NCT03910374

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2019

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 10, 2019

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2025

Completed
Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

6.9 years

First QC Date

March 20, 2019

Last Update Submit

April 30, 2026

Conditions

Cranial Sutures; Closure

Keywords

L-PRFfibrin sealantsendoscopic endonasal skull base reconstruction

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    4 years

Secondary Outcomes (8)

  • To identify potential risk for closure-failures based on the size of the lesion

    4 years

  • To evaluate if the pathology is a potential risk factor for closure-failures

    4 years

  • To evaluate if the age of the patient is a potential risk factor for closure-failures

    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

    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

    4 years

  • +3 more secondary outcomes

Study Arms (2)

Classical Treatment

PLACEBO COMPARATOR

In this arm, dural closure will be performed with the classical fibrine sealants.

Procedure: Dural closure

L-PRF

ACTIVE COMPARATOR

In this arm, dural closure will be performed with the autologous L-PRF

Procedure: Dural closure

Interventions

Dural closurePROCEDURE

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

Classical TreatmentL-PRF

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with lesions of the sellar/parasellar region
  • Age \> 18 and \< 70 years
  • Written informed consent
  • Willingness to adhere to visit schedules

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

AZ Sint-Jan

Bruges, 8000, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Fundació Clínic Per A La Recerca Biomèdica

Barcelona, 08036, Spain

Location

Related Publications (1)

  • 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.

    PMID: 37525278DERIVED

Study Officials

  • Laura Van Gerven, prof

    UZ Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants stay masked during the trial, care provider and investigators are unblinded at the surgical procedure and from thereon
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized controlled clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor, Doctor

Study Record Dates

First Submitted

March 20, 2019

First Posted

April 10, 2019

Study Start

November 1, 2018

Primary Completion

October 1, 2025

Study Completion

December 28, 2025

Last Updated

May 6, 2026

Record last verified: 2026-04

Locations

BE(2)ES(1)