TBI Multimodal Monitoring Study

NCT02993549 | Unknown

• 1 other identifier: A094233
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Head injury is a common and devastating condition that can affect people at any stage of their lives. The treatment of severe head injury takes place in intensive care where interventions are designed to protect the brain from further injury and provide the best environment for recovery. A number of different monitors are used after head injury, including a monitor called microdialysis, to measure how the brain is generating energy. Abnormalities in these monitors guide doctors to the right treatments when the brain is at risk of further injury. There are lots of ways that the brain can be injured further after head injury such as raised pressure in the skull from brain swelling, low oxygen levels and low glucose levels. In this study we aim to combine information from all of these monitors to figure out what the underlying problem is and choose the right intervention to treat the problem that is affecting the patient at the time and compare this with previous treatment protocols to see if it improved outcome. Aim: To establish and validate a protocol to treat abnormalities in a microdialysis measure called lactate/pyruvate ratio (LPR) that reflects how cells are generating energy, and compare it with patient cohorts not being monitored using the current protocol.

Conditions

Traumatic Brain INjury; Microdialysis

Outcome Measures

Primary Outcomes (2)

• LPR <25

  Decrease of lactate:pyruvate ratio to below 25

  During neuro-critical care (the first 10 days following trauma).

• Different pathological targets

  How many patients have the different pathological targets, including 1. Intracranial hypertension (LPR corrected if ICP \<20mmHg), 2. Delivery failure (if LPR is corrected when PbO2 is improved and CPP increased). 3.Oxygen Diffusion Barrier (LPR is corrected if PbO2 is increased through FiO2 increase). 4. Neuroglycopenia (LPR is corrected if brain glucose is increased) or 5. Mitochondrial dysfunction (LPR remains increased despite all the therapies applied).

  During the neuro-critical care period (first 10 days after trauma)

Secondary Outcomes (4)

• Monitoring correlation

  During the neuro-critical care period (first 10 days after trauma)

• Functional Outcome

  6 months following injury

• Cytokine concentration in MD

  During the neuro-critical care period (first 10 days after trauma)

• Biomarker concentration in serum

  During the neuro-critical care (first 10 days after trauma)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients suffering from traumatic brain injury in need of intracranial monitoring admitted to the neuro-critical care unit at Addenbrooke's hospital, Cambridge, England.

You may qualify if:

• Patients with head injury requiring ICP monitoring
• Age 18-65 years
• Abnormal CT scan

You may not qualify if:

• Bilateral fixed and dilated pupils
• Bleeding diathesis
• Thrombocytopenia (platelets \< 100)
• Devastating injuries; patient not expected to survive \> 24 hours
• Brainstem damage
• Pregnancy
• Involvement in other studies non-observational studies
• MD catheter located in haemorrhagic lesion

Sponsors & Collaborators

• University of Cambridge: lead
• Cambridge University Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

Cambridge University Hospital NHS Trust

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

RECRUITING

Related Publications (17)

• Hyder AA, Wunderlich CA, Puvanachandra P, Gururaj G, Kobusingye OC. The impact of traumatic brain injuries: a global perspective. NeuroRehabilitation. 2007;22(5):341-53.

  PMID: 18162698 BACKGROUND

• Jennett B. Epidemiology of head injury. J Neurol Neurosurg Psychiatry. 1996 Apr;60(4):362-9. doi: 10.1136/jnnp.60.4.362. No abstract available.

  PMID: 8774396 BACKGROUND

• Jennett B, MacMillan R. Epidemiology of head injury. Br Med J (Clin Res Ed). 1981 Jan 10;282(6258):101-4. doi: 10.1136/bmj.282.6258.101.

  PMID: 6779889 BACKGROUND

• Hutchinson PJ, Kirkpatrick PJ, Addison J, Jackson S, Pickard JD. The management of minor traumatic brain injury. J Accid Emerg Med. 1998 Mar;15(2):84-8. doi: 10.1136/emj.15.2.84.

  PMID: 9570046 BACKGROUND

• Masel BE, DeWitt DS. Traumatic brain injury: a disease process, not an event. J Neurotrauma. 2010 Aug;27(8):1529-40. doi: 10.1089/neu.2010.1358.

  PMID: 20504161 BACKGROUND

• Werner C, Engelhard K. Pathophysiology of traumatic brain injury. Br J Anaesth. 2007 Jul;99(1):4-9. doi: 10.1093/bja/aem131.

  PMID: 17573392 BACKGROUND

• Carney N, Lujan S, Dikmen S, Temkin N, Petroni G, Pridgeon J, Barber J, Machamer J, Cherner M, Chaddock K, Hendrix T, Rondina C, Videtta W, Celix JM, Chesnut R. Intracranial pressure monitoring in severe traumatic brain injury in latin america: process and methods for a multi-center randomized controlled trial. J Neurotrauma. 2012 Jul 20;29(11):2022-9. doi: 10.1089/neu.2011.2019. Epub 2012 May 15.

