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

Primary Purpose

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

Status
Terminated
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Erythropoietin subcutaneously and Iron intravenously
Sponsored by
Catharina Ziekenhuis Eindhoven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart; Dysfunction Postoperative, Cardiac Surgery focused on measuring Blood transfusion, Erythropoietin, Iron suppletion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Catharina Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Erythropoietin Iron

Arm 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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 23, 2014
Last Updated
April 4, 2017
Sponsor
Catharina Ziekenhuis Eindhoven
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1. Study Identification

Unique Protocol Identification Number
NCT02210949
Brief Title
Pre-operative Treatment With Erythropoietin and Iron Supplement in Cardiac Surgery
Official Title
Pre-operative Treatment With Erythropoietin and Iron Supplement for Prevention of Perioperative Blood Transfusion in Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Low inclusion rate
Study Start Date
August 2014 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catharina Ziekenhuis Eindhoven

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart; Dysfunction Postoperative, Cardiac Surgery, Anemia, Iron-Deficiency
Keywords
Blood transfusion, Erythropoietin, Iron suppletion

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Erythropoietin Iron
Arm Type
Other
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Erythropoietin subcutaneously and Iron intravenously
Other Intervention Name(s)
Eprex, Ferinject
Intervention Description
Administration of Erythropoietin subcutaneously and administration of iron intravenously
Primary Outcome Measure Information:
Title
The number of patients who receive RBC transfusion perioperatively
Description
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.
Time Frame
1 day
Title
The number of patients who receive RBC transfusion perioperatively
Description
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.
Time Frame
3 days
Title
The number of patients who receive RBC transfusion perioperatively
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
To determine the degree of reduction in the mean number of RBC unit transfusions per patient.
Description
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.
Time Frame
30 days
Other Pre-specified Outcome Measures:
Title
Other general non specific outcome data after cardiac surgery
Description
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.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marius C Haanschoten, MD
Organizational Affiliation
Catharina Ziekenhuis Eindhoven the Netherlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
Catharina Hospital
City
Eindhoven
State/Province
N Brabant
ZIP/Postal Code
5602 ZA
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
20231104
Citation
van Straten AH, Kats S, Bekker MW, Verstappen F, ter Woorst JF, van Zundert AJ, Soliman Hamad MA. Risk factors for red blood cell transfusion after coronary artery bypass graft surgery. J Cardiothorac Vasc Anesth. 2010 Jun;24(3):413-7. doi: 10.1053/j.jvca.2010.01.001. Epub 2010 Mar 15.
Results Reference
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PubMed Identifier
16684074
Citation
Alghamdi AA, Albanna MJ, Guru V, Brister SJ. Does the use of erythropoietin reduce the risk of exposure to allogeneic blood transfusion in cardiac surgery? A systematic review and meta-analysis. J Card Surg. 2006 May-Jun;21(3):320-6. doi: 10.1111/j.1540-8191.2006.00241.x.
Results Reference
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PubMed Identifier
19815567
Citation
van Straten AH, Bekker MW, Soliman Hamad MA, van Zundert AA, Martens EJ, Schonberger JP, de Wolf AM. Transfusion of red blood cells: the impact on short-term and long-term survival after coronary artery bypass grafting, a ten-year follow-up. Interact Cardiovasc Thorac Surg. 2010 Jan;10(1):37-42. doi: 10.1510/icvts.2009.214551. Epub 2009 Oct 8.
Results Reference
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PubMed Identifier
22027621
Citation
Fox A. Recombinant human erythropoeitin: efficacy and safety considerations for maximizing blood conservation in cardiac surgery. Anesthesiology. 2011 Nov;115(5):912-4. doi: 10.1097/ALN.0b013e318231fd85. No abstract available.
Results Reference
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Pre-operative Treatment With Erythropoietin and Iron Supplement in Cardiac Surgery

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