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

NCT02210949 | Terminated Phase 4

• 1 other identifier: EPICSCZE14
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Blood transfusion; Erythropoietin; Iron suppletion

Outcome Measures

Primary Outcomes (3)

• 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.

  1 day

• 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.

  3 days

• 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.

  30 days

Secondary Outcomes (1)

• To determine the degree of reduction in the mean number of RBC unit transfusions per patient.

  30 days

Other Outcomes (1)

• Other general non specific outcome data after cardiac surgery

  30 days

Study Arms (1)

Erythropoietin Iron

OTHER

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

Interventions

Erythropoietin subcutaneously and Iron intravenously DRUG

Administration of Erythropoietin subcutaneously and administration of iron intravenously

Also known as: Eprex, Ferinject

Erythropoietin Iron

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing isolated Coronary Artery Bypass Grafting operation or Aortic Valve Repair (AVR).
• Preoperative Hb \< 7 mmol/l.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Catharina Ziekenhuis Eindhoven: lead

Study Sites (1)

Catharina Hospital

Eindhoven, North Brabant, 5602 ZA, Netherlands

Location

Related Publications (4)

• 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.

  PMID: 20231104 BACKGROUND

• 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.

  PMID: 16684074 BACKGROUND

• 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.

  PMID: 19815567 BACKGROUND

• 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.

  PMID: 22027621 BACKGROUND

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Epoetin Alfa; ferric carboxymaltose

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Marius C Haanschoten, MD

  Catharina Ziekenhuis Eindhoven the Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 23, 2014
• First Posted: August 7, 2014
• Study Start: August 1, 2014
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: April 5, 2017

Record last verified: 2017-04

Locations

NL (1)