Intravenous Iron Pre-treatment in Prognathic Surgery

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

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.

Study Overview

• Status: Unknown
• Conditions: Prognathic Surgery
• Intervention / Treatment: Drug: Ferric carboxymaltose; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental group; Ferric carboxymaltose	Drug: Ferric carboxymaltose; Ferric carboxymaltose 15 mg/kg mg is intravenously administered on 7-10 day before surgery.
PLACEBO_COMPARATOR: Control Group; Placebo	Drug: Placebo; normal saline 100 ml is intravenously administered on 7-10 day before surgery; Other Names: normal saline

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Konkuk University Medical Center

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2018
• Primary Completion (ANTICIPATED): December 1, 2018
• Study Completion (ANTICIPATED): December 1, 2018

Study Registration Dates

• First Submitted: June 11, 2016
• First Submitted That Met QC Criteria: June 11, 2016
• First Posted (ESTIMATE): June 15, 2016

Study Record Updates

• Last Update Posted (ACTUAL): March 20, 2018
• Last Update Submitted That Met QC Criteria: March 19, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: intravenous iron; Prognathic surgery
• Other Study ID Numbers: KUH1160000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No