Effect of Intravenous Iron Supplementation in Reducing Allogenic Blood Transfusion

Early Phase 1

Completed

• Conditions: Complications
• Interventions: Other: placebo; Drug: Iron Isomaltoside 1000

• Registration Number: NCT04061655
• Lead Sponsor: Ain Shams University

Brief 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.

Detailed Description

A total of 80 patients will 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.

General anesthesia will the institutional standards and all surgeries will be performed by the same surgical team.Standardized monitoring will be applied.After median sternotomy,CPB will be established with 1500 ml crystalloid priming volume and mild hypothermia (32°C) with a Trillium Affinity oxygenator (Medtronic,Minneapolis, Minnesota, USA) and a Sarns CPB machine (Harrison, Mt. Clemens, Michigan, USA) at a flow rate of 2.6 lmin-1m-2.Myocardial protection will be done using cold blood cardioplegia at 20°C. During CPB, homologous donor packed red blood cells will be transfused if hemoglobin was less than 6.5 gdl-1.During bypass, anticoagulation for extracorporeal circulation was performed using heparin 300 U/kg administered into the right atrium. Acelite activated clotting time (ACT) greater than 400 was considered adequate for commencing CPB; if less, an additional dose of 100Uof heparin will be adminstered.CPB will be conducted using nonocclusive roller pumps, arterial line filtration ,membrane oxygenators, , and blood-enriched cold hyperkalemic arrest. Systemic hypothermia documented by an esophageal temperature of 32°C will be maintained during aortic cross clamping.After completion of CPB and removal of the arterial cannula, heparin will be neutralized with 1 mg of protamine sulfate adminstered for every 100U of heparin over a period of 15 minutes . Eventually, a second dose of protamine 50 mg will be given if ACT remained above baseline. All patients will be transferred to ICU after surgery.

Study Timeline

• Study First Submitted: 2019-08-17
• Study First Submitted QC: 2019-08-17
• Study First Posted: 2019-08-20
• Study Start: 2019-09-20
• Status Verified: 2020-01
• Primary Completion: 2020-01-06
• Study Completion: 2020-01-10
• Last Update Submitted: 2020-01-18
• Last Update Posted: 2020-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	Patients in the placebo group (n=40)received as a single-dose of saline (Natriumklorid 9 mg/ml; Fresenius Kabi, Copenhagen, Denmark) 100 ml infused over 15 min.
iron therapy group	Iron Isomaltoside 1000	Apatients (n= 40) received single dose intravenous infusions of iron isomaltoside 1000 mg over 15 min with a maximum single dose of 20 mg/kg.

Primary Outcome Measures

Name	Time	Method
haemoglobin concentration change	1 week after discharge from hospital	the change in the Hb concentration at baseline, intraoperative, at discharge and 1 week after discharge in non-anaemic patients undergoing cardiac surgery.

Secondary Outcome Measures

Name	Time	Method
hospital stay	7 to 10 days	duration of hospital stay

Trial Locations

Locations (1)

Ain Shams university; 🇪🇬 Cairo, Egypt