Clinical trial NCT03561506: Effect of Preoperative Ferric Carboxymaltose After Simultaneous Bilateral Total Knee Arthroplasty
Official title: Effect of Preoperative Ferric Carboxymaltose After Simultaneous Bilateral Total Knee Arthroplasty : A Randomized, Controlled, Double-Blind Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postoperative Anemia
Knee Osteoarthritis
Total Knee Arthroplasty
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2018-06-19
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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 \< 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

Primary outcomes:
measure: Hb increase from baseline till day of surgery
timeFrame: Postoperative 8 weeks from baseline
Secondary outcomes:
measure: Percentage of patients requiring alternative anaemia management therapy
timeFrame: Percentage of patients requiring alternative anaemia management therapy up to 8weeks
measure: WOMAC(Western Ontario and McMaster University Arthritis Index ) scale
timeFrame: baseline and postoperative 2, 4, 8 weeks
measure: Brief pain inventory
timeFrame: baseline and postoperative 2, 4, 8 weeks
measure: Self-reported patient assessment of EQ-5D (EuroQol-5 dimension )
timeFrame: baseline and postoperative 4, 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: The Catholic Univerisity of Korea Seoul St Mary's hospital
name: Yong In, MD, PhD
role: STUDY_CHAIR
References: