Intravenous Iron Pre-treatment in Prognathic Surgery

NCT ID: NCT02800746

Last Updated: 2018-03-20

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

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-30

Study Completion Date

2018-12-31

Brief Summary

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The objective of the present study is to determine the impact of preoperative IV-iron (ferric carboxy maltose) supplementation on postoperative hematocrit values and allogenic blood transfusion amount in patients undergoing elective prognathic surgery.

Detailed Description

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Conditions

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Prognathic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Experimental group

Ferric carboxymaltose

Group Type EXPERIMENTAL

Ferric carboxymaltose

Intervention Type DRUG

Ferric carboxymaltose 15 mg/kg mg is intravenously administered on 7-10 day before surgery.

Control Group

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

normal saline 100 ml is intravenously administered on 7-10 day before surgery

Interventions

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Ferric carboxymaltose

Ferric carboxymaltose 15 mg/kg mg is intravenously administered on 7-10 day before surgery.

Intervention Type DRUG

Placebo

normal saline 100 ml is intravenously administered on 7-10 day before surgery

Intervention Type DRUG

Other Intervention Names

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normal saline

Eligibility Criteria

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Inclusion Criteria

* Patients with prognathism in undergoing elective prognathic surgery
* Patients provided a written informed consent.
* Patients with s-ferritin \< 300 mg/dl (male) or 200 mg/dl (female)
* Patients with preoperative Hematocrit \> 39% (male) and \> 36% 9female)serum hemoglobin \>13 g/dL (male) and \>12 g/dL (female)

Exclusion Criteria

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

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Tae-Yop Kim, MD, PhD

Role: CONTACT

82-2-2030-5445

Other Identifiers

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KUH1160000

Identifier Type: -

Identifier Source: org_study_id

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