Effect of IV Iron Isomaltoside on Postoperative Anemia in Total Knee Arthroplasty Patients

Effect of Intravenous Iron Isomaltoside on Postoperative Anemia in Patients Underwent Total Knee Arthroplasty: A Single-blind Randomized Controlled Trial

Postoperative anemia is a frequent complication after total knee arthroplasty, with an incidence of 87%. Iron supplementation is known to be effective in treatment and prevention of postoperative anemia. The investigators examined the effect of intravenous iron isomaltoside (Monofer®) administration on postoperative anemia and transfusion requirements in patients undergoing total knee arthroplasty.

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.

Study Overview

• Status: Completed
• Conditions: Anemia; Knee Arthropathy
• Intervention / Treatment: Drug: Iron Isomaltoside 1000

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patients undergoing total knee arthroplasty

Exclusion Criteria:

• bilateral total knee arthroplasty
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Iron Isomaltoside 1000; Iron Isomaltoside 1000 would be intravenously administrated to treatment group after main procedure of total knee arthroplasty.; Other Names: treatment
No Intervention: Control; Patients in this group would receive 100ml of normal saline after main procedure of total knee arthroplasty.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative anemia	Incidence of postoperative anemia at 30 days after surgery	30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transfusion	Incidence and amount of red blood cell transfusion during admission	During admission period for surgery, an average of 2 weeks
Hemoglobin	serum hemoglobin level (g/dL)	1 day, 7 days, and 30 days after surgery
Hematocrit	Hematocrit level (%)	1 day, 7 days, and 30 days after surgery
Iron	serum iron level (μg/dL)	1 day, 7 days, and 30 days after surgery
Ferritin	serum ferritin level (ng/mL)	1 day, 7 days, and 30 days after surgery
Transferrin saturation	Transferrin saturation (%)	1 day, 7 days, and 30 days after surgery
Phosphorus	Serum phosphorus level (mg/dL)	1 day, 7 days, and 30 days after surgery
Surgical site infection	Incidence of surgical site infection	During admission period for surgery, an average of 2 weeks
Hospital length of stay	Hospital length of stay (days)	During admission period for surgery, an average of 2 weeks
Quality of life using EQ-5D	Assessment of quality of life during postoperative periods using EQ-5D (EuroQol-5 Dimension) questionaire	30 days after surgery
Quality of life using FACT-An	Assessment of quality of life during postoperative periods using FACT-An (The Functional Assessment of Cancer Therapy-Anemia) questionaire	30 days after surgery

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2018
• Primary Completion (Actual): April 16, 2019
• Study Completion (Actual): April 17, 2019

Study Registration Dates

• First Submitted: March 13, 2018
• First Submitted That Met QC Criteria: March 18, 2018
• First Posted (Actual): March 20, 2018

Study Record Updates

• Last Update Posted (Actual): April 18, 2019
• Last Update Submitted That Met QC Criteria: April 16, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia; Hematinics; Iron isomaltoside 1000
• Other Study ID Numbers: H-1709-079-885

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No