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

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02210949

Enrollment

Registered

2014-08-07

Start date

2014-08-31

Completion date

2017-04-30

Last updated

2017-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Blood transfusion, Erythropoietin, Iron suppletion

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.

Interventions

DRUGErythropoietin subcutaneously and Iron intravenously

Administration of Erythropoietin subcutaneously and administration of iron intravenously

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
The number of patients who receive RBC transfusion perioperatively	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.

Secondary

Measure	Time frame	Description
To determine the degree of reduction in the mean number of RBC unit transfusions per patient.	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

Measure	Time frame	Description
Other general non specific outcome data after cardiac surgery	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.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026