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Efficacy of Tranexamic acid in control of bleeding in Microscopic ear surgeries - A Randomized Control Study

Efficacy of Tranexamic acid in control of bleeding in Modified Radical Mastoidectomy and Tympanoplasty - A Randomized Control Study - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/03/106905
Enrollment
100
Registered
2026-03-25
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H661- Chronic tubotympanic suppurative otitis media Health Condition 2: H662- Chronic atticoantral suppurative otitis media

Interventions

Intervention1: Tranexamic Acid: 1gm Tranexamic acid in 100 ml Normal Saline over 10 mins to be injected just before incision Control Intervention1: 100 ML SALINE: 100 ML SALINE JUST BEFORE INCISION OV

Sponsors

Kasturba Medical College Manipal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All patients aged 18-65 years 2. Planned for Modified Radical Mastoidectomy and Tympanoplasty

Exclusion criteria

Exclusion criteria: 1. Less than 18 years age and more than 65 years age 2. Known allergy to Tranexamic acid 3. ASA physical status more than or equal to 3 4. Known cases of Liver or Kidney diseases and Cardiocerebrovascular problems 5. Known Thromboembolic disorders 6. Known Seizure disorder 7. Known Coagulation dysfunction 8. Use of Anticoagulants 9. Pregnancy and Lactation 10. Lack of patient consent 11. Any additional procedures to be performed simultaneously

Design outcomes

Primary

MeasureTime frame
- To study efficacy of Tranexamic Acid in reducing bleeding during Modified Radical Mastoidectomy and TympanoplastyTimepoint: 24 hours

Secondary

MeasureTime frame
- To study Surgeon s satisfaction with the surgical field after using Tranexamic acid during Modified Radical Mastoidectomy & TympanoplastyTimepoint: 24 hours;- To study the Reduction in operating time on use of Tranexamic acid during Modified Radical Mastoidectomy & TympanoplastyTimepoint: 24 hours

Countries

India

Contacts

Public ContactDr Kailesh Pujary

Kasturba Medical College, Manipal

09chanda28@gmail.com7572060282

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026