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

NCT03094182 | Unknown

• 1 other identifier: 4-2016-1146
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Facial Asymmetry; Retrognathism; Prognathism

Outcome Measures

Primary Outcomes (3)

• postoperative hemoglobin level

  Postoperative hemoglobin concentration

  1 day after surgery

• postoperative hemoglobin level

  Postoperative hemoglobin concentration

  2 weeks after surgery

• postoperative hemoglobin level

  Postoperative hemoglobin concentration

  4 weeks after surgery

Secondary Outcomes (6)

• hematogenous function

  1 day after surgery

• hematogenous function

  2 weeks after surgery

• hematogenous function

  4 weeks after surgery

• quality of life(LASA)

  1 day after surgery

• quality of life(LASA)

  2 weeks after surgery

Study Arms (2)

iron group

EXPERIMENTAL

Patients in the iron group are given Intravenous iron isomaltoside during operation.

Drug: Iron Isomaltoside 1000

control group

PLACEBO COMPARATOR

Patients in the control group receive the same volume of normal saline during operation.

Drug: Normal saline

Interventions

Iron Isomaltoside 1000 DRUG

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.

Also known as: monofer®

iron group

Normal saline DRUG

Randomly selected patients in the control group receive an equivalent volume of normal saline as a placebo.

control group

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients who are scheduled to undergo bimaxillary orthognathic surgery
• American Society of Anesthesiologists (ASA) physical status I-II

You may not qualify if:

• hematologic disease
• renal-related anemia
• hepatitis
• pregnancy
• hypersensitivity to iron
• severe atopic disease
• allergic to drugs

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine

Seoul, 03722, South Korea

RECRUITING

Related Publications (5)

• Johansson PI, Rasmussen AS, Thomsen LL. Intravenous iron isomaltoside 1000 (Monofer(R)) 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.

  PMID: 25900643 BACKGROUND

• Kalra PA, Bhandari S. Efficacy and safety of iron isomaltoside (Monofer((R))) 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.

  PMID: 27022297 BACKGROUND

• 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.

  PMID: 26678802 BACKGROUND

• 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.

  PMID: 23950195 BACKGROUND

• 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.

  PMID: 22705218 BACKGROUND

MeSH Terms

Conditions

Facial Asymmetry; Retrognathia; Prognathism

Interventions

iron isomaltoside 1000; Saline Solution

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mandibular Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Bon-Nyeo Koo, M.D., Ph.D.

CONTACT

82-2-2227-3919; koobn@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2017
• First Posted: March 29, 2017
• Study Start: March 2, 2017
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: March 20, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)