Not Yet RecruitingNot Applicable

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

218 participantsStarted 2026-05

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The complete relief rate of patients with SIH

Timeframe: At 3 months after first epidural patch

Trial details

NCT IDNCT07602556

SponsorBeijing Tiantan Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12

View on ClinicalTrials.gov More Spontaneous Intracranial Hypotension trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.