Efficacy of Topical Versus Intravenous Tranexamic Acid in Controlling Blood Loss in Patients Undergoing:Total Laryngectomy With Neck Dissection. A Randomized Control Study.
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
Total laryngectomy with bilateral block neck dissection is considered one of the major head and neck surgeries. Intraoperative bleeding is considered a risk factor for this operation specially that the population of this operation are elder with multiple comorbidities. Intravenous administration of tranexamic acid reduces bleeding during surgery.We design this study aiming to prove the role of topical tranexamic acid in controlling the intraoperative bleeding in patients undergoing total laryngectomy operation avoiding the risk of intravenous administration.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• \- Patients of either sex, aged between 18-70 years old, ASA physical status I, II undergoing total laryngectomy
Locations
Other Locations
Egypt
Cairo University hospitals
RECRUITING
Cairo
Contact Information
Primary
Dina M Mohamed, Lecturer
Dinamahmoud@kasralainy.edu.eg
01005249134
Backup
Amr H Sayed, professor
amr.hussein.sayed@gmail.com
01069338998
Time Frame
Start Date: 2023-08-01
Estimated Completion Date: 2024-01-31
Participants
Target number of participants: 45
Treatments
Active_comparator: Group (A), tranexamic acid IV
tranexamic acid will be given 1 hr preoperatively as 1mg/kg intravenously
Active_comparator: Group (B), topical tranexamic acid
topical tranexamic acid will be given as an irrigation by 40 ml of tranexamic acid 2mg/kg dissolved in 200ml to the surgical site every 1 hour for the first 5 hours .
Placebo_comparator: Group (C), control group.
Saline will be given intravenously instead of tranexamic acid And irrigation with Saline instead of tranexamic acid
Related Therapeutic Areas
Sponsors
Leads: Kasr El Aini Hospital