Assessment of the effect of rivaroxaban on sudden sensorineural hearing loss

Phase 3

• Conditions: Idiopathic Sudden Sensorineural Hearing Loss.; Sudden idiopathic hearing loss, unspecified ear; H91.20

• Registration Number: IRCT20200708048051N1
• Lead Sponsor: Rasht University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 August 2020

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Patients with a unilateral sudden sensory hearing loss
Refer to the hospital in less than 5 days from the onset of symptoms
Hearing loss of = 30 dB at least 3 consecutive frequencies in the audiometery.

Exclusion Criteria

Patients with a history of hearing loss, trauma to the ear, active ear infection, congenital cochlear disease
Use of ototoxic drugs, anticoagulants, anticonvulsants.
Cardiovascular disease, coagulation disorders, and diabetes.
Retro cochlear lesions
Severe renal and hepatic impairment (Cr clearance less than 15)
People with neoplasms who have not been treated or are being treated with chemotherapy or radiotherapy.
pregnancy and breastfeeding
Patients with history of autoimmune disorder
Patients with platelet count disorder (less than 150,000)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hearing threshold. Timepoint: Before starting treatment and 2 weeks after and 3 months after starting treatment. Method of measurement: Pure tone audiometry.