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Effect of Postoperative Ferric Carboxymaltose

Primary Purpose

Postoperative Anemia, Knee Osteoarthritis, Total Knee Arthroplasty

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ferric carboxymaltose
0.9% Normal Saline
Sponsored by
The Catholic University of Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Anemia

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • > 18 years of age and signed written informed consent
  • Patients scheduled to undergo major orthopaedic surgery (hip or knee arthroplasty or back surgery)
  • Hb < 10.0 g/dl after operation
  • Ferritin < 100 μg/l or 100-300 with transferrin saturation < 20%

Exclusion Criteria:

  • Suspicion of iron overload (Ferritin >300 μg/l or/and transferrin saturation>50%)
  • Active severe infection/inflammation (defined as serum C reactive protein > 20 mg/l) or diagnosed malignancy
  • Folate-and/or Vitamin B12 deficiency (according to local lab reference range)
  • Known history of hepatitis B/C or HIV-positive
  • Liver values 3 times higher than normal
  • Immunosuppressive or myelosuppressive therapy
  • A concurrent medical condition(s) that, in the view of the investigator, would prevent compliance or participation or jeopardize the health of the patients.
  • Pregnancy or lactation
  • Transfusion within 1 month prior to study inclusion, erythropoietin treatment with in the last 4 weeks, any iron treatment within 4 weeks prior to the inclusion in the trail
  • Participation in any other therapeutic trial within the previous month
  • History of thromboembolic events in the family or the patient
  • Severe peripheral, coronary or carotid artery disease
  • Bodyweight < 50 kg
  • Patients not able to understand the German language

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Ferric carboxymaltose group

    Placebo group

    Arm Description

    Ferinject®to be administered as IV drip infusion or undiluted bolus injection to consented patients with postoperative anemia after total knee arthroplasty.

    Placebo(0.9% Normal Saline) to be administered as IV drip infusion or bolus injection to consented patients with postoperative anemia after total knee arthroplasty.

    Outcomes

    Primary Outcome Measures

    Hb increase from baseline till day of surgery
    Hb increase from baseline till day of surgery

    Secondary Outcome Measures

    Percentage of patients requiring alternative anaemia management therapy
    Percentage of patients requiring alternative anaemia management therapy
    Self-reported patient assessment of EQ-5D (EuroQol-5 dimension )
    Self-reported patient assessment of EQ-5D (EuroQol-5 dimension )
    WOMAC(Western Ontario and McMaster University Arthritis Index ) scale
    WOMAC(Western Ontario and McMaster University Arthritis Index ) scale
    Brief pain inventory
    Brief pain inventory

    Full Information

    First Posted
    June 4, 2018
    Last Updated
    June 18, 2018
    Sponsor
    The Catholic University of Korea
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03561480
    Brief Title
    Effect of Postoperative Ferric Carboxymaltose
    Official Title
    Effect of Postoperative Ferric Carboxymaltose After Simultaneous Bilateral Total Knee Arthroplasty : A Randomized, Controlled, Double-Blind Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 11, 2018 (Anticipated)
    Primary Completion Date
    June 11, 2019 (Anticipated)
    Study Completion Date
    December 11, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The Catholic University of Korea

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The primary purpose of this study is to evaluate the safety and efficacy of postoperative intravenous ferric carboxymaltose in patients with anemia undergoing Simultaneous Bilateral Total knee replacement in terms of Quality of life (QOL) and objective measures (Hemoglobin and Iron parameters).
    Detailed Description
    Both preoperative and postoperative anaemia are common in patients undergoing total knee arthroplasty. Allogeneic RBC (red blood cell) transfusion and anaemia are related with higher postoperative mortality and morbidity. It is important to have a strategy of patient blood management. Hb(hemoglobin) level of 10 g/dl will be used as a cut-off value for our study. In postoperative period in total knee arthroplasty for osteoarthritis, consented patients with postoperative anemia will be administered Ferinject® or placebo (normal saline) based on the results of randomization. Study Group: Ferinject® administration as IV drip infusion or undiluted bolus injection with a minimum administration time of 15minutes (for 1000mg(milligram) single administration) for body weight ≥50 Kg (kilogram) or 6 minutes (for 500mg(milligram) single administration) for body weight < 50Kg( kilogram) . Control Group: Placebo in the form of normal saline administration as same time period as equivalent Ferinject® administration. IV drip infusion or undiluted bolus injection with a minimum administration time of 15 minutes (200mL(milliliter) as infusion or 20mL(milliliter) as bolus injection) for body weight ≥50 Kg ( kilogram) or 6 minutes (100mL normal as infusion or 10mL(milliliter) as bolus injection) for body weight <50 Kg (kilogram).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Anemia, Knee Osteoarthritis, Total Knee Arthroplasty

