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

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ClinicalTrials.gov Identifier: NCT03470649
Recruitment Status : Completed
First Posted : March 20, 2018
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Jin-Tae Kim, Seoul National University Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Anemia Knee Arthropathy Drug: Iron Isomaltoside 1000 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Intravenous Iron Isomaltoside on Postoperative Anemia in Patients Underwent Total Knee Arthroplasty: A Single-blind Randomized Controlled Trial
Actual Study Start Date : March 29, 2018
Actual Primary Completion Date : April 16, 2019
Actual Study Completion Date : April 17, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: treatment
No Intervention: Control
Patients in this group would receive 100ml of normal saline after main procedure of total knee arthroplasty.


Outcome Measures
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Primary Outcome Measures :
  1. Postoperative anemia [ Time Frame: 30 days after surgery ]
    Incidence of postoperative anemia at 30 days after surgery


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03470649


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Jin-Tae Kim, Pf. Seoul National University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jin-Tae Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03470649    
Other Study ID Numbers: H-1709-079-885
First Posted: March 20, 2018    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019

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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
Additional relevant MeSH terms:
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Anemia
Hematologic Diseases
Iron isomaltoside 1000
Hematinics