Cranial Sutures; ClosureNCT03910374
Role of Leukocyte- and Platelet-Rich Fibrin Membranes in Endoscopic Endonasal Skull Base Reconstruction
A study testing Dural closure in people with Cranial Sutures; Closure, run by Universitaire Ziekenhuizen KU Leuven at 3 sites in 2 countries.
Trial summary
Prospective investigation of the effectivity of L-PRF membranes for skull base reconstruction after endoscopic endonasal skull base surgery (transsphenoidal) versus classical closure techniques. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cranial Sutures; Closure
- What is being tested?
- Dural closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Nov 2018to 28 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with lesions of the sellar/parasellar region
- Age > 18 and < 70 years
- Written informed consent
- Willingness to adhere to visit schedules
Who cannot join
- 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)
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
About this study
Prospective investigation of the effectivity of L-PRF membranes for skull base reconstruction after endoscopic endonasal skull base surgery (transsphenoidal) versus classical closure techniques.
Read the detailed description
The investigators want to demonstrate in a prospective, randomized trial including 220 patients undergoing endoscopic endonasal skull base surgery that the use of L-PRF is non-inferior to classical fibrin sealants.
Approximately 220 patients undergoing cranial surgery will be enrolled in this randomized, controlled, single-blinded multicenter study to evaluate the safety and effectiveness of autologous blood-derived products (L-PRF and fibrinogen) compared to the fibrin sealants as an adjunct for dural repair.
- Conditions
- Cranial Sutures; Closure
- Being tested
- Dural closure
- Keywords
- L-PRF, fibrin sealants, endoscopic endonasal skull base reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dural closureProcedure or surgery
Evaluation of the safety and effectiveness of autologous blood-derived products (L-PRF and fibrinogen) compared to the fibrin sealants as an adjunct for dural repair
| Study group | Role | What they receive |
|---|---|---|
| Classical Treatment | Placebo comparator | In this arm, dural closure will be performed with the classical fibrine sealants. Receives: Procedure: Dural closure |
| L-PRF | Active comparator | In this arm, dural closure will be performed with the autologous L-PRF Receives: Procedure: Dural closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the prevalence of CSF-leaks after L-PRF closure and after the classical closure techniques for sellar defects to demonstrate non-inferiority
The primary aim of this study is identifying the role of L-PRF in the endoscopic endonasal closure of skull base defects. More specific, we want to demonstrate in a prospective, randomized trial that the use of L-PRF is non-inferior to classical closure techniques regarding prevalence of CSF-leaks The number of patients with a CSF-leak will be compared between both treatment groups.
Measured: 4 years
Cost-effectiveness evaluation based on the effectiveness and the costs of L-PRF versus the current golden standard (Tachosil and Tisseel).
Cost-effectiveness evaluation: compare the costs and the effectiveness of L-PRF versus commercial fibrin sealants.
Measured: 4 years
Secondary outcomes (8)
To identify potential risk for closure-failures based on the size of the lesion
The potential risk for closure-failure (evaluated by the prevalence of CSF-leaks) based size of lesion ( evaluated by Wilson-Hardy classification) will be measured.
Measured: 4 years
To evaluate if the pathology is a potential risk factor for closure-failures
The potential risk for closure-failure (evaluated by the prevalence of CSF-leaks) based on the pathology will be evaluated.
Measured: 4 years
To evaluate if the age of the patient is a potential risk factor for closure-failures
The potential risk for closure-failure (evaluated by the prevalence of CSF-leaks) based on the age of the patients will be measured.
Measured: 4 years
Evaluate the effect of L-PRF versus the current golden standard (Tachosil and Tisseel) on post-operative symptoms based on a visual analogue scale
Rhinological symptoms as well as quality of life before and after surgery will be assessed using a visual analogue scale. The symptoms will be scored on a horizontal line of 10 cm, where 0 cm equals "no symptoms" and 10 cm equals "very severe symptoms".
Measured: 4 years
Evaluate the effect of L-PRF versus the current golden standard (Tachosil and Tisseel) on post-operative symptoms based on the SNOT-22
Rhinological symptoms as well as quality of life before and after surgery will be assessed using a SNOT-22. The symptoms will be scored between 0 and 5 where 0 equals "no symptoms" and 5 equals "very severe symptoms".
Measured: 4 years
Evaluate the effect of L-PRF versus the current golden standard (Tachosil and Tisseel) on post-operative symptoms based on the skull base questionnaire
Rhinological symptoms as well as quality of life before and after surgery will be assessed using the skull base questionnaire.
