MedTrace Logo

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

NCT05786378 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2023-04-19

No results posted yet for this study

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

Interventions

BIOLOGICAL

Platelet Rich Plasma

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.

DRUG

local anesthesia in external auditory canal

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

PROCEDURE

Intratympanic Injection

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

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2024-01-31
Completion
2024-02-29

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05786378 on ClinicalTrials.gov