The effect of perioperative intravenously administered iron isomaltoside 1000 (Monofer®) on transfusion requirements for patients undergoing complex valvular heart surgery: Study protocol for a randomized controlled trial

Seung Hyun Lee, Jae Kwang Shim, Sarah Soh, Jong Wook Song, Byung Chul Chang, Sak Lee, Young Lan Kwak

Research output: Contribution to journalArticle

Abstract

Background: Anemia is a frequent complication after cardiac surgery especially following reoperation due to previous prosthetic valve failure or multiple valve surgery (including combined coronary artery bypass grafting). This trial explores whether intravenously administered iron isomaltoside 1000 (Monofer®) results in better clinical outcomes in patients undergoing complex heart valve surgery who are expected to receive transfusion. Methods/design: In this prospective, single-center, double-blinded, randomized controlled trial, 214 patients undergoing reoperation or multiple valve surgery are randomly allocated to either the iron isomaltoside 1000 (IVFe) or the control group from August 2016 to August 2018. The IVFe group receives iron isomaltoside 1000 mg (maximum dose 20 mg/kg) intravenously 3 days before and after the surgery. The control group receives an equivalent volume of normal saline. The primary endpoint is transfusion requirement (more than 1 unit of packed erythrocytes) for postoperative care until discharge and secondary endpoint are major complications, such as delayed ventilator therapy, acute kidney injury, and mortality. Reticulocyte count, plasma hepcidin, iron profiles (serum iron, serum ferritin, total iron-binding capacity, transferrin, transferrin saturation), coagulation profiles, urinary analysis, and chemical profiles are measured for three preoperative baseline-data days and just before surgery, except for hepcidin. After surgery, daily routine basic laboratory tests are measured just before discharge and reticulocyte count, iron profiles, and hepcidin are repeatedly checked for three postoperative days. Discussions: From our study, we can clarify the following points: the first is the perioperative IVFe effect on the demand for transfusion, and clinical outcomes in reoperation or complex valve surgery and the second is the role of hepcidin in the effect of IVFe on the hemoglobin level increase.

Original languageEnglish
Article number350
JournalTrials
Volume19
Issue number1
DOIs
Publication statusPublished - 2018 Jul 4

Fingerprint

Hepcidins
Thoracic Surgery
Randomized Controlled Trials
Iron
Reoperation
Reticulocyte Count
Transferrin
Control Groups
Postoperative Care
Heart Valves
Mechanical Ventilators
Ferritins
Serum
Acute Kidney Injury
Coronary Artery Bypass
iron isomaltoside 1000
Anemia
Hemoglobins
Erythrocytes
Mortality

All Science Journal Classification (ASJC) codes

  • Medicine (miscellaneous)
  • Pharmacology (medical)

Cite this

@article{bb01e24f0cd74a8fa6cd88eb14a07fb0,
title = "The effect of perioperative intravenously administered iron isomaltoside 1000 (Monofer{\circledR}) on transfusion requirements for patients undergoing complex valvular heart surgery: Study protocol for a randomized controlled trial",
abstract = "Background: Anemia is a frequent complication after cardiac surgery especially following reoperation due to previous prosthetic valve failure or multiple valve surgery (including combined coronary artery bypass grafting). This trial explores whether intravenously administered iron isomaltoside 1000 (Monofer{\circledR}) results in better clinical outcomes in patients undergoing complex heart valve surgery who are expected to receive transfusion. Methods/design: In this prospective, single-center, double-blinded, randomized controlled trial, 214 patients undergoing reoperation or multiple valve surgery are randomly allocated to either the iron isomaltoside 1000 (IVFe) or the control group from August 2016 to August 2018. The IVFe group receives iron isomaltoside 1000 mg (maximum dose 20 mg/kg) intravenously 3 days before and after the surgery. The control group receives an equivalent volume of normal saline. The primary endpoint is transfusion requirement (more than 1 unit of packed erythrocytes) for postoperative care until discharge and secondary endpoint are major complications, such as delayed ventilator therapy, acute kidney injury, and mortality. Reticulocyte count, plasma hepcidin, iron profiles (serum iron, serum ferritin, total iron-binding capacity, transferrin, transferrin saturation), coagulation profiles, urinary analysis, and chemical profiles are measured for three preoperative baseline-data days and just before surgery, except for hepcidin. After surgery, daily routine basic laboratory tests are measured just before discharge and reticulocyte count, iron profiles, and hepcidin are repeatedly checked for three postoperative days. Discussions: From our study, we can clarify the following points: the first is the perioperative IVFe effect on the demand for transfusion, and clinical outcomes in reoperation or complex valve surgery and the second is the role of hepcidin in the effect of IVFe on the hemoglobin level increase.",
author = "Lee, {Seung Hyun} and Shim, {Jae Kwang} and Sarah Soh and Song, {Jong Wook} and Chang, {Byung Chul} and Sak Lee and Kwak, {Young Lan}",
year = "2018",
month = "7",
day = "4",
doi = "10.1186/s13063-018-2545-3",
language = "English",
volume = "19",
journal = "Trials",
issn = "1745-6215",
publisher = "BioMed Central",
number = "1",

}

The effect of perioperative intravenously administered iron isomaltoside 1000 (Monofer®) on transfusion requirements for patients undergoing complex valvular heart surgery : Study protocol for a randomized controlled trial. / Lee, Seung Hyun; Shim, Jae Kwang; Soh, Sarah; Song, Jong Wook; Chang, Byung Chul; Lee, Sak; Kwak, Young Lan.

