Carbon Monoxide PoisoningCOMPsNCT05591300
Microparticles Blood Level in Acute Carbon Monoxide Poisoning
An observational study of Carbon Monoxide Poisoning, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.
Trial summary
The goal of this pilot, clinical, experimental, biological and prospective study with uso of biological material (venous blood sampling), in patient with acute carbon monoxide (CO) intoxication and in a group of healthy non-intoxicated subject (group of control) is the research of a possible increase of circulating… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Carbon Monoxide Poisoning
- What is being tested?
- Microparticles research
- How many people
- 108 participants
- Where
- 1 siteItaly
- Study dates
- 15 Nov 2022to Nov 2025
- How long will I take part?
- 45 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with CO poisoning that need hyperbaric oxygen treatment and afferent to the Hyperbaric center of the Nursing Home Habilita "I Cedri" located in Fara Novarese (NO). For every two intoxicated patients it will be necessary identify a healthy volunteer (matching 2:1) comparable with the patient intoxicated by sex, age (+/- 5 years), cigarette smoke.
Who may be able to join
- Age > 18 years
- Acute carbon monoxide poisoning
- Need for treatment with hyperbaric oxygen
Who cannot join
- Patient reject to consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
AOU Maggiore della Carità
Novara, 28100
Rosanna Vaschetto, 3342724811, rosanna.vaschetto@med.uniupo.it
Carlo Olivieri, MD
About this study
The goal of this pilot, clinical, experimental, biological and prospective study with uso of biological material (venous blood sampling), in patient with acute carbon monoxide (CO) intoxication and in a group of healthy non-intoxicated subject (group of control) is the research of a possible increase of circulating microparticles level in human blood with an acute carbon monoxide intoxication.
The main question to answer is:
Read more
Is there an increase of circulating microparticles levels in subjects with acute carbon monoxide poisoning? Two blood samples will be withdrawn from patients with acute carbon monoxide poisoning, one before and one after hyperbaric oxygen treatment.
Researchers will compare a group of healthy volunteers to see if there is a different in circulating microparticles blood level compared to patients with intoxication.
Read the detailed description
Few agents cause suffering like carbon monoxide (CO) in the humans. The CO pathophysiological mechanism extends beyond the hypoxic stress given by the COHb, and current knowledge cannot explain all of the lesions.
CO toxicity includes hypoxic and oxidative stress and implies long-term neurological morbidity. Patients exposed for a short time even to low concentrations of CO may show activation of intravascular neutrophils and increases in circulating inflammatory proteins.
The treatment of CO poisoning is administer normobaric or hyperbaric oxygen. One of the possible complications of CO poisoning is the delayed neurological syndrome.
Microvesicles are microparticles released by all eukaryotic cells and are involved in the intracellular communication, in physiological and pathological conditions.
In the human blood microparticles are present after exposure to tobacco smoke and air pollution.
Mouse model study proved the increased number of circulating microparticles in mice subjected to CO intoxication. Our study group hypothesized a possible increase of circulating microparticles in patient with CO poisoning compared to a population of healthy controls. Secondary objectives will be to assess the relationship between severity of intoxication and circulating microparticles level; risk fatcors for development of delayed neurological syndrome will be investigated. Finally, the types of microparticles involved in CO poisoning will be characterized.
The study population consists by all patients who need a hyperbaric treatment due to an acute CO poisoning in the region afferent to Nursing House Habilita "I Cedri", located in Fara Novarese; for every two patient a healty control will be identified.
When the patient will arrived in hyperbaric room, before the treatment (T0-time zero) a blood sample in sodium citrate will be taken, at the end of the treatment (T1-time one) another blood sample will be taken. The blood samples will then be sent to the laboratory of the Novara Hospital for the processing.
It will be administered a questionnaire for the mental status evaluation (Pfeiffer's Test) in T0 and 45 days after intoxication (T2-time two) by phone to assess the onset of delayed neurological syndrome.
