Effect of Intravenous Iron Supplementation in Reducing Allogenic Blood Transfusion

• Status: Completed
• Trial end date: 2020-01-10
• Target enrollment: 0
• Participant gender: All

Summary

A total of 80 patients will be randomly allocated into 2 groups, group A and placebo group using concealed envelope method.Group A patients (n= 40)will receive single dose intravenous infusions of iron isomaltoside 1000 mg over 15 min with a maximum single dose of 20 mg/kg. Patients in the placebo group (n=40) will receive as a single-dose of saline (Natriumklorid 9 mg/ml; Fresenius Kabi, Copenhagen, Denmark) 100 ml infused over 15 min.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Treatments: Ferric Compounds; Iron; Iron isomaltoside 1000

Criteria

Inclusion Criteria:

• patients aged 52-73 years old

• ASA II/III

• elective CABG

• hemoglobin level at baseline for males >13.0 g/dl and for females >12.0 g/dl.

Exclusion Criteria:

• Patients with known hypersensitivity to iron sucrose

• history of hepatitis B or C or human immunodeficiency virus

• folate or vitamin B12deficiency, history of unstable angina,

• active severe infection

• suspicion of iron overload (ferritin > 300 μg/l ), or autologous blood transfusion in the previous month pregnancy and nursing impaired renal function defined by s-creatinine >150 μmol/L patients received any iron preparations in the previous month -