Effect of IV Iron Isomaltoside on Postoperative Anemia in Total Knee Arthroplasty Patients
NCT ID: NCT03470649
Last Updated: 2019-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2018-03-29
2019-04-17
Brief Summary
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Participants undergoing total knee arthroplasty will be randomly assigned to treatment group or control group. After main procedure of total knee arthroplasty, iron isomaltoside 1000 (Monofer®) or normal saline will be intravenously administered depending on the group assigned. The dose of iron isomaltoside will be determined based on patient's body weight using the manufacturer's recommendation. Serum hemoglobin, hematocrit, iron, ferritin, transferrin saturation, and phosphorus level will be checked at preoperative day, postoperative day 1, 7, and 30.
The primary outcome is the incidence of postoperative anemia at 30 days after surgery. Secondary outcomes included the incidence and amount of red blood cell transfusion during admission period, hospital length of stay, the incidence of surgical site infection, and quality of life during postoperative period.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Treatment
Patients in this group would receive Iron Isomaltoside 1000 (Monofer®) after main procedure of total knee arthroplasty. The dose of iron isomaltoside would be determined based on the patient's body weight.
Iron Isomaltoside 1000
Iron Isomaltoside 1000 would be intravenously administrated to treatment group after main procedure of total knee arthroplasty.
Control
Patients in this group would receive 100ml of normal saline after main procedure of total knee arthroplasty.
No interventions assigned to this group
Interventions
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Iron Isomaltoside 1000
Iron Isomaltoside 1000 would be intravenously administrated to treatment group after main procedure of total knee arthroplasty.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* hematochromatosis or hemosiderosis
* hemolytic anemia
* history of drug allergy
* liver cirrhosis or hepatitis
* systematic lupus erythematosus
* rheumatic arthritis
* allergic disease
* history of transfusion within one month from surgery
* parturient
19 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Jin-Tae Kim
Professor
Principal Investigators
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Jin-Tae Kim, Pf.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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References
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Yoo S, Bae J, Ro DH, Han HS, Lee MC, Park SK, Lim YJ, Bahk JH, Kim JT. Efficacy of intra-operative administration of iron isomaltoside for preventing postoperative anaemia after total knee arthroplasty: A randomised controlled trial. Eur J Anaesthesiol. 2021 Apr 1;38(4):358-365. doi: 10.1097/EJA.0000000000001389.
Other Identifiers
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H-1709-079-885
Identifier Type: -
Identifier Source: org_study_id
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