NCT07283536

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spontaneous Intracranial Hypotension

Interventions

Type	Name	Description
PROCEDURE	Targeted epidural PRP patch	Each patient was subjected to either magnetic resonance myelography (MRM) or/and computed tomography myelography (CTM) to detect the location of CSF leaking. PRP was prepared with the 2-stage centrifugation method and a standard epidural puncture was conducted at the definitive CSF leak locations under the guidance of CT. A predetermined volume of PRP (no more than 10 mL) was titrated slowly into the epidural space for each level. A strict bed stay for 48 h was prescribed in supine position postoperatively.
PROCEDURE	Blind epidural PRP patch	PRP was prepared with the 2-stage centrifugation method and the investigators chose two separate sites for epidural access, the C7-T1 and L4-5 levels. A standard epidural puncture was conducted under the guidance of CT. A predetermined volume of PRP (no more than 10 mL) was titrated slowly into the epidural space for each level. A strict bed stay for 48 h was prescribed in supine position postoperatively.

Timeline

• Start date: 2025-12-20
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-12-16
• Last updated: 2025-12-19