Measured: 4 years
Evaluate the effect of L-PRF versus the current golden standard (Tachosil and Tisseel) on post-operative symptoms based on the EQ-5D
Rhinological symptoms as well as quality of life before and after surgery will be assessed using the EQ-5D
Measured: 4 years
Evaluate the potential interference of the L-PRF membranes with post-operative imaging by comparing the tumor residue evaluation 3 months and 1 year after surgery
potential interference of the L-PRF membranes with post-operative imaging (MRI) will be evaluated. 3 months after surgery, when the L-PRF membrane is still visible, the MRI images will be evaluated to see if there is tumor residue present or not. After 1 year the presence of tumor residue will be reevaluated. The outcomes will be compared between both evaluation timepoints to asses if L-PRF has interference with the imaging.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start1 Nov 2018
- Primary completion1 Oct 2025
- Study completion28 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cranial Sutures; ClosureStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Van Gerven, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Laura Van Gerven, prof, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03910374
- Sponsor's protocol ID
- s61636
- Status last verified
- Apr 2026
- First submitted
- 20 Mar 2019
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Coucke B, Van Hoylandt A, Jorissen M, Meulemans J, Decramer T, van Loon J, Vander Poorten V, Theys T, Van Gerven L. Leukocyte- and platelet-rich fibrin in endoscopic endonasal skull base reconstruction: study protocol for a multicenter prospective, parallel-group, single-blinded randomized controlled non-inferiority trial. Trials. 2023 Jul 31;24(1):488. doi: 10.1186/s13063-023-07492-w.
PubMed 37525278
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Leukocyte- and Platelet-Rich Fibrin Membranes in Endoscopic Endonasal Skull Base Reconstruction
- ClinicalTrials.gov ID
- NCT03910374
- Acronym / sponsor ID
- s61636
- Conditions
- Cranial Sutures; Closure
- Keywords
- L-PRF, fibrin sealants, endoscopic endonasal skull base reconstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 28 Dec 2025 (actual)
- First posted
- 10 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective investigation of the effectivity of L-PRF membranes for skull base reconstruction after endoscopic endonasal skull base surgery (transsphenoidal) versus classical closure techniques.
Detailed description
The investigators want to demonstrate in a prospective, randomized trial including 220 patients undergoing endoscopic endonasal skull base surgery that the use of L-PRF is non-inferior to classical fibrin sealants.
Approximately 220 patients undergoing cranial surgery will be enrolled in this randomized, controlled, single-blinded multicenter study to evaluate the safety and effectiveness of autologous blood-derived products (L-PRF and fibrinogen) compared to the fibrin sealants as an adjunct for dural repair.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Classical Treatment | Placebo comparator | Procedure: Dural closureIn this arm, dural closure will be performed with the classical fibrine sealants. |
| L-PRF | Active comparator | Procedure: Dural closureIn this arm, dural closure will be performed with the autologous L-PRF |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with lesions of the sellar/parasellar region
- Age > 18 and < 70 years
- Written informed consent
- Willingness to adhere to visit schedules
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dural closureEvaluation of the safety and effectiveness of autologous blood-derived products (L-PRF and fibrinogen) compared to the fibrin sealants as an adjunct for dural repair | Procedure or surgery | Classical Treatment, L-PRF |
Primary outcome
To compare the prevalence of CSF-leaks after L-PRF closure and after the classical closure techniques for sellar defects to demonstrate non-inferiority
Time frame: 4 years
The primary aim of this study is identifying the role of L-PRF in the endoscopic endonasal closure of skull base defects. More specific, we want to demonstrate in a prospective, randomized trial that the use of L-PRF is non-inferior to classical closure techniques regarding prevalence of CSF-leaks The number of patients with a CSF-leak will be compared between both treatment groups.
Cost-effectiveness evaluation based on the effectiveness and the costs of L-PRF versus the current golden standard (Tachosil and Tisseel).
Time frame: 4 years
Cost-effectiveness evaluation: compare the costs and the effectiveness of L-PRF versus commercial fibrin sealants.
8 secondary outcomes
To identify potential risk for closure-failures based on the size of the lesion
Time frame: 4 years
To evaluate if the pathology is a potential risk factor for closure-failures
Time frame: 4 years
To evaluate if the age of the patient is a potential risk factor for closure-failures
Time frame: 4 years
Evaluate the effect of L-PRF versus the current golden standard (Tachosil and Tisseel) on post-operative symptoms based on a visual analogue scale
Time frame: 4 years
Evaluate the effect of L-PRF versus the current golden standard (Tachosil and Tisseel) on post-operative symptoms based on the SNOT-22
Time frame: 4 years
Evaluate the effect of L-PRF versus the current golden standard (Tachosil and Tisseel) on post-operative symptoms based on the skull base questionnaire
Time frame: 4 years
Evaluate the effect of L-PRF versus the current golden standard (Tachosil and Tisseel) on post-operative symptoms based on the EQ-5D
Time frame: 4 years
Evaluate the potential interference of the L-PRF membranes with post-operative imaging by comparing the tumor residue evaluation 3 months and 1 year after surgery
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Derived from this study: PubMed 37525278Coucke B, Van Hoylandt A, Jorissen M, Meulemans J, Decramer T, van Loon J, Vander Poorten V, Theys T, Van Gerven L. Leukocyte- and platelet-rich fibrin in endoscopic endonasal skull base reconstruction: study protocol for a multicenter prospective, parallel-group, single-blinded randomized controlled non-inferiority trial. Trials. 2023 Jul 31;24(1):488. doi: 10.1186/s13063-023-07492-w.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Van Gerven, prof principal investigator
UZ Leuven
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dural closure in people with Cranial Sutures; Closure, run by Universitaire Ziekenhuizen KU Leuven at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the prevalence of CSF-leaks after L-PRF closure and after the classical closure techniques for sellar defects to demonstrate non-inferiority (time frame: 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03910374, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.