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Clinical Trials/NCT07602556
NCT07602556Not yet recruitingNot Applicable

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

Beijing Tiantan Hospital0 sites218 target enrollmentStarted: May 1, 2026Last updated:
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Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
218
Study OverviewStudy DesignEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Informed consent to participate the research obtained from the patient
  • •Satisfies the criteria for SIH according to the International Classification of Headache Disorders.

Exclusion Criteria

  • •There was concern for other causes of intracranial hypotension, such as postdural puncture, postsurgical and post-traumatic CSF leaks
  • •Prior treatment with EBP at any time previously
  • •Any contraindication to epidural puncture, such as space-occupying intracranial or intraspinal lesions, spinal defect, suspected infection over the puncture site, bleeding disorder and current anticoagulation therapy
  • •History of drug and alcohol abuse, cognitive dysfunction, or mental illness
  • •Unable to cooperate with postoperative evaluation, treatment, rehabilitation, and follow-up visits

Investigators

Sponsor
Beijing Tiantan Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Fang Luo

Professor

Beijing Tiantan Hospital

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