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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2017-04-30

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.

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Erythropoietin subcutaneously and Iron intravenously

Intervention Type DRUG

Administration of Erythropoietin subcutaneously and administration of iron intravenously

Interventions

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Erythropoietin subcutaneously and Iron intravenously

Administration of Erythropoietin subcutaneously and administration of iron intravenously

Intervention Type DRUG

Other Intervention Names

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Eprex Ferinject

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No