Intravenous Iron Pre-treatment in Prognathic Surgery

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

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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