Clinical trial NCT02862665: Effect of Perioperative Iron Isomaltoside 1000 Administration on Transfusion Requirements in Patients Undergoing Complex Valvular Heart Surgery: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complex Valvular Heart Surgery
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-08-11
Enrollment: 214
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: the proportion of patients who need blood transfusion
timeFrame: patients will be followed for the duration of hospital stay, an expected average of 10 days after surgery
Secondary outcomes:
measure: the proportion of patients who will experience postoperative adverse events
timeFrame: within the first 20 days after surgery. (plus or minus 3 days)
measure: the plasma hepcidin concentrations of patients
timeFrame: before the investigational drug i.v. infusion; 3 days before surgery and 3 days after surgery
measure: the plasma EPO (erythropoietin) concentrations of patients
timeFrame: before the investigational drug i.v. infusion; 3 days before surgery and 3 days after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Thoracic and Cardiovascular Surgery, Cardiovascular Research Institute, Yonsei University College of Medicine
Study officials:
References:
citation: 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.