Clinical trial NCT02210949: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Heart; Dysfunction Postoperative, Cardiac Surgery
Anemia, Iron-Deficiency
Keywords: Blood transfusion
Erythropoietin
Iron suppletion
Lead sponsor: Catharina Ziekenhuis Eindhoven
Sponsor class: OTHER
First posted: 2014-08-07
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: The number of patients who receive RBC transfusion perioperatively
timeFrame: 1 day
measure: The number of patients who receive RBC transfusion perioperatively
timeFrame: 3 days
measure: The number of patients who receive RBC transfusion perioperatively
timeFrame: 30 days
Secondary outcomes:
measure: To determine the degree of reduction in the mean number of RBC unit transfusions per patient.
timeFrame: 30 days
Other outcomes:
measure: Other general non specific outcome data after cardiac surgery
timeFrame: 30 days
Locations:
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
state: N Brabant
Study officials:
affiliation: Catharina Ziekenhuis Eindhoven the Netherlands
name: Marius C Haanschoten, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.