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

Konkuk University Medical Center0 sites48 target enrollmentJune 2018

ConditionsPrognathic Surgery

InterventionsFerric carboxymaltose Placebo

DrugsFerric carboxymaltose Placebo

Overview

Phase: Not Applicable
Intervention: Ferric carboxymaltose
Conditions: Prognathic Surgery
Sponsor: Konkuk University Medical Center
Enrollment: 48
Primary Endpoint: Serum-Hematocrit
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2018

End Date

December 2018

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Konkuk University Medical Center

Responsible Party

Principal Investigator

Tae-Yop Kim, MD PhD

Professor

Konkuk University Medical Center

Eligibility Criteria

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.