Cognitive and Blood Biomarker Assessment After CO Exposure

NCT04475263 | Unknown

• 1 other identifier: 2019.0375
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Carbon monoxide (CO) is reported to cause around 30 deaths, 200 admissions and 4000 presentations to Emergency Departments each year in the UK. In the longer term, CO poisoning is recognised to cause persistent neurological problems (including impairments of thinking and behavioural changes), which can develop days to weeks after the initial exposure. However, the incidence of these long-term sequelae is unknown. In addition, there is evidence of long-lasting inflammatory changes in the brain and on-going brain cell injury, although how long this persists is also unknown. Initial assessments of CO exposure can be unreliable if blood tests are not carried out within a relatively short period after the exposure and other biomarkers (such as imaging) are insensitive to detecting previous CO exposure. Certain proteins that are found in brain cells can be detected in the blood of individuals following brain injury and brain cell death. These proteins have been found to be raised in the acute period after minor head injury, persistently raised in patients with a traumatic brain injury and evidence of on going neurodegeneration (i.e. on going brain cell death) and in patients with various types of dementia. The investigators will assess the presence of these proteins in the blood of 50 participants with proven CO exposure in the sub-acute to chronic timescale (2 weeks to 2 years). This has not been done before and will allow assessment of the presence of on going brain injury in these participants. The investigators will also assess cognitive (e.g. memory, attention and speed of thinking) and behavioural impairments in these participants to help characterise the common impairments suffered following CO exposure and relate these to evidence of persistent brain injury and severity of CO exposure.

Conditions

Carbon Monoxide Poisoning

Outcome Measures

Primary Outcomes (1)

• Blood biomarker level of neurofilament light in participants with proven CO exposure.

  Plasma levels of neurofilament light will be measured

  18 months

Secondary Outcomes (10)

• Blood biomarker level of tau in participants with proven CO exposure.

  18 months

• Blood biomarker level of glial fibrillary acidic protein in participants with proven CO exposure.

  18 months

• Behavioural questionnaire: depression (Patient Health Questionnaire - part 9)

  18 months

• Behavioural questionnaire: anxiety (Generalised Anxiety Disorder Questionnaire - GAD7)

  18 months

• Behavioural questionnaire: post-traumatic stress symptoms (Impact of Events Scale)

  18 months

Study Arms (1)

Carbon monoxide exposure

Confirmed exposure to carbon monoxide

Eligibility Criteria

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

Study Population

50 individuals with confirmed evidence of CO exposure will be recruited.

You may qualify if:

• Individuals identified as having confirmed exposure to CO between 2 weeks to 2 years at time of assessment. CO exposure determined by either;
• documented COHb levels above 1.6% in non-smokers and above 6.3% in smokers.
• or, individuals with evidence of being exposed to raised levels of CO and symptoms

You may not qualify if:

• age \<18 years
• actual or suspected smoke inhalation
• significant neurological or psychiatric illness prior to CO exposure
• inability to provide consent

Sponsors & Collaborators

• St George's, University of London: lead
• University College, London: collaborator

MeSH Terms

Conditions

Carbon Monoxide Poisoning

Condition Hierarchy (Ancestors)

Gas Poisoning; Poisoning; Chemically-Induced Disorders

Study Officials

• Peter O Jenkins, PhD

  St. George's Hospital, London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter O Jenkins, PhD

CONTACT

020 82666866; peter.jenkins1@nhs.net

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: July 17, 2020
• Study Start: November 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata.
• Access Criteria: Researchers who provide a methodologically sound proposal.