Facial Asymmetry Clinical Trial
Official title:
Efficacy of Intravenous Iron Therapy in Maintaining Hemoglobin Concentration on Patients Undergoing Bimaxillary Orthognathic Surgery
NCT number | NCT03094182 |
Other study ID # | 4-2016-1146 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2, 2017 |
Est. completion date | August 2019 |
The aim of this study is to evaluate the effect of Intravenous iron isomaltoside on maintaining hemoglobin concentration in patients undergoing bimaxillary orthognathic surgery. Fifty-eight patients, aged 19 to 40 years, scheduled for Bimaxillary orthognathic surgery will be divided into monofer (n=29) and control (n=29) groups. Randomly selected patients of the ulinastatin group are given intravenous iron isomaltoside. In contrast, patients in the control group receive an equivalent volume of normal saline as a placebo. The primary endpoints are postoperative hemoglobin concentration.
Status | Recruiting |
Enrollment | 58 |
Est. completion date | August 2019 |
Est. primary completion date | August 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 40 Years |
Eligibility |
Inclusion Criteria: - patients who are scheduled to undergo bimaxillary orthognathic surgery - American Society of Anesthesiologists (ASA) physical status I-II Exclusion Criteria: - hematologic disease - renal-related anemia - hepatitis - pregnancy - hypersensitivity to iron - severe atopic disease - allergic to drugs |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine | Seoul |
Lead Sponsor | Collaborator |
---|---|
Yonsei University |
Korea, Republic of,
Choi BK, Yang EJ, Oh KS, Lo LJ. Assessment of blood loss and need for transfusion during bimaxillary surgery with or without maxillary setback. J Oral Maxillofac Surg. 2013 Feb;71(2):358-65. doi: 10.1016/j.joms.2012.04.012. Epub 2012 Jun 16. — View Citation
Johansson PI, Rasmussen AS, Thomsen LL. Intravenous iron isomaltoside 1000 (Monofer®) reduces postoperative anaemia in preoperatively non-anaemic patients undergoing elective or subacute coronary artery bypass graft, valve replacement or a combination thereof: a randomized double-blind placebo-controlled clinical trial (the PROTECT trial). Vox Sang. 2015 Oct;109(3):257-66. doi: 10.1111/vox.12278. Epub 2015 Apr 20. — View Citation
Kalra PA, Bhandari S. Efficacy and safety of iron isomaltoside (Monofer(®)) in the management of patients with iron deficiency anemia. Int J Nephrol Renovasc Dis. 2016 Mar 10;9:53-64. doi: 10.2147/IJNRD.S89704. eCollection 2016. Review. — View Citation
Litton E, Xiao J, Ho KM. Safety and efficacy of intravenous iron therapy in reducing requirement for allogeneic blood transfusion: systematic review and meta-analysis of randomised clinical trials. BMJ. 2013 Aug 15;347:f4822. doi: 10.1136/bmj.f4822. Review. — View Citation
Oh AY, Seo KS, Lee GE, Kim HJ. Effect of preoperative autologous blood donation on patients undergoing bimaxillary orthognathic surgery: a retrospective analysis. Int J Oral Maxillofac Surg. 2016 Apr;45(4):486-9. doi: 10.1016/j.ijom.2015.11.008. Epub 2015 Dec 8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | postoperative hemoglobin level | Postoperative hemoglobin concentration | 1 day after surgery | |
Primary | postoperative hemoglobin level | Postoperative hemoglobin concentration | 2 weeks after surgery | |
Primary | postoperative hemoglobin level | Postoperative hemoglobin concentration | 4 weeks after surgery | |
Secondary | hematogenous function | the hematogenous function measured by serum iron, ferritin, transferrin saturation, and total iron binding capacity, reticulocyte | 1 day after surgery | |
Secondary | hematogenous function | the hematogenous function measured by serum iron, ferritin, transferrin saturation, and total iron binding capacity, reticulocyte | 2 weeks after surgery | |
Secondary | hematogenous function | the hematogenous function measured by serum iron, ferritin, transferrin saturation, and total iron binding capacity, reticulocyte | 4 weeks after surgery | |
Secondary | quality of life(LASA) | The quality of life measured by LASA(Linear Analogue Self Assessment) questionnaire. LASA includes five simple items, each of which targets a specific domain of quality of life. Five single items(overall, physical, emotional, spiritual, intellectual) asking respondents to rate, on zero to ten scales, their perceived level of functioning. |
1 day after surgery | |
Secondary | quality of life(LASA) | The quality of life measured by LASA(Linear Analogue Self Assessment) questionnaire. LASA includes five simple items, each of which targets a specific domain of quality of life. Five single items(overall, physical, emotional, spiritual, intellectual) asking respondents to rate, on zero to ten scales, their perceived level of functioning. |
2 weeks after surgery | |
Secondary | quality of life(LASA) | The quality of life measured by LASA(Linear Analogue Self Assessment) questionnaire. LASA includes five simple items, each of which targets a specific domain of quality of life. Five single items(overall, physical, emotional, spiritual, intellectual) asking respondents to rate, on zero to ten scales, their perceived level of functioning. |
4 weeks after surgery |
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