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Facial AsymmetryNCT03094182

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

A study testing Iron Isomaltoside 1000 and Normal saline in people with Facial Asymmetry and Retrognathism, run by Yonsei University at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 19 to 40 years
Conditions the study is for
Facial Asymmetry, Retrognathism, Prognathism
What is being tested?
Iron Isomaltoside 1000 and Normal saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
58 participants
Where
1 siteSouth Korea
Study dates
2 Mar 2017to Aug 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

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

82-2-2227-3919

koobn@yuhs.ac

South Korea1 site, 1 recruiting

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

    Seoul, 03722

    Bon-Nyeo Koo, M.D., Ph.D., 02-2227-3835, koobn@yuhs.ac

    Recruiting

Other trials in South Korea

About this study

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.

Read the detailed 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.

Being tested
Iron Isomaltoside 1000, Normal saline
Medical subject headings
Facial Asymmetry, Retrognathia, Prognathism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Iron Isomaltoside 1000Drug

    Also called monofer®

    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 salineDrug

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

Study groups in NCT03094182
Study groupRoleWhat they receive
iron groupExperimentalPatients in the iron group are given Intravenous iron isomaltoside during operation.
Receives: Drug: Iron Isomaltoside 1000
control groupPlacebo comparatorPatients in the control group receive the same volume of normal saline during operation.
Receives: Drug: Normal saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. postoperative hemoglobin level

    Postoperative hemoglobin concentration

    Measured: 1 day after surgery

  2. postoperative hemoglobin level

    Postoperative hemoglobin concentration

    Measured: 2 weeks after surgery

  3. postoperative hemoglobin level

    Postoperative hemoglobin concentration

    Measured: 4 weeks after surgery

Secondary outcomes (6)

  1. hematogenous function

    the hematogenous function measured by serum iron, ferritin, transferrin saturation, and total iron binding capacity, reticulocyte

    Measured: 1 day after surgery

  2. hematogenous function

    the hematogenous function measured by serum iron, ferritin, transferrin saturation, and total iron binding capacity, reticulocyte

    Measured: 2 weeks after surgery

  3. hematogenous function

    the hematogenous function measured by serum iron, ferritin, transferrin saturation, and total iron binding capacity, reticulocyte

    Measured: 4 weeks after surgery

  4. 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.

    Measured: 1 day after surgery

  5. 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.

    Measured: 2 weeks after surgery

  6. 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.

    Measured: 4 weeks after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2017
  2. Study start2 Mar 2017
  3. Primary completionAug 2019 (estimated)
  4. Study completionAug 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
58 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03094182
Sponsor's protocol ID
4-2016-1146
Status last verified
Mar 2019
First submitted
23 Mar 2017
Last updated
20 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25900643

  • 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.

    PubMed 27022297

  • 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.

    PubMed 26678802

  • 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.

    PubMed 23950195

  • 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.

    PubMed 22705218

Questions about this trial

What is this clinical trial studying?

A study testing Iron Isomaltoside 1000 and Normal saline in people with Facial Asymmetry and Retrognathism, run by Yonsei University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Bon-Nyeo Koo, M.D., Ph.D. (82-2-2227-3919, koobn@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

postoperative hemoglobin level (time frame: 1 day after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03094182, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2019.

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