<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/NCT04485494</url>
  </required_header>
  <id_info>
    <org_study_id>CRSU-016</org_study_id>
    <nct_id>NCT04485494</nct_id>
  </id_info>
  <brief_title>Blood-based Biomarkers for the Prognosis of Sports Related Concussion</brief_title>
  <official_title>A Blood Biomarker Study With Clinical Correlation for the Diagnosis and Prognosis of Sports Related Concussion in Elite Rugby</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Limerick</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Limerick</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 diagnosis of sports related concussion still relies heavily on a subjective assessment.&#xD;
      In this study the investigators want to assess the prognostic value of blood-based biomarkers&#xD;
      with recovery from concussive episodes over specific time points post-injury. Our research&#xD;
      aims to (1) assess that the World Rugby's head injury assessment (HIA) can identify that a&#xD;
      concussion has taken place by measuring specific biomarkers in the blood and (2) to track&#xD;
      these biomarkers over time post-injury as a means to assess player health.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The diagnosis and prognosis of sports related concussion (SRC) still rely on a subjective&#xD;
      assessment based on the SCAT5 procedure. Our knowledge of how sports related concussion&#xD;
      effects an athlete over time is limited as all patients may have different recovery times&#xD;
      from concussion. Our research aims to quantitatively confirm that the head injury assessment&#xD;
      has predicted a concussion against clinical assessment (SCAT5) and that a return to play&#xD;
      protocol allows sufficient recovery time for an athlete.&#xD;
&#xD;
      Numerous novel areas of diagnosis are currently under investigation including protein-based&#xD;
      biomarkers. In the context of SRC, these protein biomarkers typically consist of neurological&#xD;
      proteins normally confined to the central nervous system or associated with neurological cell&#xD;
      damage. Recent studies have compared biomarker levels at different time points post-diagnosis&#xD;
      or investigated the relationship between early biomarker levels and return to play (RTP)&#xD;
      times. However, the use of these biomarkers for actively evaluating player recovery following&#xD;
      SRC has yet to be fully investigated. In this study, the investigators will measure&#xD;
      biomarkers levels across multiple time points post-SRC to assess the value of these&#xD;
      biomarkers to monitor player recovery. This is of significant for minimising premature RTP&#xD;
      and, ultimately, aiming to reduce the chronic long-term effects associated with SRC.&#xD;
&#xD;
      To truly identify a biomarker specific to concussion this study will need to, first, analyse&#xD;
      the bloods of concussion patients and compare to the clinical assessment of the head injury&#xD;
      assessment (HIA), and, second, measure their levels over time to indicate recovery that may&#xD;
      aid in a safe return to play.&#xD;
&#xD;
      Briefly, blood samples are taken from consented participants at the start of pre-season to&#xD;
      act as a baseline. Once one of these participants enters the HIA process their bloods are&#xD;
      taken post-injury, 6 days after injury and 13 days after injury. Next, the biomarkers are&#xD;
      measured in the blood samples at each time point to examine if there is any increase/decrease&#xD;
      in their levels.&#xD;
&#xD;
      Study Design:&#xD;
&#xD;
      A prospective cohort study with an uninjured and exercise free control groups.&#xD;
&#xD;
      Population:&#xD;
&#xD;
      All participants are professional rugby players from one professional rugby club were&#xD;
      initially invited to participate. Initial contact was made to the Irish Rugby Football Union&#xD;
      (IRFU) chief medical officer for permission to run the study over a three-year period. Next&#xD;
      permission to run this cohort study was sought from the head coach and medical staff of the&#xD;
      professional rugby team.&#xD;
&#xD;
      Baseline Questionnaire:&#xD;
&#xD;
      Participants will complete a baseline questionnaire that includes questions regarding their&#xD;
      concussion history including symptoms associated with, length of, and outcome of previous&#xD;
