NCT Number: NCT05591300
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 Two blood samples will be withdrawn from patients with acute carbon monoxide poisoning, one before and one after hyperbaric oxygen treatment.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.
Interested in participating?
Request Info18 year–99 year
All sexes
Observational
Novara, 28100, Italy
Location status: Recruiting
Andrea Giovanniello, MD
SUB_INVESTIGATOR
Carlo Olivieri, MD
SUB_INVESTIGATOR
Davide Colombo, MD
SUB_INVESTIGATOR
Puggioni Angelo, MD
SUB_INVESTIGATOR
Racca Fabrizio, MD
SUB_INVESTIGATOR
Rosanna Vaschetto
CONTACT
Zorzi Stefano, MD
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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+).
Time frame: 2 years
Quantify the number and the type of circulating microparticles in subjects after carbon monoxide poisoning.
Time frame: 45 days
Evaluate the possible relationship between carbon monoxide poisoning severity measured as COHb levels and circulating microparticles levels before and after hyperbaric oxygen treatment.
Time frame: 45 days
Research of risk factors of delayed neurological syndrome development and follow up with test of Pfeiffer.
Time frame: 2 years
Researche the type of microparticles with proteomic and transcriptomic analysis
Contact information is provided by the study sponsor or research team.
Azienda Ospedaliero Universitaria Maggiore della Carita
Other
Acronym: COMPs
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