Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
350 participants
INTERVENTIONAL
2018-12-01
2023-12-31
Brief Summary
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Detailed Description
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Approximately 350 patients undergoing cranial surgery will be enrolled in this randomized, controlled, single-blinded monocenter 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 (= primary objective).
The investigators will also evaluate if the use of L-PRF obviates the need for the use of other autologous grafts (e.g. muscle/fat), commercial collagen-based products (e.g. Tachosil) or articifial dura (=secondary objective).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Classical Treatment
In this arm, dural closure will be performed with the classical fibrine sealants.
Dural closure with classical fibrin sealants
Evaluation of the safety and effectiveness of classical fibrin sealants as an adjunct for dural repair
L-PRF
In this arm, dural closure will be performed with the autologous L-PRF
Dural closure with L-PRF
Evaluation of the safety and effectiveness of autologous blood-derived products (L-PRF) as an adjunct for dural repair
Interventions
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Dural closure with L-PRF
Evaluation of the safety and effectiveness of autologous blood-derived products (L-PRF) as an adjunct for dural repair
Dural closure with classical fibrin sealants
Evaluation of the safety and effectiveness of classical fibrin sealants as an adjunct for dural repair
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years
* Written informed consent
* Willing to comply with the study schedule
Exclusion Criteria
* Pregnancy
18 Years
ALL
No
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Tom Theys
Professor, Dr
Principal Investigators
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Tom Theys, Prof
Role: PRINCIPAL_INVESTIGATOR
UZ Leuven
Locations
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Tom Theys
Leuven, , Belgium
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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s61460
Identifier Type: -
Identifier Source: org_study_id
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