076-14-NL
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
1. Age of 18 years or more undergoing isolated CABG or AVR
2. BSA < 1.7 m2. and preoperative Hb < 7.5 mmol/l
3. Preoperative Hb < 7 mmol/l.
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
Exclusion Criteria
1. Off pump surgery.
2. Combination surgery.
3. Re-operation.
4. Emergency operation.
5. Patients with bleeding disturbances; e.g, hemophilia and patients with chronic liver disease.
6. Concomitant use of cyclosporine prior to, during or following surgery.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Primary objective: To determine the reduction of blood transfusion in the coronary artery bypass graft patients in patients pre-treated with erythropoietin and iron supplement compared to the non-treated patients. We aim to reduce total blood transfusion with 50% in the pre-treated group. ;Secondary Objective: Secondary Objective: To determine the cost reduction on blood products in our program.;Primary end point(s): The use of blood products (mean number of transfused red blood cells units per patient).;Timepoint(s) of evaluation of this end point: Pre- and post-operative period during admission up to 30 days post-surgery
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Routine pre- and post-operative haematology parameters, such as hemoglobin and hematocrit will be collected. Moreover, early mortality and morbidity (presence of myocardial infarction, CVA, renal function disturbances) will be determined.;Timepoint(s) of evaluation of this end point: 30 days post-surgery