Status:
COMPLETED
Effects of Ferinject® on Anemia and Transfusion Rates After Cardiac Surgery
Lead Sponsor:
St Joseph University, Beirut, Lebanon
Collaborating Sponsors:
Vifor Pharma
Saint-Joseph University
Conditions:
Anemia, Iron Deficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Several studies using new forms of intravenous iron showed that it is effective in treating perioperative anemia in orthopedic and digestive surgery. Effects of ferric carboxymaltose have not been ass...
Detailed Description
Anemia is very common in the perioperative of major surgery affecting about 30% of patients preoperatively and more than 80% postoperatively. Anemia is an independent risk factor of morbi-mortality. ...
Eligibility Criteria
Inclusion
- Adult patients admitted for elective cardiac surgery under cardiopulmonary bypass, with no exclusion criteria, and having signed an informed consent, will be enrolled in the study.
Exclusion
- Patients \< 18 years
- Urgent surgery
- Off-pump cardiac surgery
- Redo cardiac surgery
- Preoperative anemia (Hb \< 10g/l or Ht \< 30%)
- Transfusion within 72h preoperatively
- Pregnancy
- History of asthma or other specific allergies
- History of allergy to iron
- Acute infection
- Hepatic insufficiency
- Renal insufficiency (creatinine Clearance \< 30ml/min)
Key Trial Info
Start Date :
December 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 2 2021
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT03759964
Start Date
December 15 2018
End Date
January 2 2021
Last Update
October 11 2021
Active Locations (1)
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1
Hotel Dieu de France Hospital
Beirut, Lebanon, 166830