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

April 4, 2017 updated by: AHM van Straten, Catharina Ziekenhuis Eindhoven

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • N Brabant
      • Eindhoven, N Brabant, Netherlands, 5602 ZA
        • Catharina hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Drug: Erythropoietin subcutaneously and Iron intravenously
Administration of Erythropoietin subcutaneously and administration of iron intravenously
Other Names:
  • Ferinject
  • Eprex

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Other general non specific outcome data after cardiac surgery
Time Frame: 30 days
Moreover, early mortality and morbidity (postoperative blood loss, presence of myocardial infarction, Cerebral vascular accident (CVA), renal function disturbances) are always collected in the computerized database of the department of Cardiothoracic Surgery. These parameters will be used in the present study as well.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catharina Ziekenhuis Eindhoven

Investigators

  • Principal Investigator: Marius C Haanschoten, MD, Catharina Ziekenhuis Eindhoven the Netherlands

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

June 23, 2014

First Submitted That Met QC Criteria

August 5, 2014

First Posted (Estimate)

August 7, 2014

Study Record Updates

Last Update Posted (Actual)

April 5, 2017

Last Update Submitted That Met QC Criteria

April 4, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPICSCZE14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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