Carbon Monoxide PoisoningNCT04475263
Cognitive and Blood Biomarker Assessment After CO Exposure
An observational study of Carbon Monoxide Poisoning, run by St George's, University of London.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carbon Monoxide Poisoning
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2020to 1 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 50 individuals with confirmed evidence of CO exposure will be recruited.
Who may be able to join
- 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
Who cannot join
- age <18 years
- actual or suspected smoke inhalation
- significant neurological or psychiatric illness prior to CO exposure
- inability to provide consent
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Cognitive, Behavioural and Blood Biomarker Assessment After Carbon Monoxide (CO) Exposure
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
- Medical subject headings
- Carbon Monoxide Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Carbon monoxide exposure | Confirmed exposure to carbon monoxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood biomarker level of neurofilament light in participants with proven CO exposure.
Plasma levels of neurofilament light will be measured
Measured: 18 months
Secondary outcomes (10)
Blood biomarker level of tau in participants with proven CO exposure.
Plasma levels of tau will be measured
Measured: 18 months
Blood biomarker level of glial fibrillary acidic protein in participants with proven CO exposure.
Plasma levels of glial fibrillary acidic protein will be measured
Measured: 18 months
Behavioural questionnaire: depression (Patient Health Questionnaire - part 9)
Participants will be asked to complete a validated questionnaire assessing fatigue, depression, anxiety, post-traumatic stress symptoms, problems with attention, quality of life, return to work and illness perceptions. All questionnaires provide a numerical score.
Measured: 18 months
Behavioural questionnaire: anxiety (Generalised Anxiety Disorder Questionnaire - GAD7)
Participants will be asked to complete validated questionnaires assessing fatigue, depression, anxiety, post-traumatic stress symptoms, problems with attention, quality of life, return to work and illness perceptions. All questionnaires provide a numerical score.
Measured: 18 months
Behavioural questionnaire: post-traumatic stress symptoms (Impact of Events Scale)
Participants will be asked to complete validated questionnaires assessing fatigue, depression, anxiety, post-traumatic stress symptoms, problems with attention, quality of life, return to work and illness perceptions. All questionnaires provide a numerical score.
Measured: 18 months
Behavioural questionnaire: Attentional behaviour (Rating Scale of Attentional Behaviour)
Participants will be asked to complete validated questionnaires assessing fatigue, depression, anxiety, post-traumatic stress symptoms, problems with attention, quality of life, return to work and illness perceptions. All questionnaires provide a numerical score.
Measured: 18 months
Behavioural questionnaire: fatigue (Visual Analogue Scale of Fatigue)
Participants will be asked to complete validated questionnaires assessing fatigue, depression, anxiety, post-traumatic stress symptoms, problems with attention, quality of life, return to work and illness perceptions. All questionnaires provide a numerical score.
Measured: 18 months
Behavioural questionnaire: Quality of life (The Short Form (36) Health Survey)
Participants will be asked to complete validated questionnaires assessing fatigue, depression, anxiety, post-traumatic stress symptoms, problems with attention, quality of life, return to work and illness perceptions. All questionnaires provide a numerical score.
Measured: 18 months
Behavioural questionnaire: return to work/social activities (Work and Social Adjustment Scale)
Participants will be asked to complete validated questionnaires assessing fatigue, depression, anxiety, post-traumatic stress symptoms, problems with attention, quality of life, return to work and illness perceptions. All questionnaires provide a numerical score.
Measured: 18 months
Cognitive assessment
Participants will complete a battery of cognitive assessments with a large normative control population. Cognitive tests will assess speed of information processing, reasoning, memory and visuospatial abilities. All results will be a numerical result.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start1 Nov 2020 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carbon Monoxide PoisoningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Collaborators
- University College, London
- Responsible party
- Sponsor
- Investigators
- Peter O Jenkins, PhD, Principal investigator, St. George's Hospital, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04475263
- Sponsor's protocol ID
- 2019.0375
- Status last verified
- Oct 2020
- First submitted
- 20 Mar 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification. Proposals should be directed to peter.jenkins1@nhs.net. To gain access, data requestors will need to sign a data access agreement.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive, Behavioural and Blood Biomarker Assessment After Carbon Monoxide (CO) Exposure
- ClinicalTrials.gov ID
- NCT04475263
- Acronym / sponsor ID
- 2019.0375
- Conditions
- Carbon Monoxide Poisoning
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Collaborators
- University College, London
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 17 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carbon monoxide exposure | – | –Confirmed exposure to carbon monoxide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 50 individuals with confirmed evidence of CO exposure will be recruited.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- age <18 years
- actual or suspected smoke inhalation
- significant neurological or psychiatric illness prior to CO exposure
- inability to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood biomarker level of neurofilament light in participants with proven CO exposure.
Time frame: 18 months
Plasma levels of neurofilament light will be measured
10 secondary outcomes
Blood biomarker level of tau in participants with proven CO exposure.
Time frame: 18 months
Blood biomarker level of glial fibrillary acidic protein in participants with proven CO exposure.
Time frame: 18 months
Behavioural questionnaire: depression (Patient Health Questionnaire - part 9)
Time frame: 18 months
Behavioural questionnaire: anxiety (Generalised Anxiety Disorder Questionnaire - GAD7)
Time frame: 18 months
Behavioural questionnaire: post-traumatic stress symptoms (Impact of Events Scale)
Time frame: 18 months
Behavioural questionnaire: Attentional behaviour (Rating Scale of Attentional Behaviour)
Time frame: 18 months
Behavioural questionnaire: fatigue (Visual Analogue Scale of Fatigue)
Time frame: 18 months
Behavioural questionnaire: Quality of life (The Short Form (36) Health Survey)
Time frame: 18 months
Behavioural questionnaire: return to work/social activities (Work and Social Adjustment Scale)
Time frame: 18 months
Cognitive assessment
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification. Proposals should be directed to peter.jenkins1@nhs.net. To gain access, data requestors will need to sign a data access agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter O Jenkins, PhD principal investigator
St. George's Hospital, London
Questions about this trial
What is this clinical trial studying?
An observational study of Carbon Monoxide Poisoning, run by St George's, University of London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter O Jenkins, PhD (020 82666866, peter.jenkins1@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood biomarker level of neurofilament light in participants with proven CO exposure. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.