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Clinical Trials/EUCTR2012-002076-14-NL
EUCTR2012-002076-14-NL
Active, not recruiting
Not Applicable

Pre-operative treatment with Erythropoietin and iron supplement for prevention of perioperative blood transfusion in cardiac surgery

Not provided0 sites100 target enrollmentJanuary 13, 2014
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ConditionsPatients (male and female) scheduled for coronary artery bypass grafting surgery (CABG) or single Aortic Valve replacement (AVR) on conventional cardiopulmonary bypass.Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
DrugsEPREXFerinject

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patients (male and female) scheduled for coronary artery bypass grafting surgery (CABG) or single Aortic Valve replacement (AVR) on conventional cardiopulmonary bypass.
Sponsor
Not provided
Enrollment
100
Status
Active, not recruiting
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 13, 2014
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Not provided

Eligibility Criteria

Inclusion Criteria

  • •1\. Age of 18 years or more undergoing isolated CABG or AVR
  • •2\. BSA \< 1\.7 m2\. and preoperative Hb \< 7\.5 mmol/l
  • •3\. Preoperative Hb \< 7 mmol/l.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 100
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 100

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.

Outcomes

Primary Outcomes

Not specified

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