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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Yonsei University

Current Primary Outcome:

  • postoperative hemoglobin level [ Time Frame: 1 day after surgery ]
    Postoperative hemoglobin concentration
  • postoperative hemoglobin level [ Time Frame: 2 weeks after surgery ]
    Postoperative hemoglobin concentration
  • postoperative hemoglobin level [ Time Frame: 4 weeks after surgery ]
    Postoperative hemoglobin concentration


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • hematogenous function [ Time Frame: 1 day after surgery ]
    the hematogenous function measured by serum iron, ferritin, transferrin saturation, and total iron binding capacity, reticulocyte
  • hematogenous function [ Time Frame: 2 weeks after surgery ]
    the hematogenous function measured by serum iron, ferritin, transferrin saturation, and total iron binding capacity, reticulocyte
  • hematogenous function [ Time Frame: 4 weeks after surgery ]
    the hematogenous function measured by serum iron, ferritin, transferrin saturation, and total iron binding capacity, reticulocyte
  • quality of life [ Time Frame: 1 day after surgery ]
    the quality of life measured by LASA(Linear Analogue Self Assessment) questionnaire
  • quality of life [ Time Frame: 2 weeks after surgery ]
    the quality of life measured by LASA(Linear Analogue Self Assessment) questionnaire
  • quality of life [ Time Frame: 4 weeks after surgery ]
    the quality of life measured by LASA(Linear Analogue Self Assessment) questionnaire


Original Secondary Outcome: Same as current

Information By: Yonsei University

Dates:
Date Received: March 23, 2017
Date Started: March 2, 2017
Date Completion: September 2018
Last Updated: March 23, 2017
Last Verified: March 2017