Pre-operative Treatment With Erythropoietin and Iron Supplement in Cardiac Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pre-operative Treatment With Erythropoietin and Iron Supplement for Prevention of Perioperative Blood Transfusion in Cardiac Surgery

Conditions
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Heart; Dysfunction Postoperative, Cardiac Surgery, Anemia, Iron-Deficiency

Intervention / Treatment
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* Drug: Erythropoietin subcutaneously and Iron intravenously


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Erythropoietin Iron<br>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. | Drug: Erythropoietin subcutaneously and Iron intravenously<br>* Administration of Erythropoietin subcutaneously and administration of iron intravenously<br>* Other names: Ferinject;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients who receive RBC transfusion perioperatively | 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. | 1 day | 
| The number of patients who receive RBC transfusion perioperatively | 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. | 3 days | 
| The number of patients who receive RBC transfusion perioperatively | 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. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the degree of reduction in the mean number of RBC unit transfusions per patient. | In order to determine the degree of reduction in the mean number of RBC unit transfusions per patient. We count the units we need to give compared to the control group according to standard accepted postoperative levels Hb in our Hospital. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood transfusion, Erythropoietin, Iron suppletion