      injuries. The questionnaire was developed in line with previous sports-based concussion&#xD;
      studies used for ice hockey and Australian football&#xD;
&#xD;
      Timeframes&#xD;
&#xD;
      As part of this study, any participant that enters the standard HIA process will undergo a&#xD;
      HIA, a neuropsychometric assessment, and blood sampling at the following time points:&#xD;
&#xD;
        1. Within 72 hours of injury,&#xD;
&#xD;
        2. 6 days post-injury (± 1 day); this aligns with the minimum graduated return to play&#xD;
           (GRTP) protocol for a professional rugby player, no player will return to play before 6&#xD;
           days,&#xD;
&#xD;
        3. 13 days post-injury (± 1 day) to examine if biomarkers are still present despite the&#xD;
           results the HIA and the neuropsychometric assessment.&#xD;
&#xD;
      Serial HIA Participants that suffer a suspected SRC will complete the HIA protocol at the&#xD;
      time points outlined above. This is a form of the SCAT5 which has been modified for&#xD;
      professional rugby and GRTP. This assessment will be carried out by the medical officer of&#xD;
      the professional rugby club.&#xD;
&#xD;
      Neuropsychometric Assessment During preseason players complete a baseline computed based&#xD;
      neuropsychometric assessment - ImPACT. This assessment measures different cognitive domains&#xD;
      including visual memory, visual processing speed, reaction times and working memory as well&#xD;
      as attention. Post injury players are re-assessed once symptom free to determine recovery fo&#xD;
      these domains and to assess for any persistent patterns of deficit. This assessment forms a&#xD;
      part of the overall concussion assessment and management plan.&#xD;
&#xD;
      Blood Draw:&#xD;
&#xD;
      The medical officer and/or clinical nurse will take the samples of blood at the timepoints&#xD;
      outlined above. The medical officer or nurse usually takes the blood sample from the&#xD;
      antecubital vein in the arm.&#xD;
&#xD;
      Bloods are collected by a member of the study team from the medical officer or nurse after&#xD;
      the participant has left to ensure confidentiality. Three types of sample vials are used to&#xD;
      ensure different types of biochemical techniques can be used and certain markers can be&#xD;
      examined; serum, plasma and whole blood. Whole blood samples are immediately aliquoted in 2&#xD;
      mL cryo-vials of 1- 1.5 mL each. For serum samples the blood is allowed to clot within the&#xD;
      tube for up to 30 minutes. For both serum and plasma vials, they are centrifuged at 2,000 xg&#xD;
      for 10 minutes at 4 °C. The serum and plasma are carefully pipetted and aliquoted into&#xD;
      respective 2 mL cryo-vials with no less than 400 µL in each cryo-vial. All aliquoted&#xD;
      cryo-vials are placed into storage boxes within a -80 °C freezer for long-term storage. Each&#xD;
      aliquot can be removed to probe for different biomarkers without multiple freeze-thaw cycles&#xD;
      on the core sample.&#xD;
&#xD;
      Blood Biomarkers The blood-based biomarkers that can be analysed using standard biochemical&#xD;
      techniques for a targeted and hypothesis-based procedures using ELISA kits or Luminex&#xD;
      multiplex assays. Serum and plasma samples allows for a multitude of targets to be analysed&#xD;
      which may be found in either serum or plasma. For this type of analysis common targets can be&#xD;
      used to compare across the timepoints. The biomarkers under investigation can be but not&#xD;
      limited to s100β, ubiquitin carboxyl-terminal hydrolase isoenzyme L1, glial fibrillar acidic&#xD;
      protein and total, Tau protein and Brain-derived neurotrophic factor.&#xD;
&#xD;
      Outcomes Each participant that is believed to have a SRC will enter the HIA process. These&#xD;
      participants will have clinical assessments conducted at pre-defined time points, in line&#xD;
      with the World Rugby guidelines. Blood samples will also be acquired at these time points to&#xD;
      quantify the levels of blood-based biomarkers. Biomarker levels will be correlated to the&#xD;
      results of the HIA and neuropsychometric assessments. This will facilitate preliminary&#xD;
      investigation of the correlation between clinical assessments and biomarker levels to&#xD;
