Clinical trial NCT03470649: Effect of IV Iron Isomaltoside on Postoperative Anemia in Total Knee Arthroplasty Patients
Official title: Effect of Intravenous Iron Isomaltoside on Postoperative Anemia in Patients Underwent Total Knee Arthroplasty: A Single-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Knee Arthropathy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-03-20
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Postoperative anemia
timeFrame: 30 days after surgery
Secondary outcomes:
measure: Transfusion
timeFrame: During admission period for surgery, an average of 2 weeks
measure: Hemoglobin
timeFrame: 1 day, 7 days, and 30 days after surgery
measure: Hematocrit
timeFrame: 1 day, 7 days, and 30 days after surgery
measure: Iron
timeFrame: 1 day, 7 days, and 30 days after surgery
measure: Ferritin
timeFrame: 1 day, 7 days, and 30 days after surgery
measure: Transferrin saturation
timeFrame: 1 day, 7 days, and 30 days after surgery
measure: Phosphorus
timeFrame: 1 day, 7 days, and 30 days after surgery
measure: Surgical site infection
timeFrame: During admission period for surgery, an average of 2 weeks
measure: Hospital length of stay
timeFrame: During admission period for surgery, an average of 2 weeks
measure: Quality of life using EQ-5D
timeFrame: 30 days after surgery
measure: Quality of life using FACT-An
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jin-Tae Kim, Pf.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.