Blood-based Biomarkers for the Prognosis of Sports Related Concussion

NCT04485494 | Completed

• 1 other identifier: CRSU-016
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Traumatic Brain Injury; Sports Injury; Concussion, Mild

Keywords

blood-based biomarker; prognosis; SCAT5; head injury assessment; return to play protocol; sports related concussion

Outcome Measures

Primary Outcomes (2)

• Clinical Diagnosis

  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

  Bloods to be taken within 72 hours of injury

• Clinical Recovery

  Track the levels of the blood biomarkers over time, post-injury to determine if biomarker levels correlate with clinical recovery.

  Bloods to be taken within 6 and 13 days post-injury

Study Arms (1)

Professional Rugby Athletes

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.

Diagnostic Test: Biochemical Analysis of Blood Biomarkers

Interventions

Biochemical Analysis of Blood Biomarkers DIAGNOSTIC_TEST

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.

Professional Rugby Athletes

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All participants are professional rugby players from a professional rugby club were have been 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.

You may qualify if:

• Participants are eligible to participate if they
• are part of the professional rugby team's senior squad or the academy;
• aged over 18;
• consent to the study over the whole season.

You may not qualify if:

• Participants are excluded if they
• are unable to attend the preseason baseline draw;
• unable to give informed consent.

Sponsors & Collaborators

• University of Limerick: lead

Study Sites (1)

Munster Rugby

Limerick, Munster, Ireland

Location

Related Publications (9)

• 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 BACKGROUND

• 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.

  PMID: 28455364 BACKGROUND

• Papa L. Potential Blood-based Biomarkers for Concussion. Sports Med Arthrosc Rev. 2016 Sep;24(3):108-15. doi: 10.1097/JSA.0000000000000117.

  PMID: 27482776 BACKGROUND

• 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.

  PMID: 29035978 BACKGROUND

• 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.

  PMID: 23062081 BACKGROUND

• 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.

  PMID: 29420083 BACKGROUND

• 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.

  PMID: 29653990 BACKGROUND

• 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.

  PMID: 27315805 BACKGROUND

• Kearns J, Ross AM, Walsh DR, Cahalane RM, Hinchion R, Ryan MC, Conway E, Comyns TM, Kenny IC, O'Connor EM, McGourty KD, Mulvihill JJE. A blood biomarker and clinical correlation cohort study protocol to diagnose sports-related concussion and monitor recovery in elite rugby. BMJ Open Sport Exerc Med. 2020 Nov 26;6(1):e000948. doi: 10.1136/bmjsem-2020-000948. eCollection 2020.

  PMID: 34422289 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Brain Injuries, Traumatic; Athletic Injuries; Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Head Injuries, Closed; Wounds, Nonpenetrating

Study Officials

• Jamie Kearns, MD

  Munster Rugby

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: July 24, 2020
• Study Start: July 1, 2018
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: June 2, 2023

Record last verified: 2023-05

Locations

IE (1)