      determine if the biomarkers can be used to objectively assess SRC recovery&#xD;
&#xD;
      Investigations:&#xD;
&#xD;
      A collaborative relationship exists between this research group and the University of&#xD;
      Limericks (UL) Clinical Research Support Unit (CRSU). The CRSU provided advice and supported&#xD;
      the delivery of this research project to the highest standard of research and clinical&#xD;
      governance in accordance with the requirements of ICH Good Clinical Practice (ICH-GCP)&#xD;
      Guidelines and all applicable regulatory requirements. The participant contact element of&#xD;
      this study was conducted by adhering to the CRSU's Quality Management System (QMS).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2018</start_date>
  <completion_date type="Actual">May 1, 2023</completion_date>
  <primary_completion_date type="Actual">May 1, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical Diagnosis</measure>
    <time_frame>Bloods to be taken within 72 hours of injury</time_frame>
    <description>Measure the levels of blood biomarkers in rugby players that have experienced a concussion, confirmed via HIA and neuropsychometric assessment, to assess the utility of these biomarkers for concussion diagnosis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Recovery</measure>
    <time_frame>Bloods to be taken within 6 and 13 days post-injury</time_frame>
    <description>Track the levels of the blood biomarkers over time, post-injury to determine if biomarker levels correlate with clinical recovery.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">45</enrollment>
  <condition>Traumatic Brain Injury</condition>
  <condition>Sports Injury</condition>
  <condition>Concussion, Mild</condition>
  <arm_group>
    <arm_group_label>Professional Rugby Athletes</arm_group_label>
    <description>These are the cohort of players that consent to the study and have a preseason baseline blood sample taken. If the participant from this cohort then receives a concussion they are assessed by the World Rugby's Head Injury Assessment (HIA) and then enter into the return to play (RTP) protocol which means they cannot play a competitive game for 6 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Biochemical Analysis of Blood Biomarkers</intervention_name>
    <description>Using established biochemical techniques, the bloods will be probed for specific biomarkers s100B, UCH-L1, GFAP, and BDNF. The techniques include individual ELISA kits for each biomarker mentioned and Luminex multiplate assay which will probe for all biomarkers in one plate. Ultimately, these techniques will be able to measure the level of these biomarkers in the blood relative to the participants baseline reading.</description>
    <arm_group_label>Professional Rugby Athletes</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples at each time point are taken. Approximately, 30 mL of blood are drawn across 3&#xD;
      vials to allow for collection of whole blood, serum and plasma from the same participant at&#xD;
      each time point.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All participants are professional rugby players from a professional rugby club were have&#xD;
        been invited to participate. Initial contact was made to the Irish Rugby Football Union&#xD;
        (IRFU) chief medical officer for permission to run the study over a three-year period. Next&#xD;
        permission to run this cohort study was sought from the head coach and medical staff of the&#xD;
        professional rugby team.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Participants are eligible to participate if they&#xD;
&#xD;
          1. are part of the professional rugby team's senior squad or the academy;&#xD;
&#xD;
          2. aged over 18;&#xD;
&#xD;
          3. consent to the study over the whole season.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Participants are excluded if they&#xD;
&#xD;
          1. are unable to attend the preseason baseline draw;&#xD;
&#xD;
          2. unable to give informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jamie Kearns, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Munster Rugby</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Munster Rugby</name>
      <address>
        <city>Limerick</city>
        <state>Munster</state>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ireland</country>
  </location_countries>
