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

Catharina Hospital

Status and phase: Terminated; Phase 4

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

Treatments: Drug: Erythropoietin subcutaneously and Iron intravenously

Study type: Interventional

Funder types: Other

Identifiers

NCT02210949

EPICSCZE14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Undergoing isolated Coronary Artery Bypass Grafting operation or Aortic Valve Repair (AVR).
2. Preoperative Hb < 7 mmol/l.

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.
7. Female patients who are pregnant or planning to become pregnant.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Erythropoietin Iron

Other group

Description:

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.

Treatment:

Drug: Erythropoietin subcutaneously and Iron intravenously