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Role of topical Tranexamic acid versus topical Epinephrine on bleeding control in Endoscopic Ear Surgeries

A Randomized Control Trial on effect of topical Tranexamic acid versus topical Epinephrine on bleeding in Endoscopic Ear Surgeries

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/10/037170
Enrollment
60
Registered
2021-10-07
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Interventions

Intervention1: Topical Tranexamic acid: Small Cotton pledgets of 0.5-1cm diameter, soaked in Tranexamic acid will be placed locally in middle ear or on tympanomeatal flap in cases of bleeding during s

Sponsors

Dr Asutosh Adhikari
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with chronic otitis media (COM) of mucosal type undergoing Endoscopic Tympanoplasty, Patients undergoing Endoscopic Ossiculoplasty without mastoidectomy, Patients undergoing Endoscopic Stapedotomy

Exclusion criteria

Exclusion criteria: Patients having COM of squamous type, history of past ear surgery/ revision cases, COM with intracranial complication, patients below 12 years, allergy to TXA, bleeding or coagulation disorders, acute and chronic renal failure, heparin use within 48 h before the study or aspirin use within seven days before surgery, pregnancy, liver cirrhosis, patients with cardiac stents

Design outcomes

Primary

MeasureTime frame
Intraoperative bleeding will be measured by difference in weights of cotton pledgets preoperatively and postoperatively. And amount of bleeding in suction machine if any.Timepoint: Baseline

Secondary

MeasureTime frame
Operative timeTimepoint: Intraoperative;Post-operative Improvement in hearing with Pure tone audiometry resultsTimepoint: 1 and half months postoperatively

Countries

India

Contacts

Public ContactDr Saurav Sarkar

AIIMS, Bhubaneswar

doc.sauravsarkar@gmail.com9830315933

Outcome results

None listed

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