  <reference>
    <citation>Fuller CW, Taylor A, Kemp SP, Raftery M. Rugby World Cup 2015: World Rugby injury surveillance study. Br J Sports Med. 2017 Jan;51(1):51-57. doi: 10.1136/bjsports-2016-096275. Epub 2016 Jul 26.</citation>
    <PMID>27461882</PMID>
  </reference>
  <reference>
    <citation>McCrea M, Meier T, Huber D, Ptito A, Bigler E, Debert CT, Manley G, Menon D, Chen JK, Wall R, Schneider KJ, McAllister T. Role of advanced neuroimaging, fluid biomarkers and genetic testing in the assessment of sport-related concussion: a systematic review. Br J Sports Med. 2017 Jun;51(12):919-929. doi: 10.1136/bjsports-2016-097447. Epub 2017 Apr 28.</citation>
    <PMID>28455364</PMID>
  </reference>
  <reference>
    <citation>Papa L. Potential Blood-based Biomarkers for Concussion. Sports Med Arthrosc Rev. 2016 Sep;24(3):108-15. doi: 10.1097/JSA.0000000000000117.</citation>
    <PMID>27482776</PMID>
  </reference>
  <reference>
    <citation>O'Connell B, Kelly AM, Mockler D, Oresic M, Denvir K, Farrell G, Janigro D, Wilson F. Use of Blood Biomarkers in the Assessment of Sports-Related Concussion-A Systematic Review in the Context of Their Biological Significance. Clin J Sport Med. 2018 Nov;28(6):561-571. doi: 10.1097/JSM.0000000000000478.</citation>
    <PMID>29035978</PMID>
  </reference>
  <reference>
    <citation>Jeter CB, Hergenroeder GW, Hylin MJ, Redell JB, Moore AN, Dash PK. Biomarkers for the diagnosis and prognosis of mild traumatic brain injury/concussion. J Neurotrauma. 2013 Apr 15;30(8):657-70. doi: 10.1089/neu.2012.2439.</citation>
    <PMID>23062081</PMID>
  </reference>
  <reference>
    <citation>Di Battista AP, Rhind SG, Baker AJ, Jetly R, Debad JD, Richards D, Hutchison MG. An investigation of neuroinjury biomarkers after sport-related concussion: from the subacute phase to clinical recovery. Brain Inj. 2018;32(5):575-582. doi: 10.1080/02699052.2018.1432892. Epub 2018 Feb 8.</citation>
    <PMID>29420083</PMID>
  </reference>
  <reference>
    <citation>Shahim P, Tegner Y, Marklund N, Blennow K, Zetterberg H. Neurofilament light and tau as blood biomarkers for sports-related concussion. Neurology. 2018 May 15;90(20):e1780-e1788. doi: 10.1212/WNL.0000000000005518. Epub 2018 Apr 13.</citation>
    <PMID>29653990</PMID>
  </reference>
  <reference>
    <citation>Ercole A, Thelin EP, Holst A, Bellander BM, Nelson DW. Kinetic modelling of serum S100b after traumatic brain injury. BMC Neurol. 2016 Jun 17;16:93. doi: 10.1186/s12883-016-0614-3.</citation>
    <PMID>27315805</PMID>
  </reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>May 30, 2023</last_update_submitted>
  <last_update_submitted_qc>May 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>blood-based biomarker</keyword>
  <keyword>prognosis</keyword>
  <keyword>SCAT5</keyword>
  <keyword>head injury assessment</keyword>
  <keyword>return to play protocol</keyword>
  <keyword>sports related concussion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Brain Concussion</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Athletic Injuries</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 8, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT04485494/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04485494
org study id: CRSU-016
nct id: NCT04485494
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The diagnosis of sports related concussion still relies heavily on a subjective assessment.
      In this study the investigators want to assess the prognostic value of blood-based biomarkers
      with recovery from concussive episodes over specific time points post-injury. Our research
      aims to (1) assess that the World Rugby's head injury assessment (HIA) can identify that a
      concussion has taken place by measuring specific biomarkers in the blood and (2) to track
      these biomarkers over time post-injury as a means to assess player health.
The diagnosis and prognosis of sports related concussion (SRC) still rely on a subjective
      assessment based on the SCAT5 procedure. Our knowledge of how sports related concussion
      effects an athlete over time is limited as all patients may have different recovery times
      from concussion. Our research aims to quantitatively confirm that the head injury assessment
      has predicted a concussion against clinical assessment (SCAT5) and that a return to play
      protocol allows sufficient recovery time for an athlete.

