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

March 15, 2019 updated by: Yonsei University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Bon-Nyeo Koo, M.D., Ph.D.
  • Phone Number: 82-2-2227-3919
  • Email: koobn@yuhs.ac

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Recruiting
        • Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine
        • Contact:
          • Bon-Nyeo Koo, M.D., Ph.D.
          • Phone Number: 02-2227-3835
          • Email: koobn@yuhs.ac

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: control group
Patients in the control group receive the same volume of normal saline during operation.
Drug: Normal saline
Randomly selected patients in the control group receive an equivalent volume of normal saline as a placebo.
Experimental: iron group
Patients in the iron group are given Intravenous iron isomaltoside during operation.
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.
Other Names:
  • monofer®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative hemoglobin level
Time Frame: 1 day after surgery
Postoperative hemoglobin concentration
1 day after surgery
postoperative hemoglobin level
Time Frame: 2 weeks after surgery
Postoperative hemoglobin concentration
2 weeks after surgery
postoperative hemoglobin level
Time Frame: 4 weeks after surgery
Postoperative hemoglobin concentration
4 weeks after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hematogenous function
Time Frame: 1 day after surgery
the hematogenous function measured by serum iron, ferritin, transferrin saturation, and total iron binding capacity, reticulocyte
1 day after surgery
hematogenous function
Time Frame: 2 weeks after surgery
the hematogenous function measured by serum iron, ferritin, transferrin saturation, and total iron binding capacity, reticulocyte
2 weeks after surgery
hematogenous function
Time Frame: 4 weeks after surgery
the hematogenous function measured by serum iron, ferritin, transferrin saturation, and total iron binding capacity, reticulocyte
4 weeks after surgery
quality of life(LASA)
Time Frame: 1 day after surgery

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
quality of life(LASA)
Time Frame: 2 weeks after surgery

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
quality of life(LASA)
Time Frame: 4 weeks after surgery

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2017

Primary Completion (Anticipated)

August 1, 2019

Study Completion (Anticipated)

August 1, 2019

Study Registration Dates

First Submitted

March 23, 2017

First Submitted That Met QC Criteria

March 23, 2017

First Posted (Actual)

March 29, 2017

Study Record Updates

Last Update Posted (Actual)

March 20, 2019

Last Update Submitted That Met QC Criteria

March 15, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2016-1146

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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