In: Trials, Vol. 19, No. 1, 350, 04.07.2018.

Research output: Contribution to journalArticle

TY - JOUR

T1 - The effect of perioperative intravenously administered iron isomaltoside 1000 (Monofer®) on transfusion requirements for patients undergoing complex valvular heart surgery

T2 - Study protocol for a randomized controlled trial

AU - Lee, Seung Hyun

AU - Shim, Jae Kwang

AU - Soh, Sarah

AU - Song, Jong Wook

AU - Chang, Byung Chul

AU - Lee, Sak

AU - Kwak, Young Lan

PY - 2018/7/4

Y1 - 2018/7/4

N2 - Background: Anemia is a frequent complication after cardiac surgery especially following reoperation due to previous prosthetic valve failure or multiple valve surgery (including combined coronary artery bypass grafting). This trial explores whether intravenously administered iron isomaltoside 1000 (Monofer®) results in better clinical outcomes in patients undergoing complex heart valve surgery who are expected to receive transfusion. Methods/design: In this prospective, single-center, double-blinded, randomized controlled trial, 214 patients undergoing reoperation or multiple valve surgery are randomly allocated to either the iron isomaltoside 1000 (IVFe) or the control group from August 2016 to August 2018. The IVFe group receives iron isomaltoside 1000 mg (maximum dose 20 mg/kg) intravenously 3 days before and after the surgery. The control group receives an equivalent volume of normal saline. The primary endpoint is transfusion requirement (more than 1 unit of packed erythrocytes) for postoperative care until discharge and secondary endpoint are major complications, such as delayed ventilator therapy, acute kidney injury, and mortality. Reticulocyte count, plasma hepcidin, iron profiles (serum iron, serum ferritin, total iron-binding capacity, transferrin, transferrin saturation), coagulation profiles, urinary analysis, and chemical profiles are measured for three preoperative baseline-data days and just before surgery, except for hepcidin. After surgery, daily routine basic laboratory tests are measured just before discharge and reticulocyte count, iron profiles, and hepcidin are repeatedly checked for three postoperative days. Discussions: From our study, we can clarify the following points: the first is the perioperative IVFe effect on the demand for transfusion, and clinical outcomes in reoperation or complex valve surgery and the second is the role of hepcidin in the effect of IVFe on the hemoglobin level increase.

AB - Background: Anemia is a frequent complication after cardiac surgery especially following reoperation due to previous prosthetic valve failure or multiple valve surgery (including combined coronary artery bypass grafting). This trial explores whether intravenously administered iron isomaltoside 1000 (Monofer®) results in better clinical outcomes in patients undergoing complex heart valve surgery who are expected to receive transfusion. Methods/design: In this prospective, single-center, double-blinded, randomized controlled trial, 214 patients undergoing reoperation or multiple valve surgery are randomly allocated to either the iron isomaltoside 1000 (IVFe) or the control group from August 2016 to August 2018. The IVFe group receives iron isomaltoside 1000 mg (maximum dose 20 mg/kg) intravenously 3 days before and after the surgery. The control group receives an equivalent volume of normal saline. The primary endpoint is transfusion requirement (more than 1 unit of packed erythrocytes) for postoperative care until discharge and secondary endpoint are major complications, such as delayed ventilator therapy, acute kidney injury, and mortality. Reticulocyte count, plasma hepcidin, iron profiles (serum iron, serum ferritin, total iron-binding capacity, transferrin, transferrin saturation), coagulation profiles, urinary analysis, and chemical profiles are measured for three preoperative baseline-data days and just before surgery, except for hepcidin. After surgery, daily routine basic laboratory tests are measured just before discharge and reticulocyte count, iron profiles, and hepcidin are repeatedly checked for three postoperative days. Discussions: From our study, we can clarify the following points: the first is the perioperative IVFe effect on the demand for transfusion, and clinical outcomes in reoperation or complex valve surgery and the second is the role of hepcidin in the effect of IVFe on the hemoglobin level increase.

UR - http://www.scopus.com/inward/record.url?scp=85049521188&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85049521188&partnerID=8YFLogxK

U2 - 10.1186/s13063-018-2545-3

DO - 10.1186/s13063-018-2545-3

M3 - Article

C2 - 29973224

AN - SCOPUS:85049521188

VL - 19

JO - Trials

JF - Trials

SN - 1745-6215

IS - 1

M1 - 350

ER -