NCT03812120

Brief Summary

The investigators want to demonstrate in a prospective, randomized trial including 350 patients undergoing cranial surgery that the use of L-PRF is non-inferior to classical fibrin sealants.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

December 1, 2018

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 22, 2019

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

January 22, 2019

Status Verified

January 1, 2019

Enrollment Period

4.1 years

First QC Date

December 13, 2018

Last Update Submit

January 18, 2019

Conditions

Cranial Sutures; Closure

Keywords

L-PRFCSF leakagefibrin sealants

Outcome Measures

Primary Outcomes (1)

  • Success rate

    The success rate is considered a thigh closure of the dura in both groups, which means no CSF leakage. This success rate was estimated at 95% in both techniques.

    4 years

Secondary Outcomes (2)

  • Cost effectiveness evaluation

    4 years

  • Complications

    4 years

Study Arms (2)

Classical Treatment

PLACEBO COMPARATOR

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

Procedure: Dural closure with classical fibrin sealants

L-PRF

ACTIVE COMPARATOR

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

Procedure: Dural closure with L-PRF

Interventions

Dural closure with L-PRFPROCEDURE

Evaluation of the safety and effectiveness of autologous blood-derived products (L-PRF) as an adjunct for dural repair

L-PRF
Dural closure with classical fibrin sealantsPROCEDURE

Evaluation of the safety and effectiveness of classical fibrin sealants as an adjunct for dural repair

Classical Treatment

Eligibility Criteria

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

You may qualify if:

  • Patients undergoing cranial neurosurgery whereby the dura is intentionally opened (supratentorial and infratentorial approach)
  • Age ≥ 18 years
  • Written informed consent
  • Willing to comply with the study schedule

You may not qualify if:

  • Participation in another clinical trial with study drugs or devices
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tom Theys

Leuven, 3000, Belgium

RECRUITING

Related Publications (2)

  • Coucke B, De Vleeschouwer S, van Loon J, Van Calenbergh F, Van Hoylandt A, Van Gerven L, Theys T. Leukocyte- and platelet-rich fibrin in cranial surgery: a single-blinded, prospective, randomized controlled noninferiority trial. J Neurosurg. 2024 Feb 23;141(2):500-508. doi: 10.3171/2023.12.JNS232125. Print 2024 Aug 1.

    PMID: 38394657DERIVED

  • Coucke B, Van Hoylandt A, van Loon J, Van Calenbergh F, Van Gerven L, Theys T. Leukocyte- and platelet-rich fibrin in cranial surgery: study protocol for a prospective, parallel-group, single-blinded randomized controlled non-inferiority trial 1. Trials. 2023 Mar 23;24(1):219. doi: 10.1186/s13063-023-07252-w.

    PMID: 36959672DERIVED

MeSH Terms

Conditions

Cerebrospinal Fluid Rhinorrhea

Condition Hierarchy (Ancestors)

Cerebrospinal Fluid LeakNeurologic ManifestationsNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemSigns and SymptomsPathological Conditions, Signs and SymptomsRhinorrheaSigns and Symptoms, RespiratoryWounds and Injuries

Study Officials

  • Tom Theys, Prof

    UZ Leuven

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tom Theys, Prof

CONTACT

003216344290tom.theys@uzleuven.be

Anais Van Hoylandt, Sc

CONTACT

003216342012anais.vanhoylands@uzleuven.be

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
Professor, Dr

Study Record Dates

First Submitted

December 13, 2018

First Posted

January 22, 2019

Study Start

December 1, 2018

Primary Completion

December 31, 2022

Study Completion

December 31, 2023

Last Updated

January 22, 2019

Record last verified: 2019-01

Locations

BE(1)