Clinical Trial

Blind Versus Targeted Epidural Patch With Autologous Platelet-rich Plasma for Spontaneous Intracranial Hypotension

Withdrawn
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Why the trial stopped
Current literatures reported that MRM or non-dynamic CTM can not allow for adequate leak localization, so as not to guide targeted epidural patch. Leak detection requires dynamic CTM or DSA, which was not available for all our patients.
Summary
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-12-04; most recent amendment 2026-05-06.
Status change: Not Yet Recruiting → Withdrawn 2026-05-06
Trial Details
NCT Number NCT07283536
Lead Sponsor Beijing Tiantan Hospital
Conditions Spontaneous Intracranial Hypotension
Start Date 2025-12-20
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-11