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

NCT02862665 | Completed

• 1 other identifier: 4-2016-0502
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• the proportion of patients who need blood transfusion

  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.

  patients will be followed for the duration of hospital stay, an expected average of 10 days after surgery

Secondary Outcomes (3)

• the proportion of patients who will experience postoperative adverse events

  within the first 20 days after surgery. (plus or minus 3 days)

• the plasma hepcidin concentrations of patients

  before the investigational drug i.v. infusion; 3 days before surgery and 3 days after surgery

• the plasma EPO (erythropoietin) concentrations of patients

  before the investigational drug i.v. infusion; 3 days before surgery and 3 days after surgery

Study Arms (2)

IV iron

EXPERIMENTAL

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.

Drug: iron isomaltoside 1000 (Monofer®)

Control

PLACEBO COMPARATOR

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.

Drug: normal saline 100 ml

Interventions

iron isomaltoside 1000 (Monofer®) 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.

IV iron

normal saline 100 ml 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.

Control

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, 03722, South Korea

Location

Related Publications (1)

• 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.

  PMID: 29973224 DERIVED

MeSH Terms

Interventions

iron isomaltoside 1000; Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2016
• First Posted: August 11, 2016
• Study Start: August 1, 2016
• Primary Completion: May 7, 2020
• Study Completion: May 7, 2020
• Last Updated: August 18, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)