Efficacy of Intravenous Iron Therapy in Maintaining Hemoglobin Concentration on Patients Undergoing Bimaxillary Orthognathic Surgery

Facial Asymmetry Clinical Trial

Official title:

Efficacy of Intravenous Iron Therapy in Maintaining Hemoglobin Concentration on Patients Undergoing Bimaxillary Orthognathic Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03094182
• Other study ID #: 4-2016-1146
• Status: Recruiting
• Phase: N/A
• Start date: March 2, 2017
• Est. completion date: August 2019

Study information

• Verified date: March 2019
• Source: Yonsei University
• Contact: Bon-Nyeo Koo, M.D., Ph.D.
• Phone: 82-2-2227-3919
• Email: koobn[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Bimaxillary orthognathic surgery is widely used to correct dentofacial anomaly and bimaxillary prognathism. However, the complicated vascularity of the surgical site and limited visual field can lead to unexpected bleeding. Intravenous iron isomaltoside 1000 (monofer®) significantly increased the hemoglobin level and prevented anemia 4 weeks after cardiac surgery. 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Facial Asymmetry
• Prognathism
• Retrognathia
• Retrognathism

Intervention

Drug:
• Iron Isomaltoside 1000
Randomly selected patients of the monofer group are given 1000mg of iron isomaltoside, which are mixed in 100ml normal saline, intravenous after induction for 30 minutes.
• Normal saline
Randomly selected patients in the control group receive an equivalent volume of normal saline as a placebo.

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (5)

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

Outcome

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