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Ferric carboxymaltose group
    Arm Type
    Experimental
    Arm Description
    Ferinject®to be administered as IV drip infusion or undiluted bolus injection to consented patients with postoperative anemia after total knee arthroplasty.
    Arm Title
    Placebo group
    Arm Type
    Active Comparator
    Arm Description
    Placebo(0.9% Normal Saline) to be administered as IV drip infusion or bolus injection to consented patients with postoperative anemia after total knee arthroplasty.
    Intervention Type
    Drug
    Intervention Name(s)
    Ferric carboxymaltose
    Other Intervention Name(s)
    Ferinject®
    Intervention Description
    Ferinject®to be administered as IV drip infusion or undiluted bolus injection with a minimum administration time of 15minutes (for 1000mg single administration) for body weight ≥50 Kg or 6 minutes (for 500mg single administration) for body weight <50Kg .
    Intervention Type
    Drug
    Intervention Name(s)
    0.9% Normal Saline
    Intervention Description
    Placebo will be in the form of normal saline administered over same time period as equivalent Ferinject® administration. IV drip infusion or undiluted bolus injection with a minimum administration time of 15 minutes (200mL as infusion or 20mL as bolus injection) for body weight ≥50 Kg or 6 minutes (100mL normal as infusion or 10mL as bolus injection) for body weight <50 Kg.
    Primary Outcome Measure Information:
    Title
    Hb increase from baseline till day of surgery
    Description
    Hb increase from baseline till day of surgery
    Time Frame
    Postoperative 8 weeks from baseline
    Secondary Outcome Measure Information:
    Title
    Percentage of patients requiring alternative anaemia management therapy
    Description
    Percentage of patients requiring alternative anaemia management therapy
    Time Frame
    Percentage of patients requiring alternative anaemia management therapy up to 8weeks
    Title
    Self-reported patient assessment of EQ-5D (EuroQol-5 dimension )
    Description
    Self-reported patient assessment of EQ-5D (EuroQol-5 dimension )
    Time Frame
    baseline and postoperative 4, 8 weeks
    Title
    WOMAC(Western Ontario and McMaster University Arthritis Index ) scale
    Description
    WOMAC(Western Ontario and McMaster University Arthritis Index ) scale
    Time Frame
    baseline and postoperative 2, 4, 8 weeks
    Title
    Brief pain inventory
    Description
    Brief pain inventory
    Time Frame
    baseline and postoperative 2, 4, 8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: > 18 years of age and signed written informed consent Patients scheduled to undergo major orthopaedic surgery (hip or knee arthroplasty or back surgery) Hb < 10.0 g/dl after operation Ferritin < 100 μg/l or 100-300 with transferrin saturation < 20% Exclusion Criteria: Suspicion of iron overload (Ferritin >300 μg/l or/and transferrin saturation>50%) Active severe infection/inflammation (defined as serum C reactive protein > 20 mg/l) or diagnosed malignancy Folate-and/or Vitamin B12 deficiency (according to local lab reference range) Known history of hepatitis B/C or HIV-positive Liver values 3 times higher than normal Immunosuppressive or myelosuppressive therapy A concurrent medical condition(s) that, in the view of the investigator, would prevent compliance or participation or jeopardize the health of the patients. Pregnancy or lactation Transfusion within 1 month prior to study inclusion, erythropoietin treatment with in the last 4 weeks, any iron treatment within 4 weeks prior to the inclusion in the trail Participation in any other therapeutic trial within the previous month History of thromboembolic events in the family or the patient Severe peripheral, coronary or carotid artery disease Bodyweight < 50 kg Patients not able to understand the German language
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yong In, MD, PhD
    Phone
    8290445228
    Email
    iy1000@catholic.ac.kr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Man Soo Kim, MD
    Phone
    8272333875
    Email
    kms3779@naver.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yong In, MD, PhD
    Organizational Affiliation
    The Catholic Univerisity of Korea Seoul St Mary's hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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