      Numerous novel areas of diagnosis are currently under investigation including protein-based
      biomarkers. In the context of SRC, these protein biomarkers typically consist of neurological
      proteins normally confined to the central nervous system or associated with neurological cell
      damage. Recent studies have compared biomarker levels at different time points post-diagnosis
      or investigated the relationship between early biomarker levels and return to play (RTP)
      times. However, the use of these biomarkers for actively evaluating player recovery following
      SRC has yet to be fully investigated. In this study, the investigators will measure
      biomarkers levels across multiple time points post-SRC to assess the value of these
      biomarkers to monitor player recovery. This is of significant for minimising premature RTP
      and, ultimately, aiming to reduce the chronic long-term effects associated with SRC.

      To truly identify a biomarker specific to concussion this study will need to, first, analyse
      the bloods of concussion patients and compare to the clinical assessment of the head injury
      assessment (HIA), and, second, measure their levels over time to indicate recovery that may
      aid in a safe return to play.

      Briefly, blood samples are taken from consented participants at the start of pre-season to
      act as a baseline. Once one of these participants enters the HIA process their bloods are
      taken post-injury, 6 days after injury and 13 days after injury. Next, the biomarkers are
      measured in the blood samples at each time point to examine if there is any increase/decrease
      in their levels.

      Study Design:

      A prospective cohort study with an uninjured and exercise free control groups.

      Population:

      All participants are professional rugby players from one professional rugby club were
      initially invited to participate. Initial contact was made to the Irish Rugby Football Union
      (IRFU) chief medical officer for permission to run the study over a three-year period. Next
      permission to run this cohort study was sought from the head coach and medical staff of the
      professional rugby team.

      Baseline Questionnaire:

      Participants will complete a baseline questionnaire that includes questions regarding their
      concussion history including symptoms associated with, length of, and outcome of previous
      injuries. The questionnaire was developed in line with previous sports-based concussion
      studies used for ice hockey and Australian football

      Timeframes

      As part of this study, any participant that enters the standard HIA process will undergo a
      HIA, a neuropsychometric assessment, and blood sampling at the following time points:

        1. Within 72 hours of injury,

        2. 6 days post-injury (± 1 day); this aligns with the minimum graduated return to play
           (GRTP) protocol for a professional rugby player, no player will return to play before 6
           days,

        3. 13 days post-injury (± 1 day) to examine if biomarkers are still present despite the
           results the HIA and the neuropsychometric assessment.

      Serial HIA Participants that suffer a suspected SRC will complete the HIA protocol at the
      time points outlined above. This is a form of the SCAT5 which has been modified for
      professional rugby and GRTP. This assessment will be carried out by the medical officer of
      the professional rugby club.

      Neuropsychometric Assessment During preseason players complete a baseline computed based
      neuropsychometric assessment - ImPACT. This assessment measures different cognitive domains
      including visual memory, visual processing speed, reaction times and working memory as well
      as attention. Post injury players are re-assessed once symptom free to determine recovery fo
      these domains and to assess for any persistent patterns of deficit. This assessment forms a
      part of the overall concussion assessment and management plan.

      Blood Draw:

      The medical officer and/or clinical nurse will take the samples of blood at the timepoints
      outlined above. The medical officer or nurse usually takes the blood sample from the
      antecubital vein in the arm.

      Bloods are collected by a member of the study team from the medical officer or nurse after
      the participant has left to ensure confidentiality. Three types of sample vials are used to
      ensure different types of biochemical techniques can be used and certain markers can be
      examined; serum, plasma and whole blood. Whole blood samples are immediately aliquoted in 2
      mL cryo-vials of 1- 1.5 mL each. For serum samples the blood is allowed to clot within the
      tube for up to 30 minutes. For both serum and plasma vials, they are centrifuged at 2,000 xg
      for 10 minutes at 4 °C. The serum and plasma are carefully pipetted and aliquoted into
      respective 2 mL cryo-vials with no less than 400 µL in each cryo-vial. All aliquoted
      cryo-vials are placed into storage boxes within a -80 °C freezer for long-term storage. Each
      aliquot can be removed to probe for different biomarkers without multiple freeze-thaw cycles
      on the core sample.

