NCT03561506

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: The Catholic University of Korea · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Postoperative Anemia
• Knee Osteoarthritis
• Total Knee Arthroplasty

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2018-06-11
• Primary completion: 2019-06-11
• Completion: 2019-12-11
• First posted: 2018-06-19
• Last updated: 2018-06-19

Regulatory

• FDA-regulated drug study