Effect of Perioperative Iron Isomaltoside 1000 Administration on Transfusion Requirements in Patients Undergoing Complex Valvular Heart Surgery: a Randomized Clinical Trial

Yonsei University

Status: Completed

Conditions: Complex Valvular Heart Surgery

Treatments: Drug: normal saline 100 ml; Drug: iron isomaltoside 1000 (Monofer®)

Study type: Interventional

Funder types: Other

Identifiers

NCT02862665

4-2016-0502

Details and patient eligibility

About

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.

Enrollment: 214 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. the patients undergoing redo cardiac surgery or complex valvular heart surgery with cardiopulmonary bypass
2. tha age ≥19 yrs old.
3. the patients who are willing to provide written informed consent

Exclusion criteria

1. having preoperative anemia (Hb <9 g/dl for women, Hb <10 g/dl for men)
2. preoperative erythropoietin treatment within four weeks before surgery
3. redo cardiac operation due to preoperative paravalvular leakage
4. known hypersensitivity to any excipients in the investigational drug products
5. aplastic anemia
6. the patients who stay more than 48 hours in the intensive care unit preoperatively due to heart failure or other major complication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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214 participants in 2 patient groups, including a placebo group

IV iron

Experimental group

Description:

The patients will receive iron isomaltoside 1000 (Monofer®) as an i.v. infusion of 1000 mg (diluted with normal saline, 10 mg/ml) twice; 3 days before surgery and 3 days after surgery. They will receive iron isomaltoside 1000 (Monofer®) 1000 mg over 15 min.

Treatment:

Drug: iron isomaltoside 1000 (Monofer®)

Control

Placebo Comparator group

Description:

The patients will receive normal saline 100 ml as an i.v. infusion twice; 3 days before surgery and 3 days after surgery. They will receive normal saline 100 ml over 15 min.

Treatment:

Drug: normal saline 100 ml