Completed

NCT Number: NCT02862665

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.

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Key information

Conditions

Complex Valvular Heart Surgery

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Seoul, 03722, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

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.

Primary outcomes

the proportion of patients who need blood transfusion

Time frame: 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.

Secondary outcomes

the proportion of patients who will experience postoperative adverse events

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

Investigator will assess the number of patients in each group who will experience postoperative adverse events (death, atrial fibrillation, reoperation, wound infection, acute kidney injury, permanent stroke, prolonged mechanical ventilation or postoperative myocardial infarction) within the first 20 days after surgery, and evaluate the effect of iron isomaltoside 1000 (Monofer®) on the occurrence of any postoperative adverse events.
the plasma hepcidin concentrations of patients

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

Investigator will assess the plasma hepcidin concentrations before the investigational drug i.v. infusion; 3 days before surgery and 3 days after surgery, and evaluate the association between the plasma hepcidin concentrations and the effect of iron isomaltoside 1000 (Monofer®) or the occurrence of any postoperative adverse events.
the plasma EPO (erythropoietin) concentrations of patients

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

Investigator will assess the plasma EPO concentrations before the investigational drug i.v. infusion; 3 days before surgery and 3 days after surgery, and evaluate the association between the plasma EPO concentrations and the effect of iron isomaltoside 1000 (Monofer®) or the occurrence of any postoperative adverse events.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2016
Primary completion: 2020
Study completion: 2020
First posted: Aug 11, 2016
Registry last updated: Aug 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.