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

Primary Purpose

Facial Asymmetry, Retrognathism, Prognathism

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Iron Isomaltoside 1000
Normal saline
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Facial Asymmetry

Eligibility Criteria

19 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

iron group

control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

postoperative hemoglobin level
Postoperative hemoglobin concentration
postoperative hemoglobin level
Postoperative hemoglobin concentration
postoperative hemoglobin level
Postoperative hemoglobin concentration

Secondary Outcome Measures

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

Full Information

First Posted
March 23, 2017
Last Updated
March 15, 2019
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT03094182
Brief Title
Efficacy of Intravenous Iron Therapy in Maintaining Hemoglobin Concentration on Patients Undergoing Bimaxillary Orthognathic Surgery
Official Title
Efficacy of Intravenous Iron Therapy in Maintaining Hemoglobin Concentration on Patients Undergoing Bimaxillary Orthognathic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 2, 2017 (Actual)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
August 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Facial Asymmetry, Retrognathism, Prognathism

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
iron group
Arm Type
Experimental
Arm Description
Patients in the iron group are given Intravenous iron isomaltoside during operation.
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
Patients in the control group receive the same volume of normal saline during operation.
Intervention Type
Drug
Intervention Name(s)
Iron Isomaltoside 1000
Other Intervention Name(s)
monofer®
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Randomly selected patients in the control group receive an equivalent volume of normal saline as a placebo.
Primary Outcome Measure Information:
Title
postoperative hemoglobin level
Description
Postoperative hemoglobin concentration
Time Frame
1 day after surgery
Title
postoperative hemoglobin level
Description
Postoperative hemoglobin concentration
Time Frame
2 weeks after surgery
Title
postoperative hemoglobin level
Description
Postoperative hemoglobin concentration
Time Frame
4 weeks after surgery
Secondary Outcome Measure Information:
Title
hematogenous function
Description
the hematogenous function measured by serum iron, ferritin, transferrin saturation, and total iron binding capacity, reticulocyte
Time Frame
1 day after surgery
Title
hematogenous function
Description
the hematogenous function measured by serum iron, ferritin, transferrin saturation, and total iron binding capacity, reticulocyte
Time Frame
2 weeks after surgery
Title
hematogenous function
Description
the hematogenous function measured by serum iron, ferritin, transferrin saturation, and total iron binding capacity, reticulocyte
Time Frame
4 weeks after surgery
Title
quality of life(LASA)
Description
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.
Time Frame
1 day after surgery
Title
quality of life(LASA)
Description
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.
Time Frame
2 weeks after surgery
Title
quality of life(LASA)
Description
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.
Time Frame
4 weeks after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bon-Nyeo Koo, M.D., Ph.D.
Phone
82-2-2227-3919
Email
koobn@yuhs.ac
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bon-Nyeo Koo, M.D., Ph.D.
Phone
02-2227-3835
Email
koobn@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25900643
Citation
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.
Results Reference
background
PubMed Identifier
27022297
Citation
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.
Results Reference
background
PubMed Identifier
26678802
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.
Results Reference
background
PubMed Identifier
23950195
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.
Results Reference
background
PubMed Identifier
22705218
Citation
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.
Results Reference
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Efficacy of Intravenous Iron Therapy in Maintaining Hemoglobin Concentration on Patients Undergoing Bimaxillary Orthognathic Surgery

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