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

NCT03470649 | Completed

• 1 other identifier: H-1709-079-885
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anemia; Knee Arthropathy

Outcome Measures

Primary Outcomes (1)

• Postoperative anemia

  Incidence of postoperative anemia at 30 days after surgery

  30 days after surgery

Secondary Outcomes (11)

• Transfusion

  During admission period for surgery, an average of 2 weeks

• Hemoglobin

  1 day, 7 days, and 30 days after surgery

• Hematocrit

  1 day, 7 days, and 30 days after surgery

• Iron

  1 day, 7 days, and 30 days after surgery

• Ferritin

  1 day, 7 days, and 30 days after surgery

Study Arms (2)

Treatment

EXPERIMENTAL

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

Control

NO INTERVENTION

Patients in this group would receive 100ml of normal saline after main procedure of total knee arthroplasty.

Interventions

Iron Isomaltoside 1000 DRUG

Iron Isomaltoside 1000 would be intravenously administrated to treatment group after main procedure of total knee arthroplasty.

Also known as: treatment

Treatment

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients undergoing total knee arthroplasty

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (1)

• 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.

  PMID: 33259451 DERIVED

MeSH Terms

Conditions

Anemia

Interventions

iron isomaltoside 1000; Therapeutics

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Jin-Tae Kim, Pf.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: March 20, 2018
• Study Start: March 29, 2018
• Primary Completion: April 16, 2019
• Study Completion: April 17, 2019
• Last Updated: April 18, 2019

Record last verified: 2019-04

Locations

KR (1)