Topical and Local TXA in Facelifts - A Randomized Controlled Double Blinded Study

Study Identifier:
ENT-2024-32847
ClinicalTrials.gov Identifier:
NCT06345833
EudraCT Identifier:
N/A
Recruiting

Study Details

Medical Condition
  • Hemophilia
  • Unmapped
Study Drug
  • Drug: 1%Tranexamic acid with standard local
  • Drug: 3% TXA
  • Drug: 1% TXA with local plus 3% TXA-soaked pledgets
Date
Jul 2024 - Jul 2026
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Inclusion Criteria:
  • Eligible participants will consist of all regular clinic patients who elect and are deemed fit by the surgeon to undergo facelift surgery, including patients undergoing ancillary procedures
  • age 18 and older
  • English speaking.
  • Exclusion Criteria:
  • younger than 18
  • previously had an adverse reaction to tranexamic acid
  • non-English speaking
  • patients who elect not to participate or withdraw from the study.

Protocol Summary

This study is looking at how safe it is to switch from emicizumab to Mim8, in people with haemophilia A. Mim8 is a new medicine that is used to prevent bleeding episodes in people with haemophilia A. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). Mim8 will be injected under the skin using a pen-injector either once every week, once every two weeks or once every month. The participants will be trained in using the pen injector. The participants can choose themselves, in collaboration with the study doctor how often they get Mim8 in this study. When the participant will get their first Mim8 injection depends on their current treatment with emicizumab. The participants will get their first Mim8 injection at Visit 2. Participants will have between 6 and 27 Mim8 injections. The total number of injections participants will have depends on their dosing frequency. The study will last for about 6-12 months. While taking part in this study, there are some restrictions about what medicine participant can use. The study doctor will tell the participants more about this. In case the participants experience bleeds, these can be treated with additional haemostatic medicine as agreed with the study doctor. Female participants cannot take part if they are pregnant, breast-feeding or plan to get pregnant during the study period.

Trial Locations

Location
Status
Location
University of Minnesota
Minneapolis, Minnesota, United States, 55414
Status
Recruiting