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Completed

NCT Number: NCT03470649

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

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Iron Isomaltoside 1000

Drug

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

Other names: treatment

Primary outcomes

  1. Postoperative anemia

    Time frame: 30 days after surgery

    Incidence of postoperative anemia at 30 days after surgery

Secondary outcomes

  1. Transfusion

    Time frame: During admission period for surgery, an average of 2 weeks

    Incidence and amount of red blood cell transfusion during admission

  2. Hemoglobin

    Time frame: 1 day, 7 days, and 30 days after surgery

    serum hemoglobin level (g/dL)

  3. Hematocrit

    Time frame: 1 day, 7 days, and 30 days after surgery

    Hematocrit level (%)

  4. Iron

    Time frame: 1 day, 7 days, and 30 days after surgery

    serum iron level (μg/dL)

  5. Ferritin

    Time frame: 1 day, 7 days, and 30 days after surgery

    serum ferritin level (ng/mL)

  6. Transferrin saturation

    Time frame: 1 day, 7 days, and 30 days after surgery

    Transferrin saturation (%)

  7. Phosphorus

    Time frame: 1 day, 7 days, and 30 days after surgery

    Serum phosphorus level (mg/dL)

  8. Surgical site infection

    Time frame: During admission period for surgery, an average of 2 weeks

    Incidence of surgical site infection

  9. Hospital length of stay

    Time frame: During admission period for surgery, an average of 2 weeks

    Hospital length of stay (days)

  10. Quality of life using EQ-5D

    Time frame: 30 days after surgery

    Assessment of quality of life during postoperative periods using EQ-5D (EuroQol-5 Dimension) questionaire

  11. Quality of life using FACT-An

    Time frame: 30 days after surgery

    Assessment of quality of life during postoperative periods using FACT-An (The Functional Assessment of Cancer Therapy-Anemia) questionaire

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 20, 2018
Registry last updated
Apr 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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