Microparticles Blood Level in Acute Carbon Monoxide Poisoning

NCT05591300 | Recruiting

• 1 other identifier: AOCarita1
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

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 Two blood samples will be withdrawn from patients with acute carbon monoxide poisoning, one before and one after hyperbaric oxygen treatment.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

Conditions

Carbon Monoxide Poisoning

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Microparticles research

  Quantify the number and the type of circulating microparticles in subjects after carbon monoxide poisoning.

  2 years

Secondary Outcomes (3)

• Relationship between poisoning severity and circulating microparticles levels

  45 days

• Risk factors of delayed neurological syndrome development

  45 days

• Proteomic and transcriptomic analysis

  2 years

Study Arms (2)

Patients

Patients with acute CO poisoning needing a hyperbaric oxygen treatment

Diagnostic Test: Microparticles research

Healthy controls

Healthy controls i.e., healthy phisicians than will enter the hyperbaric oxygen therapy chamber to assist the patients

Diagnostic Test: Microparticles research

Interventions

Microparticles research DIAGNOSTIC_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+).

Healthy controls; Patients

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• Patient reject to consent

Sponsors & Collaborators

• Azienda Ospedaliero Universitaria Maggiore della Carita: lead
• Università degli Studi del Piemonte Orientale Amedeo Avogadro: collaborator

Study Sites (1)

AOU Maggiore della Carità

Novara, 28100, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

3 ml blood in sodium citrate before and after hyperbaric treatment will be performed.

MeSH Terms

Conditions

Carbon Monoxide Poisoning

Condition Hierarchy (Ancestors)

Gas Poisoning; Poisoning; Chemically-Induced Disorders

Study Officials

• Rosanna Vaschetto, MD, PhD

  University of Eastern Piedmont

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosanna Vaschetto

CONTACT

+39 3342724811; rosanna.vaschetto@med.uniupo.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 45 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: October 24, 2022
• Study Start: November 15, 2022
• Primary Completion: April 1, 2025
• Study Completion: November 1, 2025
• Last Updated: November 14, 2024

Record last verified: 2024-11

Locations

IT (1)