Preventive EXACYL® on Perioperative Bleeding During Orthognathism of Maxillary Surgery

Phase 3 Completed 157 enrolled University Hospital, Lille

RandomizedParallel-groupQuadruple-blindPrevention

Summary

Prospective, randomized, double-blind, placebo-controlled, mono center, Phase III trial to compare EXACYL in preventive with placebo on perioperatory bleeding in orthognathism surgery.

Timeline

Start: 2016-01-03
Primary completion: 2018-06-30
Completion: 2018-06-30

Publications

Results Jozefowicz E, Sabourdin N, Lambelin V, Lejeune V, Delassus R, Tavernier B. The effect of tranexamic acid on blood loss in orthognathic surgery: a randomized, placebo-controlled, equivalence study. Int J Oral Maxillofac Surg. 2022 May;51(5):637-642. doi: 10.1016/j.ijom.2021.08.018. Epub 2021 Aug 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Tranexamic Acid	Small molecule	1 g	—

Indications

No indication recorded.