Objective: During cardiac surgery, use of cardiac pulmonary bypass and blood loss cause an increase in allogeneic blood transfusions, which are associated with morbidity and mortality. This study evaluated a possible reduction in red blood cell (RBC) transfusion units after open heart surgery following pre-operative ferric carboxymaltose treatment.
Methods: A double blind randomized trial performed between Oct 2016 and Nov 2019. A total of 192 non-anemic patients underwent on-pump cardiac surgery were enrolled and randomly assigned into two groups. Study group, (n=98) received iron supplement 1000 mg ferric carboxymaltose (Ferinject) intravenous. Group II (n=94) received intravenous placebo, both within 1-3 days perioperative. Data was collected pre-operatively, at 1-4 post-operative day, and up to 2 months later. Primary outcome was the number of RBC transfusions during first 4 post-operative days.
Results: Baseline clinical and demographic characteristics and surgical procedure were similar in both groups. N=167 (86%) patients had low EUROSCORE II (<4), similar in both groups.
A significant reduction in RBC transfusion units was documented in Study group, mean of 0.3±0.9 vs 1.6±4.5 blood units in Placebo group, during the first 4 post-operative days (p=0.006).
The number of patients receiving RBC transfusion in Study group as compared to Placebo group was 19 VS 34 respectively (19% vs 36%) OR 0.42] 95% CI 0.22-0.88] p=0.01).
Although the number of RBC transfusion units was greater in Placebo group, the mean of hemoglobin concentration at post-operative day 4 for this group was 9.3 g/dl VS 9.7 g/dl in Study group (p=0.03).
At 60 days postoperative mean hemoglobin concentration was 11.8 g/dl (±1.5) in Placebo group VS 12.6 g/dl (±1.4) in Study group (p=0.012).
Conclusion: In non-anemic patients undergoing on-pump cardiac surgery, pre-operative treatment with single dose Ferinject within 1-3 days prior to surgery, significantly reduced the number of RBC transfusion units.