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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03561506
Other study ID # Ferric Carboxymaltose
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date June 11, 2018
Est. completion date December 11, 2019

Study information

Verified date June 2018
Source The Catholic University of Korea
Contact Yong In, MD, PhD
Phone 8290445228
Email iy1000@catholic.ac.kr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Description:

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Study Design


Intervention

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.
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
The Catholic University of Korea

Outcome

Type Measure Description Time frame Safety issue
Primary Hb increase from baseline till day of surgery Hb increase from baseline till day of surgery Postoperative 8 weeks from baseline
Secondary 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
Secondary 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
Secondary Brief pain inventory Brief pain inventory baseline and postoperative 2, 4, 8 weeks
Secondary 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
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