Pre-operative treatment with Erythropoietin and iron supplement for prevention of perioperative blood transfusion in cardiac surgery

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002076-14-NL

Enrollment

100

Registered

2014-01-13

Start date

2014-05-12

Completion date

Unknown

Last updated

2014-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients (male and female) scheduled for coronary artery bypass grafting surgery (CABG) or single Aortic Valve replacement (AVR) on conventional cardiopulmonary bypass.

Interventions

Trade Name: EPREX Product Name: EPREX Product Code: RVG33268 Pharmaceutical Form: Suspension for injection in pre-filled syringe INN or Proposed INN: EPOETIN ALFA CAS Number: 113427-24-0 Other descrip

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age of 18 years or more undergoing isolated CABG or AVR 2. BSA =65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026