Comparing topical and intravenous tranexamic acid for blood loss control during surgery
Efficacy of Topical Versus Intravenous Tranexamic Acid in Controlling Blood Loss in Patients Undergoing:Total Laryngectomy With Neck Dissection. A Randomized Control Study.
PHASE4 · Kasr El Aini Hospital · NCT06188052
This study is testing whether using a gel form of tranexamic acid can help control bleeding during throat surgery better than giving it through an IV.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Kasr El Aini Hospital (other) |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06188052 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of topical tranexamic acid compared to intravenous administration in controlling blood loss during total laryngectomy surgeries. A total of 45 patients will be enrolled and divided into three groups: one receiving intravenous tranexamic acid, one receiving topical tranexamic acid, and a control group receiving normal saline. The aim is to determine if topical application can reduce intraoperative bleeding without the risks associated with intravenous administration. The study will monitor blood loss immediately postoperatively to assess the efficacy of the interventions.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18-70 years with ASA physical status I or II who are scheduled for total laryngectomy.
Not a fit: Patients with coagulopathy, a history of thromboembolism, or those allergic to tranexamic acid will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could minimize intraoperative bleeding and improve surgical outcomes for patients undergoing total laryngectomy.
How similar studies have performed: Other studies have shown positive outcomes with tranexamic acid in reducing surgical bleeding, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: - Patients of either sex, aged between 18-70 years old, ASA physical status I, II undergoing total laryngectomy Exclusion Criteria: * Patients with coagulopathy, a history of thromboembolism or a history of tranexamic acid allergy or complication will be excluded.
Where this trial is running
Cairo
- Cairo University hospitals — Cairo, Egypt (RECRUITING)
Study contacts
- Principal investigator: Dina M Mohamed, MD — Cairo University Hospitals
- Study coordinator: Dina M Mohamed, Lecturer
- Email: Dinamahmoud@kasralainy.edu.eg
- Phone: 01005249134
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: To Calculate Total Blood Loss Immediately Postoperative