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Intravenous Iron Pre-treatment in Prognathic Surgery

K

Konkuk University Medical Center

Status

Unknown

Conditions

Prognathic Surgery

Treatments

Drug: Placebo
Drug: Ferric carboxymaltose

Study type

Interventional

Funder types

Other

Identifiers

NCT02800746
KUH1160000

Details and patient eligibility

About

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.

Enrollment

48 estimated patients

Sex

All

Ages

19+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

48 participants in 2 patient groups, including a placebo group

Experimental group
Experimental group
Description:
Ferric carboxymaltose
Treatment:
Drug: Ferric carboxymaltose
Control Group
Placebo Comparator group
Description:
Placebo
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Central trial contact

Tae-Yop Kim, MD, PhD

Data sourced from clinicaltrials.gov

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