Comparison between intravenous iron therapy and autologous blood transfusion on postoperative anemia in patients undergoing two-jaws orthognathic surgery

Comparison of effects of intravenous iron therapy and autologous blood transfusion on postoperative anemia in patients undergoing two-jaws orthognathic surgery

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0003680

Enrollment

Registered

2019-03-27

Start date

2019-03-27

Completion date

Unknown

Last updated

2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : *Experimental group Intervention protocol 1.Drug name: Ferinject (component: carboxymaltose hydroxide ferric chloride) 2.Dose: 1 Vial (iron content 500 mg) 3.Frequency and duration: single admi

normal saline (100mL) and infused during 30 min via intravenous approach. We investigate the effect of the intervention therapy (Ferinject 1 vial (iron 500mg) mixed to 0.6&#37

normal saline total 100mL is administered during 30 min on 4 weeks before the two-jaws surgery) on reducing the incidence of postoperative anemia and the requirement of blood product transfusion, such

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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).

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Hemoglobin	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Korea, Republic of

Contacts

Public ContactMin Suk Chae

The Catholic University of Korea, Seoul St. Mary's Hospital

Outcome results