An observational study in Carbon Monoxide Poisoning, sponsored by Azienda Ospedaliero Universitaria Maggiore della Carita. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-14.
Sponsored by Azienda Ospedaliero Universitaria Maggiore della Carita · Observational
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 Two blood samples will be withdrawn from patients with acute carbon monoxide poisoning, one before and one after hyperbaric oxygen treatment.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.
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.
44 studies on the registry are indexed under Carbon Monoxide Poisoning; 8 are open to participants now.
This study's planned enrollment of 108 is close to the median of 104 across 25 observational studies indexed under Carbon Monoxide Poisoning.
Browse Carbon Monoxide Poisoning studies →Azienda Ospedaliero Universitaria Maggiore della Carita is the lead sponsor of 55 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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Exclusion Criteria:
Patients with acute CO poisoning needing a hyperbaric oxygen treatment
Diagnostic Test: Microparticles research
Healthy controls i.e., healthy phisicians than will enter the hyperbaric oxygen therapy chamber to assist the patients
Diagnostic Test: Microparticles 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+).
Microparticles research
Quantify the number and the type of circulating microparticles in subjects after carbon monoxide poisoning.
Time frame: 2 years
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.
Time frame: 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.
Time frame: 45 days
Proteomic and transcriptomic analysis
Researche the type of microparticles with proteomic and transcriptomic analysis
Time frame: 2 years
Plan to share: 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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Azienda Ospedaliero Universitaria Maggiore della Carita