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

NCT ID: NCT02862665

Last Updated: 2020-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 214 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2020-05-07

Brief Summary

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.

Conditions

Complex Valvular Heart Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

IV iron

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.

Group Type: EXPERIMENTAL

iron isomaltoside 1000 (Monofer®)

Intervention Type: DRUG

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.

Control

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.

Group Type: PLACEBO_COMPARATOR

normal saline 100 ml

Intervention Type: DRUG

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.

Interventions

iron isomaltoside 1000 (Monofer®)

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.

Intervention Type: DRUG

normal saline 100 ml

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Thoracic and Cardiovascular Surgery, Cardiovascular Research Institute, Yonsei University College of Medicine

Seoul, , South Korea

Countries

South Korea

References

Lee SH, Shim JK, Soh S, Song JW, Chang BC, Lee S, Kwak YL. The effect of perioperative intravenously administered iron isomaltoside 1000 (Monofer(R)) on transfusion requirements for patients undergoing complex valvular heart surgery: study protocol for a randomized controlled trial. Trials. 2018 Jul 4;19(1):350. doi: 10.1186/s13063-018-2545-3.

Reference Type: DERIVED

PMID: 29973224 (View on PubMed)

Other Identifiers

4-2016-0502

Identifier Type: -

Identifier Source: org_study_id