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L-PRF in Cranial Surgery

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ClinicalTrials.gov Identifier: NCT03812120
Recruitment Status : Recruiting
First Posted : January 22, 2019
Last Update Posted : January 22, 2019
Sponsor:
Information provided by (Responsible Party):
Tom Theys, Universitaire Ziekenhuizen Leuven

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cranial Sutures; Closure Procedure: Dural closure with L-PRF Procedure: Dural closure with classical fibrin sealants Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized controlled clinical trial
Masking: Single (Participant)
Masking Description: Participants stay masked during the trial, care provider and investigators are unblinded at the surgical procedure and from thereon.
Primary Purpose: Prevention
Official Title: L-PRF in Cranial Surgery: a Prospective, Randomized Trial
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Classical Treatment
In this arm, dural closure will be performed with the classical fibrine sealants.
 Procedure: Dural closure with classical fibrin sealants
Evaluation of the safety and effectiveness of classical fibrin sealants as an adjunct for dural repair
Active Comparator: L-PRF
In this arm, dural closure will be performed with the autologous L-PRF
 Procedure: Dural closure with L-PRF
Evaluation of the safety and effectiveness of autologous blood-derived products (L-PRF) as an adjunct for dural repair


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Cost effectiveness evaluation [ Time Frame: 4 years ]
    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.

  2. Complications [ Time Frame: 4 years ]
    Analysis of perioperative and postoperative complications, in particular surgical-site infection, treatment-site bleeding and CSF leakage.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Participation in another clinical trial with study drugs or devices
  • Pregnancy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03812120


Contacts
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Contact: Tom Theys, Prof 003216344290 ext 003216344290 tom.theys@uzleuven.be
Contact: Anais Van Hoylandt, Sc 003216342012 ext 003216342012 anais.vanhoylands@uzleuven.be

Locations
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Belgium
Tom Theys Recruiting
Leuven, Belgium, 3000
Contact: Tom Theys, Prof    003216344290 ext 003216344290    tom.theys@uzleuven.be   
Contact: Anais Van Hoylandt    003216342012 ext 003216342012    anais.vanhoylandt@uzleuven.be   
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: Tom Theys, Prof UZ Leuven
More Information
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Responsible Party: Tom Theys, Professor, Dr, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT03812120    
Other Study ID Numbers: s61460
First Posted: January 22, 2019    Key Record Dates
Last Update Posted: January 22, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tom Theys, Universitaire Ziekenhuizen Leuven:
L-PRF
CSF leakage
fibrin sealants
Additional relevant MeSH terms:
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Fibrin Tissue Adhesive
Hemostatics
Coagulants