<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03812120</url>
  </required_header>
  <id_info>
    <org_study_id>s61460</org_study_id>
    <nct_id>NCT03812120</nct_id>
  </id_info>
  <brief_title>L-PRF in Cranial Surgery</brief_title>
  <official_title>L-PRF in Cranial Surgery: a Prospective, Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators want to demonstrate in a prospective, randomized trial including 350&#xD;
      patients undergoing cranial surgery that the use of L-PRF is non-inferior to classical fibrin&#xD;
      sealants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators want to demonstrate in a prospective, randomized trial including 350&#xD;
      patients undergoing cranial surgery that the use of L-PRF is non-inferior to classical fibrin&#xD;
      sealants.&#xD;
&#xD;
      Approximately 350 patients undergoing cranial surgery will be enrolled in this randomized,&#xD;
      controlled, single-blinded monocenter study to evaluate the safety and effectiveness of&#xD;
      autologous blood-derived products (L-PRF and fibrinogen) compared to the fibrin sealants as&#xD;
      an adjunct for dural repair (= primary objective).&#xD;
&#xD;
      The investigators will also evaluate if the use of L-PRF obviates the need for the use of&#xD;
      other autologous grafts (e.g. muscle/fat), commercial collagen-based products (e.g. Tachosil)&#xD;
      or articifial dura (=secondary objective).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>randomized controlled clinical trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Participants stay masked during the trial, care provider and investigators are unblinded at the surgical procedure and from thereon.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Success rate</measure>
    <time_frame>4 years</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cost effectiveness evaluation</measure>
    <time_frame>4 years</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>4 years</time_frame>
    <description>Analysis of perioperative and postoperative complications, in particular surgical-site infection, treatment-site bleeding and CSF leakage.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">350</enrollment>
  <condition>Cranial Sutures; Closure</condition>
  <arm_group>
    <arm_group_label>Classical Treatment</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>In this arm, dural closure will be performed with the classical fibrine sealants.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>L-PRF</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In this arm, dural closure will be performed with the autologous L-PRF</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Dural closure with L-PRF</intervention_name>
    <description>Evaluation of the safety and effectiveness of autologous blood-derived products (L-PRF) as an adjunct for dural repair</description>
    <arm_group_label>L-PRF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Dural closure with classical fibrin sealants</intervention_name>
    <description>Evaluation of the safety and effectiveness of classical fibrin sealants as an adjunct for dural repair</description>
    <arm_group_label>Classical Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing cranial neurosurgery whereby the dura is intentionally opened&#xD;
             (supratentorial and infratentorial approach)&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  Willing to comply with the study schedule&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participation in another clinical trial with study drugs or devices&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tom Theys, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>UZ Leuven</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tom Theys, Prof</last_name>
    <phone>003216344290</phone>
    <phone_ext>003216344290</phone_ext>
    <email>tom.theys@uzleuven.be</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Anais Van Hoylandt, Sc</last_name>
    <phone>003216342012</phone>
    <phone_ext>003216342012</phone_ext>
    <email>anais.vanhoylands@uzleuven.be</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Tom Theys</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tom Theys, Prof</last_name>
      <phone>003216344290</phone>
      <phone_ext>003216344290</phone_ext>
      <email>tom.theys@uzleuven.be</email>
    </contact>
    <contact_backup>
      <last_name>Anais Van Hoylandt</last_name>
      <phone>003216342012</phone>
      <phone_ext>003216342012</phone_ext>
      <email>anais.vanhoylandt@uzleuven.be</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>January 18, 2019</last_update_submitted>
  <last_update_submitted_qc>January 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universitaire Ziekenhuizen KU Leuven</investigator_affiliation>
    <investigator_full_name>Tom Theys</investigator_full_name>
    <investigator_title>Professor, Dr</investigator_title>
  </responsible_party>
  <keyword>L-PRF</keyword>
  <keyword>CSF leakage</keyword>
  <keyword>fibrin sealants</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fibrin Tissue Adhesive</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03812120
org study id: s61460
nct id: NCT03812120
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: randomized controlled clinical trial
primary purpose: Prevention
masking: Single (Participant)
masking description: Participants stay masked during the trial, care provider and investigators are unblinded at the surgical procedure and from thereon.
measure: Success rate
time frame: 4 years
description: 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.
measure: Cost effectiveness evaluation
time frame: 4 years
description: 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.
measure: Complications
time frame: 4 years
description: Analysis of perioperative and postoperative complications, in particular surgical-site infection, treatment-site bleeding and CSF leakage.
arm group label: Classical Treatment
arm group type: Placebo Comparator
description: In this arm, dural closure will be performed with the classical fibrine sealants.
arm group label: L-PRF
arm group type: Active Comparator
description: In this arm, dural closure will be performed with the autologous L-PRF
intervention type: Procedure
intervention name: Dural closure with L-PRF
description: Evaluation of the safety and effectiveness of autologous blood-derived products (L-PRF) as an adjunct for dural repair
arm group label: L-PRF
intervention type: Procedure
intervention name: Dural closure with classical fibrin sealants
description: Evaluation of the safety and effectiveness of classical fibrin sealants as an adjunct for dural repair
arm group label: Classical Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tom Theys, Prof
role: Principal Investigator
affiliation: UZ Leuven
last name: Tom Theys, Prof
phone: 003216344290
phone ext: 003216344290
email: tom.theys@uzleuven.be
last name: Anais Van Hoylandt, Sc
phone: 003216342012
phone ext: 003216342012
email: anais.vanhoylands@uzleuven.be
facility: 
status: Recruiting
contact: 
contact backup: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Universitaire Ziekenhuizen KU Leuven
investigator full name: Tom Theys
investigator title: Professor, Dr
mesh term: Fibrin Tissue Adhesive