Cranial Sutures; ClosureNCT03812120
L-PRF in Cranial Surgery
A study testing Dural closure with L-PRF and Dural closure with classical fibrin sealants in people with Cranial Sutures; Closure, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cranial Sutures; Closure
- What is being tested?
- Dural closure with L-PRF and Dural closure with classical fibrin sealants
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Dec 2018to 31 Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participation in another clinical trial with study drugs or devices
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Tom Theys
Leuven, 3000
Tom Theys, Prof, 003216344290 ext. 003216344290, tom.theys@uzleuven.be
Anais Van Hoylandt, 003216342012 ext. 003216342012, anais.vanhoylandt@uzleuven.be
About this study
Official title: L-PRF in Cranial Surgery: a Prospective, Randomized Trial
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.
Read the detailed description
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.
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
- Cranial Sutures; Closure
- Being tested
- Dural closure with L-PRF, Dural closure with classical fibrin sealants
- Keywords
- L-PRF, CSF leakage, fibrin sealants
- Medical subject headings
- Cerebrospinal Fluid Rhinorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dural closure with L-PRFProcedure or surgery
Evaluation of the safety and effectiveness of autologous blood-derived products (L-PRF) as an adjunct for dural repair
Dural closure with classical fibrin sealantsProcedure or surgery
Evaluation of the safety and effectiveness of classical 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 with classical fibrin sealants |
| L-PRF | Active comparator | In this arm, dural closure will be performed with the autologous L-PRF Receives: Procedure: Dural closure with L-PRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 years
Secondary outcomes (2)
Cost effectiveness evaluation
A carefull registration of the used products (L-PRF versus commercial fibrin sealants), the quantity and the actual costs of these products will be noted during the operation procedure and will be analyzed.
Measured: 4 years
Complications
Analysis of perioperative and postoperative complications, in particular surgical-site infection, treatment-site bleeding and CSF leakage.
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 posted22 Jan 2019
- Study start1 Dec 2018
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tom Theys, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Tom Theys, Prof, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03812120
- Sponsor's protocol ID
- s61460
- Status last verified
- Jan 2019
- First submitted
- 13 Dec 2018
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38394657Coucke 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.
PubMed 36959672
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- L-PRF in Cranial Surgery: a Prospective, Randomized Trial
- ClinicalTrials.gov ID
- NCT03812120
- Acronym / sponsor ID
- s61460
- Conditions
- Cranial Sutures; Closure
- Keywords
- L-PRF, CSF leakage, fibrin sealants
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 22 Jan 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.
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.
Detailed description
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.
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).
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 closure with classical fibrin sealantsIn this arm, dural closure will be performed with the classical fibrine sealants. |
| L-PRF | Active comparator | Procedure: Dural closure with L-PRFIn this arm, dural closure will be performed with the autologous L-PRF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Participation in another clinical trial with study drugs or devices
- Pregnancy
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 closure with L-PRFEvaluation of the safety and effectiveness of autologous blood-derived products (L-PRF) as an adjunct for dural repair | Procedure or surgery | L-PRF |
| Dural closure with classical fibrin sealantsEvaluation of the safety and effectiveness of classical fibrin sealants as an adjunct for dural repair | Procedure or surgery | Classical Treatment |
Primary outcome
Success rate
Time frame: 4 years
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.
2 secondary outcomes
Cost effectiveness evaluation
Time frame: 4 years
Complications
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2019.
- Derived from this study: PubMed 38394657Coucke 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.
- Derived from this study: PubMed 36959672Coucke 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.
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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.
Tom Theys, Prof principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dural closure with L-PRF and Dural closure with classical fibrin sealants in people with Cranial Sutures; Closure, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 2 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: status not confirmed, as of the sponsor's last update on 22 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tom Theys, Prof (003216344290 ext. 003216344290, tom.theys@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate (time frame: 4 years). 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 NCT03812120, which also lists 2 linked publications.
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 22 Jan 2019.