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Status unknownNCT02800746Updated Mar 20, 2018

Intravenous Iron Pre-treatment in Prognathic Surgery

An interventional study of Ferric carboxymaltose and Placebo in Prognathic Surgery, sponsored by Konkuk University Medical Center. Status unknown. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-20.

Sponsored by Konkuk University Medical Center · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Prognathic Surgery

Keywords

  • Prognathic surgery
  • intravenous iron
03

In context

Lead sponsor

Konkuk University Medical Center is the lead sponsor of 93 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
48 participants (estimated)

Study arms

  • Experimental
    Experimental group

    Ferric carboxymaltose

    Drug: Ferric carboxymaltose

  • Placebo comparator
    Control Group

    Placebo

    Drug: Placebo

Interventions

  • DrugFerric carboxymaltose

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

  • DrugPlacebo

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

    Also known as: normal saline

06

What researchers measure

Primary outcomes

  1. Serum-Hematocrit

    intergroup-difference immediately after surgery, %

    Time frame: Postoperative 2 hour

Secondary outcomes

  1. Serum-Ferritin level

    intergroup-difference in postoperative hematocrit level, %

    Time frame: Postoperative 2 hour

  2. Changes of serum-Ferritin level

    Intragroup-difference in the s-ferritin before and immediately after surgery, mg/dl

    Time frame: Postoperative 2 hour

  3. Transfusion amount

    intergroup-difference in the amount of packed RBC transfused during surgery, unit

    Time frame: Postoperative 2 hour

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02800746
Lead sponsor
Konkuk University Medical Center
Responsible party
Tae-Yop Kim, MD PhD (Professor, Konkuk University Medical Center) — Principal investigator
First posted
Jun 15, 2016
Start date
Jun 2018 (estimated)
Primary completion
Dec 2018 (estimated)
Completion
Dec 2018 (estimated)
Last update
Mar 20, 2018

Study contacts

Tae-Yop Kim, MD, PhD
Contact
taeyop@gmail.com
82-2-2030-5445

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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