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

Information source: Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Heart; Dysfunction Postoperative, Cardiac Surgery; Anemia, Iron-Deficiency

Intervention: Erythropoietin subcutaneously and Iron intravenously (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Catharina Ziekenhuis Eindhoven

Official(s) and/or principal investigator(s):
Marius C Haanschoten, MD, Principal Investigator, Affiliation: Catharina Ziekenhuis Eindhoven the Netherlands

Overall contact:
Marius C Haanschoten, MD, Phone: 0031402398500, Email: marco.haanschoten@catharinaziekenhuis.nl

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.

Clinical Details

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

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome:

The number of patients who receive RBC transfusion perioperatively

The number of patients who receive RBC transfusion perioperatively

The number of patients who receive RBC transfusion perioperatively

Secondary outcome: To determine the degree of reduction in the mean number of RBC unit transfusions per patient.

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Marius C Haanschoten, MD, Phone: 0031402398500, Email: marco.haanschoten@catharinaziekenhuis.nl

Catharina Hospital, Eindhoven, N Brabant 5602 ZA, Netherlands; Not yet recruiting
Bart HM van Straten, MD PhD, Phone: 0031402399111, Email: bart.v.starten@catharinaziekenhuis.nl
Alexander Bindels, MD PhD, Phone: 0031402399111, Email: alex.bindels@catharinazielkenhuis.nl
Marius C Haanschoten, MD, Principal Investigator
Additional Information

Related publications:

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.

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. Review.

van Straten AH, Bekker MW, Soliman Hamad MA, van Zundert AA, Martens EJ, Schönberger 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.

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.

Starting date: August 2014
Last updated: August 5, 2014

Page last updated: August 23, 2015

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