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Effect of Preoperative Ferric Carboxymaltose After Simultaneous Bilateral Total Knee Arthroplasty

NCT03561506 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2018-06-19

No results posted yet for this study

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).

Conditions

Interventions

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.

Sponsors & Collaborators

  • The Catholic University of Korea

    lead OTHER

Principal Investigators

  • Yong In, MD, PhD · The Catholic Univerisity of Korea Seoul St Mary's hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-11
Primary Completion
2019-06-11
Completion
2019-12-11
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03561506 on ClinicalTrials.gov