Intraoperative IV Iron on Postoperative Red Blood Cell Recovery

NCT ID: NCT04035902

Last Updated: 2020-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-31

Study Completion Date

2021-12-31

Brief Summary

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The objective of the present study is to determine the impact of intraoperative IV-iron supplementation on postoperative recovery of RBC mass by retrospectively analyzing and comparing the changes of postoperative hematocrit values after the surgery in patients underwent elective uni-limb total knee arthroplasty surgery with or without IV-iron supplementation during surgery

Detailed Description

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Conditions

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Osteoarthritis, Hip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ferric carboxymaltose 1000 mg

Ferric carboxymaltose is administered during surgery

Group Type EXPERIMENTAL

Ferric carboxymaltose

Intervention Type DRUG

Ferric carboxymaltose is administered during surgery

control

Ferric carboxymaltose is not administered

Group Type ACTIVE_COMPARATOR

control

Intervention Type DRUG

Ferric carboxymaltose is not administered

Interventions

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Ferric carboxymaltose

Ferric carboxymaltose is administered during surgery

Intervention Type DRUG

control

Ferric carboxymaltose is not administered

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with osteoarthritis in knee joint undergoing elective uni-limb total knee arthroplasty surgery
* Patients provided a written informed consent.
* Patients with s-ferritin \< 300 mg/dl (male) or 200 mg/dl (female)
* Patients with preoperative serum hemoglobin concentration \>10 g/dL

Exclusion Criteria

* Patients with history of anaphylaxis, iron overload, active infection.
* Patients received or receiving intraoperative and preoperative blood salvaged, allogenic blood transfusion, recombinant human erythropoietin, or undergoing acute normovolemic hemodilution.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Konkuk University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Tae-Yop Kim, MD PhD

Professor Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Tae-Yop Kim, MD PhD

Role: CONTACT

0220305445

Other Identifiers

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KUH 2019-05-008

Identifier Type: -

Identifier Source: org_study_id

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