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Trial record 21 of 380 for:    FERRIC CATION

Effect of Preoperative Ferric Carboxymaltose After Simultaneous Bilateral Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT03561506
Recruitment Status : Not yet recruiting
First Posted : June 19, 2018
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Yong In, The Catholic University of Korea

Brief Summary:
The primary purpose of this study is to evaluate the safety and efficacy of preoperative intravenous ferric carboxymaltose in patients with anemia undergoing Simultaneous Bilateral Total knee replacement in terms of Quality of life (QOL) and objective measures (Hb and Iron parameters).

Condition or disease Intervention/treatment Phase
Postoperative Anemia Knee Osteoarthritis Total Knee Arthroplasty Drug: Ferric carboxymaltose Drug: 0.9% Normal Saline Phase 4

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 level of 13 g/dl in man and 12 g/dl in woman will be used as a cut-off value for our study based on the definition of anemia. 3 weeks before total knee arthroplasty for osteoarthritis, consented patients with preoperative 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(milliliter) normal as infusion or 10mL(milliliter) as bolus injection) for body weight <50 Kg(kilogram).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Preoperative Ferric Carboxymaltose After Simultaneous Bilateral Total Knee Arthroplasty : A Randomized, Controlled, Double-Blind Trial
Estimated Study Start Date : June 11, 2018
Estimated Primary Completion Date : June 11, 2019
Estimated Study Completion Date : December 11, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ferric carboxymaltose group
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 .
Drug: Ferric carboxymaltose
Ferinject®to be administered as IV drip infusion or undiluted bolus injection to consented patients with preoperative anemia before total knee arthroplasty.
Other Name: Ferinject®

Active Comparator: Placebo group
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.
Drug: 0.9% Normal Saline
Placebo(0.9% Normal Saline) to be administered as IV drip infusion or bolus injection to consented patients with preoperative anemia before total knee arthroplasty.




Primary Outcome Measures :
  1. Hb increase from baseline till day of surgery [ Time Frame: Postoperative 8 weeks from baseline ]
    Hb increase from baseline till day of surgery


Secondary Outcome Measures :
  1. Percentage of patients requiring alternative anaemia management therapy [ Time Frame: Percentage of patients requiring alternative anaemia management therapy up to 8weeks ]
    Percentage of patients requiring alternative anaemia management therapy

  2. WOMAC(Western Ontario and McMaster University Arthritis Index ) scale [ Time Frame: baseline and postoperative 2, 4, 8 weeks ]
    WOMAC(Western Ontario and McMaster University Arthritis Index ) scale

  3. Brief pain inventory [ Time Frame: baseline and postoperative 2, 4, 8 weeks ]
    Brief pain inventory

  4. Self-reported patient assessment of EQ-5D (EuroQol-5 dimension ) [ Time Frame: baseline and postoperative 4, 8 weeks ]
    Self-reported patient assessment of EQ-5D (EuroQol-5 dimension )



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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:

  • > 18 years of age and signed written informed consent
  • Patients scheduled to undergo major orthopaedic surgery (hip or knee arthroplasty or back surgery)
  • Hb < 13.0 g/dl for men and Hb < 12.0 g/dl for women, at screening ( 3 weeks prior to surgery)
  • Ferritin < 100 μg/l or 100-300 with transferrin saturation < 20%

Exclusion Criteria:

  • Suspicion of iron overload (Ferritin >300 μg/l or/andtransferrin 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

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): NCT03561506


Contacts
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Contact: Yong In, MD, PhD 8290445228 iy1000@catholic.ac.kr
Contact: Man Soo Kim, MD 8272333875 kms3779@naver.com

Sponsors and Collaborators
The Catholic University of Korea
Investigators
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Study Chair: Yong In, MD, PhD The Catholic Univerisity of Korea Seoul St Mary's hospital

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Responsible Party: Yong In, Profsessor, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT03561506     History of Changes
Other Study ID Numbers: Ferric Carboxymaltose
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Ferric Compounds
Hematinics