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NOT YET RECRUITING
NCT07602556
NA

Autologous Platelet-rich Plasma Versus Whole Blood for Epidural Patch in Spontaneous Intracranial Hypotension

Sponsor: Beijing Tiantan Hospital

View on ClinicalTrials.gov

Summary

Spontaneous intracranial hypotension (SIH) is a condition characterized by refractory orthostatic headache, mostly due to leaks of cerebrospinal fluid (CSF). Epidural patch with autologous platelet-rich plasma (PRP), which contains numerous growth factors and cytokines, has been reported as a new and promising alternative for current standard whole blood patching. However, there is no study comparing the efficacy and safety of the two approaches. In this study, we aimed to provide data concerning the outcomes of PRP patching versus conventional whole blood patching for treatment of refractory SIH cases failing in conservative therapy.

Official title: Autologous Platelet-rich Plasma Versus Whole Blood for Epidural Patch in Spontaneous Intracranial Hypotension: A Multi-center, Prospective, Randomized Controlled Trial

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

218

Start Date

2026-05

Completion Date

2029-03

Last Updated

2026-05-27

Healthy Volunteers

No

Interventions

PROCEDURE

PRP Patch group

Autologous PRP was prepared with the 2-stage centrifugation method and mixed with iohexol contrast. We chose two separate sites for epidural access. A standard epidural puncture was conducted under the guidance of CT. The PRP mixture was titrated slowly into the epidural space and must be stopped immediately to patient's perception of backache or irradiating pain. A strict bed stay for 48 h was prescribed in supine position postoperatively.

PROCEDURE

Whole Blood Patch Group

Autologous whole blood was prepared and mixed with iohexol contrast. We chose two separate sites for epidural access. A standard epidural puncture was conducted under the guidance of CT. The whole blood mixture was titrated slowly into the epidural space and must be stopped immediately to patient's perception of backache or irradiating pain. A strict bed stay for 48 h was prescribed in supine position postoperatively.