Effect of Preoperative Ferric Carboxymaltose After Simultaneous Bilateral Total Knee Arthroplasty

NCT03561506 | Unknown Phase 4 FDA Drug

• 1 other identifier: Ferric Carboxymaltose
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Postoperative Anemia; Knee Osteoarthritis; Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Hb increase from baseline till day of surgery

  Hb increase from baseline till day of surgery

  Postoperative 8 weeks from baseline

Secondary Outcomes (4)

• Percentage of patients requiring alternative anaemia management therapy

  Percentage of patients requiring alternative anaemia management therapy up to 8weeks

• WOMAC(Western Ontario and McMaster University Arthritis Index ) scale

  baseline and postoperative 2, 4, 8 weeks

• Brief pain inventory

  baseline and postoperative 2, 4, 8 weeks

• Self-reported patient assessment of EQ-5D (EuroQol-5 dimension )

  baseline and postoperative 4, 8 weeks

Study Arms (2)

Ferric carboxymaltose group

EXPERIMENTAL

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

Placebo group

ACTIVE COMPARATOR

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

Interventions

Ferric carboxymaltose DRUG

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

Also known as: Ferinject®

Ferric carboxymaltose group

0.9% Normal Saline DRUG

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.

Placebo group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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%

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• The Catholic University of Korea: lead

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

ferric carboxymaltose; Saline Solution

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Yong In, MD, PhD

  The Catholic Univerisity of Korea Seoul St Mary's hospital

  STUDY CHAIR

Central Study Contacts

Yong In, MD, PhD

CONTACT

8290445228; iy1000@catholic.ac.kr

Man Soo Kim, MD

CONTACT

8272333875; kms3779@naver.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profsessor

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: June 19, 2018
• Study Start: June 11, 2018
• Primary Completion: June 11, 2019
• Study Completion: December 11, 2019
• Last Updated: June 19, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share