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

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ClinicalTrials.gov Identifier: NCT02210949
Recruitment Status : Terminated (Low inclusion rate)
First Posted : August 7, 2014
Last Update Posted : April 5, 2017
Sponsor:
Information provided by (Responsible Party):
AHM van Straten, Catharina Ziekenhuis Eindhoven

Study Description
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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.

Condition or disease Intervention/treatment Phase
Heart; Dysfunction Postoperative, Cardiac Surgery Anemia, Iron-Deficiency Drug: Erythropoietin subcutaneously and Iron intravenously Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pre-operative Treatment With Erythropoietin and Iron Supplement for Prevention of Perioperative Blood Transfusion in Cardiac Surgery
Actual Study Start Date : August 2014
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

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Arms and Interventions
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Arm Intervention/treatment
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:
  • Eprex
  • Ferinject


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02210949


Locations
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Netherlands
Catharina Hospital
Eindhoven, N Brabant, Netherlands, 5602 ZA
Sponsors and Collaborators
Catharina Ziekenhuis Eindhoven
Investigators
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Principal Investigator: Marius C Haanschoten, MD Catharina Ziekenhuis Eindhoven the Netherlands
More Information
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Publications:

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Responsible Party: AHM van Straten, MD, PhD, Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier: NCT02210949    
Other Study ID Numbers: EPICSCZE14
First Posted: August 7, 2014    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017
Keywords provided by AHM van Straten, Catharina Ziekenhuis Eindhoven:
Blood transfusion
Erythropoietin
Iron suppletion
Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
 Iron Metabolism Disorders
Metabolic Diseases
Epoetin Alfa
Hematinics