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Effect of Perioperative Iron Isomaltoside 1000 Administration on Transfusion Requirements in Patients Undergoing Complex Valvular Heart Surgery: a Randomized Clinical Trial
In complex cardiac surgery with prolonged cardiopulmonary bypass, allogeneic blood products transfusions are often necessary to control intraoperative and postoperative bleeding. Furthermore, approximately 50% of all patients undergoing cardiac surgery are anemic before surgery, and patients with normal hemoglobin level may become anemic during and/or after surgery. Perioperative transfusion carries risks far beyond transmission of infection and has been demonstrated to be associated with adverse outcomes related to postoperative pulmonary complications, decreased renal function and increased mortality. Thus, the important of blood conservation stratigies to minimize transfusion is being increasingly emphasized. In recent trial by Johansson and colleagues, they concluded that the perioperative administration of intravenous iron isomaltoside 1000 increased the hemoglobin level and prevented anemia 4 weeks after cardiac surgery. Therefore, perioperative iron isomaltoside 1000 administration among the patients undergoing complex valvular heart surgery could reduce not only the perioperative allogeneic transfusion but also the incidence of postoperative adverse events. The aim of this study is to examine the effect of perioperative iron isomaltoside 1000 administration on transfusion requirements in patients undergoing complex valvular heart surgery.
Details
| Lead sponsor | Yonsei University |
|---|---|
| Phase | NA |
| Status | COMPLETED |
| Enrolment | 214 |
| Start date | 2016-08 |
| Completion | 2020-05-07 |
Conditions
- Complex Valvular Heart Surgery
Interventions
- iron isomaltoside 1000 (Monofer®)
- normal saline 100 ml
Primary outcomes
- the proportion of patients who need blood transfusion — patients will be followed for the duration of hospital stay, an expected average of 10 days after surgery
Investigator will assess the number of patients in each group who will need blood transfusion during hospital stays, and evaluate the effect of iron isomaltoside 1000 (Monofer®) on perioperative blood transfusion.
Countries
South Korea