Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04475263
Other study ID # 2019.0375
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 1, 2020
Est. completion date December 1, 2021

Study information

Verified date October 2020
Source St George's, University of London
Contact Peter O Jenkins, PhD
Phone 020 82666866
Email peter.jenkins1@nhs.net
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date December 1, 2021
Est. primary completion date December 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 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 Exclusion Criteria: - age <18 years - actual or suspected smoke inhalation - significant neurological or psychiatric illness prior to CO exposure - inability to provide consent

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
St George's, University of London University College, London

Outcome

Type Measure Description Time frame Safety issue
Primary Blood biomarker level of neurofilament light in participants with proven CO exposure. Plasma levels of neurofilament light will be measured 18 months
Secondary Blood biomarker level of tau in participants with proven CO exposure. Plasma levels of tau will be measured 18 months
Secondary Blood biomarker level of glial fibrillary acidic protein in participants with proven CO exposure. Plasma levels of glial fibrillary acidic protein will be measured 18 months
Secondary 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. 18 months
Secondary 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. 18 months
Secondary 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. 18 months
Secondary 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. 18 months
Secondary 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. 18 months
Secondary 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. 18 months
Secondary 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. 18 months
Secondary 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. 18 months
See also
  Status Clinical Trial Phase
Completed NCT03669848 - Is Transcutaneous Carbon Monoxide Saturation of E-cigarette Users Comparable to That of Smokers?
Completed NCT04656912 - Hyperbaric Oxygen Therapy Initiation Time in Acute Carbon Monoxide Poisoning
Recruiting NCT04975867 - Adjunct Targeted Temperature Management in Acute Severe Carbon Monoxide Poisoning N/A
Terminated NCT01100515 - Hyperbaric Oxygen Therapy for Acute Domestic Carbon Monoxide (CO) Poisoning Phase 3
Terminated NCT01099995 - Hyperbaric Oxygen Therapy for Comatose Patients With Acute Carbon Monoxide Poisoning Phase 3
Terminated NCT03017742 - Utility of Non-invasive Carboxyhemoglobin and Total Hemoglobin Measurement in the Emergency Department
Terminated NCT01059708 - Outcome Following Carbon Monoxide Poisoning in Children N/A
Recruiting NCT05591300 - Microparticles Blood Level in Acute Carbon Monoxide Poisoning
Completed NCT03926494 - Carbon Monoxide-induced Coma: Prognostic Factors
Recruiting NCT02375126 - Normal Quantitative EEG (qEEG) Dataset
Completed NCT03342209 - Utility of High Flow Nasal Cannula in CO Toxicity N/A
Completed NCT00465855 - One vs. Three Hyperbaric Oxygen Treatments for Acute Carbon Monoxide Poisoning Phase 4
Recruiting NCT04490317 - CARbon monoxidE intoxiCatiOn in Korea: Prospective Cohort (CARE CO Cohort)
Withdrawn NCT04118491 - Hyperbaric Oxygen for Carbon Monoxide Induced Chronic Encephalopathy N/A
Unknown status NCT00841165 - Carbon Monoxide Monitoring and Emergency Treatment N/A
Withdrawn NCT00280579 - Cyanide Poisoning in Fire Victims N/A
Enrolling by invitation NCT02483650 - Hyperbaric Oxygen Therapy Registry
Completed NCT05088005 - Prognostic Biomarkers in CO Poisoning
Completed NCT03030833 - Dysfunctional Hemoglobin Pulse Oximetry N/A
Recruiting NCT02860455 - Role of Pulse Co-oximetry for Detecting Carbon Monoxide Poisoning in the Prehospital Emergency Medical Service Setting N/A