- Conditions
- Carbon Monoxide Poisoning
- Being tested
- Microparticles research
- Keywords
- Carbon monoxide intoxication, Microparticles, Microvesicles, Carbon monoxide poisoning, CO, Delayed neurological syndrome, Hyperbaric Oxygen
- 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.
Microparticles researchDiagnostic test
The absolute count of the total circulating microparticles will be carried out on the patients' plasma using the NanoSight NS300 instrument (Alphatest). Furthermore, the circulating microparticles will be stained with a combination of three monoclonal antibodies (Becton and Dickinson, NJ,USA) to detect microparticles released by the most abundant cell populations in the blood: leukocyte-derived microparticles (CD45+), endothelial-derived microparticles (CD31+), and PLT-derived microparticles (CD31+ CD41a+).
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with acute CO poisoning needing a hyperbaric oxygen treatment Receives: Diagnostic Test: Microparticles research | |
| Healthy controls | Healthy controls i.e., healthy phisicians than will enter the hyperbaric oxygen therapy chamber to assist the patients Receives: Diagnostic Test: Microparticles research |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microparticles research
Quantify the number and the type of circulating microparticles in subjects after carbon monoxide poisoning.
Measured: 2 years
Secondary outcomes (3)
Relationship between poisoning severity and circulating microparticles levels
Evaluate the possible relationship between carbon monoxide poisoning severity measured as COHb levels and circulating microparticles levels before and after hyperbaric oxygen treatment.
Measured: 45 days
Risk factors of delayed neurological syndrome development
Research of risk factors of delayed neurological syndrome development and follow up with test of Pfeiffer.
Measured: 45 days
Proteomic and transcriptomic analysis
Researche the type of microparticles with proteomic and transcriptomic analysis
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start15 Nov 2022
- Primary completionApr 2025 (estimated)
- Study completionNov 2025 (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-control
- Time perspective
- Prospective
- Enrolment
- 108 participants (estimated)
- Target duration
- 45 Days
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita
- Sponsor type
- University, hospital or other
- Collaborators
- Università degli Studi del Piemonte Orientale Amedeo Avogadro
- Responsible party
- Principal investigator, Rosanna Vaschetto, MD, PhD, Azienda Ospedaliero Universitaria Maggiore della Carita
- Investigators
- Rosanna Vaschetto, MD, PhD, Principal investigator, University of Eastern Piedmont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05591300
- Sponsor's protocol ID
- AOCarita1
- Acronym
- COMPs
- Status last verified
- Nov 2024
- First submitted
- 19 Oct 2022
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data properties will be maintained by the center involved in the study. Pseudonymized data will not be transferred in other countries outside European Union. Principal investigator will considered data shearing after reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microparticles Blood Level in Acute Carbon Monoxide Poisoning
- ClinicalTrials.gov ID
- NCT05591300
- Acronym / sponsor ID
- COMPs / AOCarita1
- Conditions
- Carbon Monoxide Poisoning
- Keywords
- Carbon monoxide intoxication, Microparticles, Microvesicles, Carbon monoxide poisoning, CO, Delayed neurological syndrome, Hyperbaric Oxygen
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della CaritaUniversity, hospital or other
- Collaborators
- Università degli Studi del Piemonte Orientale Amedeo Avogadro
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 24 Oct 2022 (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.
The goal of this pilot, clinical, experimental, biological and prospective study with uso of biological material (venous blood sampling), in patient with acute carbon monoxide (CO) intoxication and in a group of healthy non-intoxicated subject (group of control) is the research of a possible increase of circulating microparticles level in human blood with an acute carbon monoxide intoxication.
The main question to answer is:
Is there an increase of circulating microparticles levels in subjects with acute carbon monoxide poisoning? Two blood samples will be withdrawn from patients with acute carbon monoxide poisoning, one before and one after hyperbaric oxygen treatment.
Researchers will compare a group of healthy volunteers to see if there is a different in circulating microparticles blood level compared to patients with intoxication.
Detailed description
Few agents cause suffering like carbon monoxide (CO) in the humans. The CO pathophysiological mechanism extends beyond the hypoxic stress given by the COHb, and current knowledge cannot explain all of the lesions.