      Blood Biomarkers The blood-based biomarkers that can be analysed using standard biochemical
      techniques for a targeted and hypothesis-based procedures using ELISA kits or Luminex
      multiplex assays. Serum and plasma samples allows for a multitude of targets to be analysed
      which may be found in either serum or plasma. For this type of analysis common targets can be
      used to compare across the timepoints. The biomarkers under investigation can be but not
      limited to s100β, ubiquitin carboxyl-terminal hydrolase isoenzyme L1, glial fibrillar acidic
      protein and total, Tau protein and Brain-derived neurotrophic factor.

      Outcomes Each participant that is believed to have a SRC will enter the HIA process. These
      participants will have clinical assessments conducted at pre-defined time points, in line
      with the World Rugby guidelines. Blood samples will also be acquired at these time points to
      quantify the levels of blood-based biomarkers. Biomarker levels will be correlated to the
      results of the HIA and neuropsychometric assessments. This will facilitate preliminary
      investigation of the correlation between clinical assessments and biomarker levels to
      determine if the biomarkers can be used to objectively assess SRC recovery

      Investigations:

      A collaborative relationship exists between this research group and the University of
      Limericks (UL) Clinical Research Support Unit (CRSU). The CRSU provided advice and supported
      the delivery of this research project to the highest standard of research and clinical
      governance in accordance with the requirements of ICH Good Clinical Practice (ICH-GCP)
      Guidelines and all applicable regulatory requirements. The participant contact element of
      this study was conducted by adhering to the CRSU's Quality Management System (QMS).
observational model: Cohort
time perspective: Prospective
measure: Clinical Diagnosis
time frame: Bloods to be taken within 72 hours of injury
description: Measure the levels of blood biomarkers in rugby players that have experienced a concussion, confirmed via HIA and neuropsychometric assessment, to assess the utility of these biomarkers for concussion diagnosis
measure: Clinical Recovery
time frame: Bloods to be taken within 6 and 13 days post-injury
description: Track the levels of the blood biomarkers over time, post-injury to determine if biomarker levels correlate with clinical recovery.
arm group label: Professional Rugby Athletes
description: These are the cohort of players that consent to the study and have a preseason baseline blood sample taken. If the participant from this cohort then receives a concussion they are assessed by the World Rugby's Head Injury Assessment (HIA) and then enter into the return to play (RTP) protocol which means they cannot play a competitive game for 6 days.
intervention type: Diagnostic Test
intervention name: Biochemical Analysis of Blood Biomarkers
description: Using established biochemical techniques, the bloods will be probed for specific biomarkers s100B, UCH-L1, GFAP, and BDNF. The techniques include individual ELISA kits for each biomarker mentioned and Luminex multiplate assay which will probe for all biomarkers in one plate. Ultimately, these techniques will be able to measure the level of these biomarkers in the blood relative to the participants baseline reading.
arm group label: Professional Rugby Athletes
Blood samples at each time point are taken. Approximately, 30 mL of blood are drawn across 3
      vials to allow for collection of whole blood, serum and plasma from the same participant at
      each time point.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jamie Kearns, MD
role: Principal Investigator
affiliation: Munster Rugby
facility: 
country: Ireland
citation: Fuller CW, Taylor A, Kemp SP, Raftery M. Rugby World Cup 2015: World Rugby injury surveillance study. Br J Sports Med. 2017 Jan;51(1):51-57. doi: 10.1136/bjsports-2016-096275. Epub 2016 Jul 26.
PMID: 27461882
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responsible party type: Sponsor
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Brain Concussion
mesh term: Wounds and Injuries
mesh term: Athletic Injuries
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