Intravenous Iron Pre-treatment in Prognathic Surgery

Preoperative Intravenous Iron Supplementation on Postoperative Hematocrit and Intraoperative Transfusion Amount in Prognathic Surgery

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02800746

Enrollment

Registered

2016-06-15

Start date

2018-06-30

Completion date

2018-12-31

Last updated

2018-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prognathic Surgery

Keywords

Prognathic surgery, intravenous iron

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.

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

* 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.

Design outcomes

Primary

Measure	Time frame	Description
Serum-Hematocrit	Postoperative 2 hour	intergroup-difference immediately after surgery, %

Secondary

Measure	Time frame	Description
Serum-Ferritin level	Postoperative 2 hour	intergroup-difference in postoperative hematocrit level, %
Changes of serum-Ferritin level	Postoperative 2 hour	Intragroup-difference in the s-ferritin before and immediately after surgery, mg/dl
Transfusion amount	Postoperative 2 hour	intergroup-difference in the amount of packed RBC transfused during surgery, unit

Contacts

Primary ContactTae-Yop Kim, MD, PhD

taeyop@gmail.com82-2-2030-5445

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026