  PMID: 22435793 BACKGROUND

• Timofeev I, Carpenter KL, Nortje J, Al-Rawi PG, O'Connell MT, Czosnyka M, Smielewski P, Pickard JD, Menon DK, Kirkpatrick PJ, Gupta AK, Hutchinson PJ. Cerebral extracellular chemistry and outcome following traumatic brain injury: a microdialysis study of 223 patients. Brain. 2011 Feb;134(Pt 2):484-94. doi: 10.1093/brain/awq353. Epub 2011 Jan 18.

  PMID: 21247930 BACKGROUND

• Sarrafzadeh AS, Sakowitz OW, Callsen TA, Lanksch WR, Unterberg AW. Bedside microdialysis for early detection of cerebral hypoxia in traumatic brain injury. Neurosurg Focus. 2000 Nov 15;9(5):e2. doi: 10.3171/foc.2000.9.5.2.

  PMID: 16821754 BACKGROUND

• Nortje J, Gupta AK. The role of tissue oxygen monitoring in patients with acute brain injury. Br J Anaesth. 2006 Jul;97(1):95-106. doi: 10.1093/bja/ael137. Epub 2006 Jun 3.

  PMID: 16751641 BACKGROUND

• Smielewski P, Coles JP, Fryer TD, Minhas PS, Menon DK, Pickard JD. Integrated image analysis solutions for PET datasets in damaged brain. J Clin Monit Comput. 2002 Dec;17(7-8):427-40. doi: 10.1023/a:1026293611455.

  PMID: 14650638 BACKGROUND

• Vespa PM, McArthur D, O'Phelan K, Glenn T, Etchepare M, Kelly D, Bergsneider M, Martin NA, Hovda DA. Persistently low extracellular glucose correlates with poor outcome 6 months after human traumatic brain injury despite a lack of increased lactate: a microdialysis study. J Cereb Blood Flow Metab. 2003 Jul;23(7):865-77. doi: 10.1097/01.WCB.0000076701.45782.EF.

  PMID: 12843790 BACKGROUND

• Verweij BH, Muizelaar JP, Vinas FC, Peterson PL, Xiong Y, Lee CP. Impaired cerebral mitochondrial function after traumatic brain injury in humans. J Neurosurg. 2000 Nov;93(5):815-20. doi: 10.3171/jns.2000.93.5.0815.

  PMID: 11059663 BACKGROUND

• Nordstrom CH, Nielsen TH, Schalen W, Reinstrup P, Ungerstedt U. Biochemical indications of cerebral ischaemia and mitochondrial dysfunction in severe brain trauma analysed with regard to type of lesion. Acta Neurochir (Wien). 2016 Jul;158(7):1231-40. doi: 10.1007/s00701-016-2835-z. Epub 2016 May 17.

  PMID: 27188288 BACKGROUND

• Lazaridis C, Robertson CS. The Role of Multimodal Invasive Monitoring in Acute Traumatic Brain Injury. Neurosurg Clin N Am. 2016 Oct;27(4):509-17. doi: 10.1016/j.nec.2016.05.010.

  PMID: 27637400 BACKGROUND

• Faul M, Wald MM, Rutland-Brown W, Sullivent EE, Sattin RW. Using a cost-benefit analysis to estimate outcomes of a clinical treatment guideline: testing theBrain Trauma Foundation guidelines for the treatment of severe traumatic brain injury. J Trauma. 2007 Dec;63(6):1271-8. doi: 10.1097/TA.0b013e3181493080.

  PMID: 18212649 BACKGROUND

• Hutchinson PJ, Jalloh I, Helmy A, Carpenter KL, Rostami E, Bellander BM, Boutelle MG, Chen JW, Claassen J, Dahyot-Fizelier C, Enblad P, Gallagher CN, Helbok R, Hillered L, Le Roux PD, Magnoni S, Mangat HS, Menon DK, Nordstrom CH, O'Phelan KH, Oddo M, Perez Barcena J, Robertson C, Ronne-Engstrom E, Sahuquillo J, Smith M, Stocchetti N, Belli A, Carpenter TA, Coles JP, Czosnyka M, Dizdar N, Goodman JC, Gupta AK, Nielsen TH, Marklund N, Montcriol A, O'Connell MT, Poca MA, Sarrafzadeh A, Shannon RJ, Skjoth-Rasmussen J, Smielewski P, Stover JF, Timofeev I, Vespa P, Zavala E, Ungerstedt U. Consensus statement from the 2014 International Microdialysis Forum. Intensive Care Med. 2015 Sep;41(9):1517-28. doi: 10.1007/s00134-015-3930-y.

  PMID: 26194024 BACKGROUND

Related Links

• Head injury statistics in the UK

Biospecimen

Retention: SAMPLES WITH DNA

Serum and cerebrospinal fluid if available. Microdialysis samples.

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Adel Helmy, MA MB BChir FRCS PhD

CONTACT

00441223 336946; adelhelmy@doctors.org.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University Lecturer Neurosurgery

Study Record Dates

• First Submitted: December 7, 2016
• First Posted: December 15, 2016
• Study Start: September 16, 2017
• Primary Completion: January 1, 2022
• Study Completion: October 1, 2022
• Last Updated: July 14, 2020

Record last verified: 2020-07

Locations

GB (1)