NCT03094182 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

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.
Johansson PI, Rasmussen AS, Thomsen LL
Intravenous iron isomaltoside 1000 (Monofer®) 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.
Kalra PA, Bhandari S
Efficacy and safety of iron isomaltoside (Monofer(®)) 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. Review.
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. Review.
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.

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

Clinical trial NCT03094182 - References