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Microparticles Blood Level in Acute Carbon Monoxide Poisoning

Microparticles Blood Level in Acute Carbon Monoxide Poisoning

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05591300
Acronym
COMPs
Enrollment
108
Registered
2022-10-24
Start date
2022-11-15
Completion date
2025-11-30
Last updated
2024-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carbon Monoxide Poisoning

Keywords

Carbon monoxide intoxication, Microparticles, Microvesicles, Carbon monoxide poisoning, CO, Delayed neurological syndrome, Hyperbaric Oxygen

Brief 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 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 Two blood samples will be withdrawn from patients with acute carbon monoxide poisoning, one before and one after hyperbaric oxygen treatment.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.

Interventions

DIAGNOSTIC_TESTMicroparticles research

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+).

Sponsors

Università degli Studi del Piemonte Orientale Amedeo Avogadro
CollaboratorOTHER
Azienda Ospedaliero Universitaria Maggiore della Carita
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes

Inclusion criteria

* Age \> 18 years * Acute carbon monoxide poisoning * Need for treatment with hyperbaric oxygen

Exclusion criteria

* Patient reject to consent

Design outcomes

Primary

MeasureTime frameDescription
Microparticles research2 yearsQuantify the number and the type of circulating microparticles in subjects after carbon monoxide poisoning.

Secondary

MeasureTime frameDescription
Relationship between poisoning severity and circulating microparticles levels45 daysEvaluate the possible relationship between carbon monoxide poisoning severity measured as COHb levels and circulating microparticles levels before and after hyperbaric oxygen treatment.
Risk factors of delayed neurological syndrome development45 daysResearch of risk factors of delayed neurological syndrome development and follow up with test of Pfeiffer.
Proteomic and transcriptomic analysis2 yearsResearche the type of microparticles with proteomic and transcriptomic analysis

Countries

Italy

Contacts

Primary ContactRosanna Vaschetto
rosanna.vaschetto@med.uniupo.it+39 3342724811

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026