Effect of Preoperative Ferric Carboxymaltose After Simultaneous Bilateral Total Knee Arthroplasty

Effect of Preoperative Ferric Carboxymaltose After Simultaneous Bilateral Total Knee Arthroplasty : A Randomized, Controlled, Double-Blind Trial

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).

Study Overview

• Status: Unknown
• Conditions: Knee Osteoarthritis; Total Knee Arthroplasty; Postoperative Anemia
• Intervention / Treatment: Drug: Ferric carboxymaltose; Drug: 0.9% Normal Saline

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).

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hb increase from baseline till day of surgery	Hb increase from baseline till day of surgery	Postoperative 8 weeks from baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients requiring alternative anaemia management therapy	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	WOMAC(Western Ontario and McMaster University Arthritis Index ) scale	baseline and postoperative 2, 4, 8 weeks
Brief pain inventory	Brief pain inventory	baseline and postoperative 2, 4, 8 weeks
Self-reported patient assessment of EQ-5D (EuroQol-5 dimension )	Self-reported patient assessment of EQ-5D (EuroQol-5 dimension )	baseline and postoperative 4, 8 weeks

Collaborators and Investigators

• Sponsor: The Catholic University of Korea

Study record dates

Study Major Dates

• Study Start (Anticipated): June 11, 2018
• Primary Completion (Anticipated): June 11, 2019
• Study Completion (Anticipated): December 11, 2019

Study Registration Dates

• First Submitted: June 4, 2018
• First Submitted That Met QC Criteria: June 18, 2018
• First Posted (Actual): June 19, 2018

Study Record Updates

• Last Update Posted (Actual): June 19, 2018
• Last Update Submitted That Met QC Criteria: June 18, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: Ferric Carboxymaltose

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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