Effect of Intravenous Iron Supplementation in Reducing Allogenic Blood Transfusion
Condition: Complications
Study type: Interventional
Phase: Early Phase 1

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.
    

Intervention name(s): Iron Isomaltoside 1000; placebo
Intervention type(s): Drug; Other
Intervention description(s): 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.; 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.
Other intervention name(s): iron therapy
Intervention MeSH terms: Iron; Iron isomaltoside 1000
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: CABG; iron therapy; blood transfusion