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

NACompletedINTERVENTIONAL
Enrollment

214

Participants

Timeline

Start Date

August 31, 2016

Primary Completion Date

May 7, 2020

Study Completion Date

May 7, 2020

Conditions
Complex Valvular Heart Surgery
Interventions
DRUG

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.

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.

Trial Locations (1)

03722

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

All Listed Sponsors
lead

Yonsei University

OTHER

NCT02862665 - Effect of Perioperative Iron Isomaltoside 1000 Administration on Transfusion Requirements in Patients Undergoing Complex Valvular Heart Surgery: a Randomized Clinical Trial | Biotech Hunter | Biotech Hunter