Complications Clinical Trial
Official title:
Effect of Intravenous Iron Supplementation in Reducing Allogenic Blood Transfusion and Improving Outcomes in Patients Undergoing CABG. A Prospective Randomized Trial
Verified date | January 2020 |
Source | Ain Shams University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | January 10, 2020 |
Est. primary completion date | January 6, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 52 Years to 73 Years |
Eligibility |
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 - |
Country | Name | City | State |
---|---|---|---|
Egypt | Ain Shams university | Cairo |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | haemoglobin concentration change | the change in the Hb concentration at baseline, intraoperative, at discharge and 1 week after discharge in non-anaemic patients undergoing cardiac surgery. | 1 week after discharge from hospital | |
Secondary | hospital stay | duration of hospital stay | 7 to 10 days |
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