Assessment of The Efficacy of Intratympanic Platelet Rich Plasma for Treatment of Sensorineural Hearing Loss.

NCT05786378 | Unknown Phase 2

• 1 other identifier: Intratympanic PRP
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

Assessment of the efficacy of Intratympanic platelet rich plasma injection for treatment of idiopathic suden sensorineural hearing loss

Conditions

Hearing Loss, Sudden; Hearing Loss, Sensorineural; Hearing Loss

Outcome Measures

Primary Outcomes (1)

• Changes in Pure Tone Averages

  Continuous pure tone averages calculated from pure tone audiometry will be summarized using the mean, standard deviation, median, 25th percentile, 75th percentile, minimum and maximum.

  6 weeks

Study Arms (1)

platlet rich plasma

EXPERIMENTAL

Biological: Platelet Rich Plasma; Drug: local anesthesia in external auditory canal; Procedure: Intratympanic Injection

Interventions

Platelet Rich Plasma BIOLOGICAL

Sample of patient's blood drawn at time of Treatment; the blood drawing occurs with addition of anticoagulant such as citrate dextrose A to prevent platelet activation prior to its use. Obtain whole blood by venipuncture in acid citrate dextrose (ACD) tubes. Centrifuge the blood using a 'soft' spin. Transfer the supernatant plasma containing platelets into another sterile tube (without anticoagulant). Centrifuge tube at a higher speed (a hard spin) to obtain a platelet concentrate. The lower 1/3rd is PRP and upper 2/3rd is platelet-poor plasma (PPP). At the bottom of the tube, platelet pellets are formed. PRP activation prior to injection. PRP can be activated exogenously by calcium chloride.

platlet rich plasma

local anesthesia in external auditory canal DRUG

local anesthesia cream (lidocaine cream) will be applied in external auditory canal for 15 minutes

platlet rich plasma

Intratympanic Injection PROCEDURE

0.5-1 ml of PRP will be injected in middle ear cavity in round window niche Using microscope or endoscope.

platlet rich plasma

Eligibility Criteria

• Age: 5 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients have sudden idiopathic sensorineural hearing loss

You may not qualify if:

• patients has previous ear surgery.
• patients has absent cochlea in CT or MRI
• patients has Cancer,Chronic liver disease, Hemodynamic instability,Hypofibrinogenemia, Platelet dysfunction syndromes, Systemic disorder, sepsis, Low platelet count.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Otorhinolaryngeology Departement, Faculty of Medicine , Assuit Univerisity

Asyut, Assuit, 71515, Egypt

Location

MeSH Terms

Conditions

Hearing Loss, Sudden; Hearing Loss, Sensorineural; Hearing Loss

Interventions

Anesthesia, Local; Injection, Intratympanic

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Mahmoud H Ali, MBBS

CONTACT

201062805374; mahmoud.nwawa@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor at Otolaryngology Departement, Principal Investigator

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: March 27, 2023
• Study Start: June 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: February 1, 2024
• Last Updated: April 19, 2023

Record last verified: 2023-04

Locations

EG (1)