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

Phase 4

Terminated

• Conditions: Anemia, Iron-Deficiency; Heart; Dysfunction Postoperative, Cardiac Surgery
• Interventions: Drug: Erythropoietin subcutaneously and Iron intravenously

• Registration Number: NCT02210949
• Lead Sponsor: Catharina Ziekenhuis Eindhoven

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.

Study Timeline

• Study First Submitted: 2014-06-23
• Study Start: 2014-08
• Study First Submitted QC: 2014-08-05
• Study First Posted: 2014-08-07
• Status Verified: 2017-04
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Last Update Submitted: 2017-04-04
• Last Update Posted: 2017-04-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Erythropoietin Iron	Erythropoietin subcutaneously and Iron intravenously	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.

Primary Outcome Measures

Name	Time	Method
The number of patients who receive RBC transfusion perioperatively	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 Outcome Measures

Name	Time	Method
To determine the degree of reduction in the mean number of RBC unit transfusions per patient.	30 days	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.

Trial Locations

Locations (1)

Catharina Hospital; 🇳🇱 Eindhoven, N Brabant, Netherlands