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

Anemia, Iron-Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02210949
• Other study ID #: EPICSCZE14
• Status: Terminated
• Phase: Phase 4
• First received: June 23, 2014
• Last updated: April 4, 2017
• Start date: August 2014
• Est. completion date: April 2017

Study information

• Verified date: April 2017
• Source: Catharina Ziekenhuis Eindhoven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Erythropoietin subcutaneously and Iron intravenously
Administration of Erythropoietin subcutaneously and administration of iron intravenously

Locations

Country	Name	City	State
Netherlands	Catharina Hospital	Eindhoven	N Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Catharina Ziekenhuis Eindhoven

Country where clinical trial is conducted

Netherlands, 

References & Publications (4)

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. — View 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. — View Citation

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Other general non specific outcome data after cardiac surgery	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.	30 days
Primary	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
Primary	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
Primary	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	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.	30 days