Effect of Postoperative Ferric Carboxymaltose

Status Not yet recruiting

Clinical Trial Summary

The primary purpose of this study is to evaluate the safety and efficacy of postoperative intravenous ferric carboxymaltose in patients with anemia undergoing Simultaneous Bilateral Total knee replacement in terms of Quality of life (QOL) and objective measures (Hemoglobin and Iron parameters).

Clinical Trial 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(hemoglobin) level of 10 g/dl will be used as a cut-off value for our study. In postoperative period in total knee arthroplasty for osteoarthritis, consented patients with postoperative 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 normal as infusion or 10mL(milliliter) as bolus injection) for body weight <50 Kg (kilogram). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03561480
Study type	Interventional
Source	The Catholic University of Korea
Contact	Yong In, MD, PhD
Phone	8290445228
Email	iy1000@catholic.ac.kr
Status	Not yet recruiting
Phase	Phase 4
Start date	June 11, 2018
Completion date	December 11, 2019

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04651673` - Prescribed Knee Brace Treatments for Osteoarthritis of the Knee (Knee OA)
Completed	`NCT05677399` - Knee Osteoarthritis Treatment With Peloidotherapy and Aquatic Exercise.	N/A
Active, not recruiting	`NCT04043819` - Evaluation of Safety and Exploratory Efficacy of an Autologous Adipose-derived Cell Therapy Product for Treatment of Single Knee Osteoarthritis	Phase 1
Recruiting	`NCT06000410` - A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee	Phase 3
Completed	`NCT05014542` - Needling Techniques for Knee Osteoarthritis	N/A
Recruiting	`NCT05892133` - Prehabilitation Effect on Function and Patient Satisfaction Following Total Knee Arthroplasty	N/A
Recruiting	`NCT05528965` - Parallel Versus Perpendicular Technique for Genicular Radiofrequency	N/A
Active, not recruiting	`NCT03472300` - Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
Active, not recruiting	`NCT02003976` - A Randomized Trial Comparing High Tibial Osteotomy Plus Non-Surgical Treatment and Non-Surgical Treatment Alone	N/A
Active, not recruiting	`NCT04017533` - Stability of Uncemented Medially Stabilized TKA	N/A
Completed	`NCT04779164` - The Relation Between Abdominal Obesity, Type 2 Diabetes Mellitus and Knee Osteoarthritis	N/A
Recruiting	`NCT04006314` - Platelet Rich Plasma and Neural Prolotherapy Injections in Treating Knee Osteoarthritis	N/A
Recruiting	`NCT05423587` - Genicular Artery Embolisation for Knee Osteoarthritis II	N/A
Enrolling by invitation	`NCT04145401` - Post Market Clinical Follow-Up Study- EVOLUTION® Revision CCK
Active, not recruiting	`NCT03781843` - Effects of Genicular Nerve Block in Knee Osteoarthritis	N/A
Recruiting	`NCT05974501` - Pre vs Post Block in Total Knee Arthroplasty (TKA)	Phase 4
Completed	`NCT05324163` - Evaluate Efficacy and Safety of X0002 in Treatment of Knee Osteoarthritis	Phase 3
Completed	`NCT05529914` - Effects of Myofascial Release and Neuromuscular Training for Pes Anserine Syndrome Associated With Knee Osteoarthritis	N/A
Recruiting	`NCT05693493` - Can Proprioceptive Knee Brace Improve Functional Outcome Following TKA?	N/A
Not yet recruiting	`NCT05510648` - Evaluation of the Effect of High-intensity Laser Therapy in Knee Osteoarthritis	N/A