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Could your own blood seal a brain leak better than glue?

NCT ID NCT03910374

Disease control Sponsor: Universitaire Ziekenhuizen KU Leuven Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether membranes made from a patient's own blood (L-PRF) can seal the skull base after sinus surgery as well as standard fibrin glues. 220 adults with sellar lesions were randomly assigned to receive either L-PRF or commercial sealants. The main goal was to compare rates of cerebrospinal fluid (CSF) leaks and costs.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Leukocyte- and platelet-rich fibrin (L-PRF) membranes
What this could lead to
If successful, this could offer a safer, cheaper way to repair skull base defects using the patient's own blood, reducing reliance on commercial sealants.
What could go wrong
This is a completed non-inferiority trial; results may show L-PRF is not as effective as standard methods, and individual healing responses vary.

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

220 people

The number who actually took part.

Started

Nov 2018

Finished

Dec 2025

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

18 to 70 years

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: * Patients with lesions of the sellar/parasellar region * Age \> 18 and \< 70 years * Written informed consent * Willingness to adhere to visit schedules Exclusion Criteria: * Age \< 18 and \> 70 years * Any underlying rhinological condition like nasal polyps, which may interfere with the obtained results * Any disorder which might compromise the ability of a patient to give truly informed consent for participation in this study * Enrollment in other investigational drug trial(s)

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Conditions

The condition(s) this trial relates to.

craniosynostosis

As listed by the trial registrant

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

Cranial sutures; closure

Contacts and locations

Locations

  • AZ Sint-Jan

    Bruges, 8000, Belgium

  • Fundació Clínic Per A La Recerca Biomèdica

    Barcelona, 08036, Spain

  • UZ Leuven

    Leuven, 3000, Belgium