Pre-operative Treatment With Erythropoietin and Iron Supplement for Prevention of Perioperative Blood Transfusion in Cardiac Surgery
Overview
- Phase
- Phase 4
- Intervention
- Erythropoietin subcutaneously and Iron intravenously
- Conditions
- Heart; Dysfunction Postoperative, Cardiac Surgery
- Sponsor
- Catharina Ziekenhuis Eindhoven
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- The number of patients who receive RBC transfusion perioperatively
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
Brief Summary
Pre-treatment of patients with erythropoietin subcutaneously and iron supplement intravenously, in order to create a clinical pathway to minimize transfusion of red blood cells in a selected group of cardiac patients with an increased risk for blood transfusions in our cardiac surgery program.
Detailed Description
Blood transfusion is identified as an independent predictor of early mortality after Coronary artery bypass grafting operations In addition, female gender, lower body surface area (BSA), low preoperative Hemoglobin (Hb), previous cardiac surgery, emergency operation and low preoperative creatinin clearance were found to be independent risk factors for receiving Red Blood Cells (RBC) units. We create a clinical pathway to reduce transfusion of red blood cells by pretreating patients with erythropoietin and iron to determine the reduction of number of patients who receive blood transfusion perioperatively. Also we want to investigate the decrease in the mean number of RBC units received per patient in the perioperative period.
Investigators
AHM van Straten
MD, PhD
Catharina Ziekenhuis Eindhoven
Eligibility Criteria
Inclusion Criteria
- •Undergoing isolated Coronary Artery Bypass Grafting operation or Aortic Valve Repair (AVR).
- •Preoperative Hb \< 7 mmol/l.
Exclusion Criteria
- •Off pump surgery.
- •Combination surgery.
- •Re-operation.
- •Emergency operation.
- •Patients with bleeding disturbances; e.g, hemophilia and patients with chronic liver disease.
- •Concomitant use of cyclosporine prior to, during or following surgery.
- •Female patients who are pregnant or planning to become pregnant.
Arms & Interventions
Erythropoietin Iron
Erythropoietin and iron: Administration of Erythropoietin (600 IU/kg (14.4 g/L)) twice weekly for three weeks . Administration of Iron (Ferinject (iron(III)carboxymaltose)) intravenously 1000 mg once.
Intervention: Erythropoietin subcutaneously and Iron intravenously
Outcomes
Primary Outcomes
The number of patients who receive RBC transfusion perioperatively
Time Frame: 30 days
To determine the reduction of the number of patients receiving blood transfusion the pre-treated group with erythropoietin and iron supplement compared to the control patients.
Secondary Outcomes
- To determine the degree of reduction in the mean number of RBC unit transfusions per patient.(30 days)