NCT02800746

Unknown

Intravenous Iron Pre-treatment in Prognathic Surgery

Konkuk University Medical Center Source

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Other study identifiers

Sponsor study identifier

KUH1160000

Study Type

interventional

Estimated enrollment

48

Locations

0 countries

Sites

N/A

Timeline

Study Start

June 2018

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

December 2018

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

December 2018

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Brief Summary

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Estimated enrollment: 48 participants
Study completion date: December 2018
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
June 11, 2016
Actual (reported)
First Posted
June 15, 2016
Actual (reported)
Study Start
June 2018
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 2018
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2018
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: March 20, 2018
Status Verified: March 2018
Last Update Submitted: March 19, 2018

Conditions

Prognathic Surgery

Keywords

Prognathic surgeryintravenous iron

Outcome Measures

Primary Outcomes (1)

Serum-Hematocrit
intergroup-difference immediately after surgery, %
Postoperative 2 hour

Secondary Outcomes (3)

Serum-Ferritin level
Postoperative 2 hour
Changes of serum-Ferritin level
Postoperative 2 hour
Transfusion amount
Postoperative 2 hour

Study Arms (2)

Experimental group

EXPERIMENTAL

Ferric carboxymaltose

Drug: Ferric carboxymaltose

Control Group

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Ferric carboxymaltoseDrug

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

Experimental group

PlaceboDrug

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

Also known as: normal saline

Control Group

Eligibility Criteria

Age19 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients with prognathism in undergoing elective prognathic surgery
Patients provided a written informed consent.

Sponsors & Collaborators

Konkuk University Medical Center
Otherlead

MeSH Terms

Interventions

ferric carboxymaltoseSaline Solution

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Central Study Contacts

Tae-Yop Kim, MD, PhD

CONTACT

82-2-2030-5445 taeyop@gmail.com

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor

Study Record Dates

First Submitted

June 11, 2016

First Posted

June 15, 2016

Study Start

June 2018

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

NCT02939794

The Effect of Ferric Carboxymaltose on Hemoglobin and Blood Transfusion in Cardiac Surgery

Phase 4Unknown

NCT03759964

Effects of Ferinject® on Anemia and Transfusion Rates After Cardiac Surgery

Phase 4Completed

NCT03399084

A Study Comparing Two Ferric Carboxymaltose Formulations in Patients With Iron Deficiency Anemia

Phase 1Completed

NCT03632525

Intravenous Iron in Adults With Cystic Fibrosis

Phase 4Completed

NCT05309499

An Open Study on the Efficacy of Iron Therapy Using iv Iron Relative to Oral Iron for Increasing LV Systolic Function

Not ApplicableCompleted

NCT04269707

Efficacy and Safety of Intravenous Ferric Carboxymaltose in Pediatric Patients With Iron Deficiency Anemia and Unsatisfactory Response Oral Iron Under Study Protocol 1VIT17044

Phase 3Completed

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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)

You may not qualify if:

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.

Contact the study team to confirm eligibility.

December 2018

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

December 2018

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

March 20, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02800746
Data provider: ClinicalTrials.gov
Source updated: 2018-03-20
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:33:26 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Experimental group

Control Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record