CO toxicity includes hypoxic and oxidative stress and implies long-term neurological morbidity. Patients exposed for a short time even to low concentrations of CO may show activation of intravascular neutrophils and increases in circulating inflammatory proteins.
The treatment of CO poisoning is administer normobaric or hyperbaric oxygen. One of the possible complications of CO poisoning is the delayed neurological syndrome.
Microvesicles are microparticles released by all eukaryotic cells and are involved in the intracellular communication, in physiological and pathological conditions.
In the human blood microparticles are present after exposure to tobacco smoke and air pollution.
Mouse model study proved the increased number of circulating microparticles in mice subjected to CO intoxication. Our study group hypothesized a possible increase of circulating microparticles in patient with CO poisoning compared to a population of healthy controls. Secondary objectives will be to assess the relationship between severity of intoxication and circulating microparticles level; risk fatcors for development of delayed neurological syndrome will be investigated. Finally, the types of microparticles involved in CO poisoning will be characterized.
The study population consists by all patients who need a hyperbaric treatment due to an acute CO poisoning in the region afferent to Nursing House Habilita "I Cedri", located in Fara Novarese; for every two patient a healty control will be identified.
When the patient will arrived in hyperbaric room, before the treatment (T0-time zero) a blood sample in sodium citrate will be taken, at the end of the treatment (T1-time one) another blood sample will be taken. The blood samples will then be sent to the laboratory of the Novara Hospital for the processing.
It will be administered a questionnaire for the mental status evaluation (Pfeiffer's Test) in T0 and 45 days after intoxication (T2-time two) by phone to assess the onset of delayed neurological syndrome.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 45 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Diagnostic Test: Microparticles researchPatients with acute CO poisoning needing a hyperbaric oxygen treatment |
| Healthy controls | – | Diagnostic Test: Microparticles researchHealthy controls i.e., healthy phisicians than will enter the hyperbaric oxygen therapy chamber to assist the patients |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with CO poisoning that need hyperbaric oxygen treatment and afferent to the Hyperbaric center of the Nursing Home Habilita "I Cedri" located in Fara Novarese (NO). For every two intoxicated patients it will be necessary identify a healthy volunteer (matching 2:1) comparable with the patient intoxicated by sex, age (+/- 5 years), cigarette smoke.
Key inclusion criteria (3 listed)
- Age > 18 years
- Acute carbon monoxide poisoning
- Need for treatment with hyperbaric oxygen
Key exclusion criteria (1 listed)
- Patient reject to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microparticles researchThe absolute count of the total circulating microparticles will be carried out on the patients' plasma using the NanoSight NS300 instrument (Alphatest). Furthermore, the circulating microparticles will be stained with a combination of three monoclonal antibodies (Becton and Dickinson, NJ,USA) to detect microparticles released by the most abundant cell populations in the blood: leukocyte-derived microparticles (CD45+), endothelial-derived microparticles (CD31+), and PLT-derived microparticles (CD31+ CD41a+). | Diagnostic test | Healthy controls, Patients |
Primary outcome
Microparticles research
Time frame: 2 years
Quantify the number and the type of circulating microparticles in subjects after carbon monoxide poisoning.
3 secondary outcomes
Relationship between poisoning severity and circulating microparticles levels
Time frame: 45 days
Risk factors of delayed neurological syndrome development
Time frame: 45 days
Proteomic and transcriptomic analysis
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Individual participant dataSharing planned: Undecided. Data properties will be maintained by the center involved in the study. Pseudonymized data will not be transferred in other countries outside European Union. Principal investigator will considered data shearing after reasonable request.
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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.
Rosanna Vaschetto, MD, PhD principal investigator
University of Eastern Piedmont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carbon Monoxide Poisoning, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.
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 1 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: looking for participants now, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rosanna Vaschetto (+39 3342724811, rosanna.vaschetto@med.uniupo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microparticles research (time frame: 2 years). 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 14 Nov 2024.