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

NCT07283536 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2026-05-11

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Beijing Tiantan Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-20
Primary Completion
2026-12-31
Completion
2026-12-31

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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 NCT07283536 on ClinicalTrials.gov