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Blood patch showdown: could Platelet-Rich plasma beat whole blood for rare headache condition?

NCT ID NCT07602556

Disease control Sponsor: Beijing Tiantan Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a patch made from a patient's own platelet-rich plasma works better than a standard whole blood patch for treating spontaneous intracranial hypotension, a condition causing severe headaches from spinal fluid leaks. About 218 adults who haven't improved with conservative care will be randomly assigned to one of the two patch types. The main goal is to see which approach provides more complete headache relief after the procedure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 218 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

intracranial hypotension spontaneous intracranial hypotension

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Spontaneous intracranial hypotension

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.