Comparison between intravenous iron therapy and autologous blood transfusion on postoperative anemia in patients undergoing two-jaws orthognathic surgery
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Registration Number
- KCT0003680
- Lead Sponsor
- The Catholic University of Korea, Seoul St. Mary's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 66
1. An adult patient scheduled for a Le Fort II osteotomy (more than 19 years-old)
2. American Society of Anesthesiologists (ASA) class I or II
3. Patients is clinically tolerable to treat with autologous whole blood donation (Hemoglobin is more than 11 g/dL).
1. Disagree to participate in this study
2. Emergency surgery
3. Contraindication for intravenous iron adminisration
1) Hypersensitivity or allergy reaction to intravenous iron
2) Hypersensitivity or allergy reaction to other parenteral iron
3) Anemia other than iron deficiency (eg, microcytic anemia)
4) High serum iron level or disability of iron use
5) Bacteremia
6) Liver dysfunction
7) Acute or chronic infection
8) Asthma, eczema, atopic allergies
9) Allergy vulnerable patients, including drug allergy
10) Immune or inflammatory diseases (eg, systemic lupus erythematosus lupus, rheumatoid arthritis)
11) Pregnancy
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hemoglobin
- Secondary Outcome Measures
Name Time Method Postoperative complications using Clavien-Dindo classification;Total period of hospital admission;C-reactive protein; white blood cell; red blood cell; hematocrit; platelet; neutrophil; lymphocyte; monocyte; eosinophil; basophil; mean corpuscular volume; mean copuscular hemoglobin; mean corpuscular hemoglobin concentration; prothrombin time; international normalized raio; activated partial thrombin time; fibrinogen; antithrombin III; D-dimer; fibrinogen degradation product; iron; ferritin; total iron binding capacity;systolic and diastolic blood pressure, heart rate and body temperature;Satisfaction with interventions (autologous blood collection vs. intravenous iron administration) using visual analogue sclae (VAS) score