Assessment of The Efficacy of Intratympanic Platelet Rich Plasma for Treatment of Sensorineural Hearing Loss.
NCT ID: NCT05786378
Last Updated: 2023-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
23 participants
INTERVENTIONAL
2023-06-01
2024-02-29
Brief Summary
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Detailed Description
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Sensorineural hearing loss is a challenge to physicians, as it progresses with age and causes significant reductions in quality of life and there are no treatments to reverse its effects, other than sound amplification with the use of hearing aids or direct auditory nerve stimulation via cochlear implantation.
Platelet-rich Plasma (PRP) Therapy is a cutting-edge procedure that is revolutionizing the hearing loss and deafness. Intratympanic instillation of Platelet-rich Plasma (PRP) does wonder to the hair cells of inner ear, thus improving the hearing.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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platlet rich plasma
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.
local anesthesia in external auditory canal
local anesthesia cream (lidocaine cream) will be applied in external auditory canal for 15 minutes
Intratympanic Injection
0.5-1 ml of PRP will be injected in middle ear cavity in round window niche Using microscope or endoscope.
Interventions
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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.
local anesthesia in external auditory canal
local anesthesia cream (lidocaine cream) will be applied in external auditory canal for 15 minutes
Intratympanic Injection
0.5-1 ml of PRP will be injected in middle ear cavity in round window niche Using microscope or endoscope.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. patients has absent cochlea in CT or MRI
3. patients has Cancer,Chronic liver disease, Hemodynamic instability,Hypofibrinogenemia, Platelet dysfunction syndromes, Systemic disorder, sepsis, Low platelet count.
5 Years
70 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Mahmoud Hassan Ali
Resident doctor at Otolaryngology Departement, Principal Investigator
Locations
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Otorhinolaryngeology Departement, Faculty of Medicine , Assuit Univerisity
Asyut, Assuit, Egypt
Countries
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Central Contacts
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Other Identifiers
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Intratympanic PRP
Identifier Type: -
Identifier Source: org_study_id
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