Intravenous Iron Pre-treatment in Prognathic Surgery
- Registration Number
- NCT02800746
- Lead Sponsor
- Konkuk University Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 48
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group Ferric carboxymaltose Ferric carboxymaltose Control Group Placebo Placebo
- Primary Outcome Measures
Name Time Method Serum-Hematocrit Postoperative 2 hour intergroup-difference immediately after surgery, %
- Secondary Outcome Measures
Name Time Method 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