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Two-site Blind Epidural Patch Versus Targeted Epidural Patch With Autologous Platelet-rich Plasma for Spontaneous Intracranial Hypotension: A Prospective, Assessor Blind, Randomized, Controlled, Noninferiority Trial
Spontaneous intracranial hypotension (SIH) is a condition characterized by refractory orthostatic headache, mostly due to loss of cerebrospinal fluid (CSF). Epidural patch with autologous platelet-rich plasma (PRP), which contains numerous growth factors and cytokines, has been reported as a successful alternative for whole blood in dura repair. However, there is no report regarding the best approach to use: targeted epidural PRP patch (TEPP) versus blind epidural PRP patch (BEPP). Preliminary work has suggested that both targeted and blind approaches are effective when using whole blood for epidural patch. Furthermore, two-site blind approach could be considered as a viable initial treatment regardless of the identification of the leak for conventional targeted approach. In this study, the investigators aimed to investigate the non-inferiority of two-site BEPP compared with TEPP for the treatment of refractory SIH cases failing in conservative therapy.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Start Date
December 20, 2025
Primary Completion Date
December 31, 2026
Completion Date
December 31, 2026
Last Updated
December 19, 2025
58
ESTIMATED participants
Targeted epidural PRP patch
PROCEDURE
Blind epidural PRP patch
PROCEDURE
Lead Sponsor
Beijing Tiantan Hospital
NCT06805591
NCT02261792
Data Source & Attribution
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