Effect of Preoperative Ferric Carboxymaltose After Simultaneous Bilateral Total Knee Arthroplasty

Phase 4

• Conditions: Postoperative Anemia; Knee Osteoarthritis; Total Knee Arthroplasty
• Interventions: Drug: 0.9% Normal Saline; Drug: Ferric carboxymaltose

• Registration Number: NCT03561506
• Lead Sponsor: 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).

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 Timeline

• Status Verified: 2018-06
• Study First Submitted: 2018-06-04
• Study Start: 2018-06-11
• Study First Submitted QC: 2018-06-18
• Last Update Submitted: 2018-06-18
• Study First Posted: 2018-06-19
• Last Update Posted: 2018-06-19
• Primary Completion: 2019-06-11
• Study Completion: 2019-12-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	0.9% Normal Saline	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.
Ferric carboxymaltose group	Ferric carboxymaltose	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 .

Primary Outcome Measures

Name	Time	Method
Hb increase from baseline till day of surgery	Postoperative 8 weeks from baseline	Hb increase from baseline till day of surgery

Secondary Outcome Measures

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