Microparticles Blood Level in Acute Carbon Monoxide Poisoning (COMPs)

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 Two blood samples will be withdrawn from patients with acute carbon monoxide poisoning, one before and one after hyperbaric oxygen treatment.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

Study Overview

• Status: Recruiting
• Conditions: Carbon Monoxide Poisoning
• Intervention / Treatment: Diagnostic test: Microparticles research

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 Type: Observational
• Enrollment (Estimated): 108

Contacts and Locations

• Study Contact: Name: Rosanna Vaschetto; Phone Number: +39 3342724811; Email: rosanna.vaschetto@med.uniupo.it

Study Locations

• Italy
  • Novara, Italy, 28100
    • Recruiting
    • AOU Maggiore della Carità
    • Sub-Investigator: Carlo Olivieri, MD
    • Sub-Investigator: Andrea Giovanniello, MD
    • Sub-Investigator: Davide Colombo, MD
    • Sub-Investigator: Racca Fabrizio, MD
    • Sub-Investigator: Puggioni Angelo, MD
    • Sub-Investigator: Zorzi Stefano, MD
    • Contact: Rosanna Vaschetto; Phone Number: 3342724811; Email: rosanna.vaschetto@med.uniupo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Patient reject to consent

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients; Patients with acute CO poisoning needing a hyperbaric oxygen treatment	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+).
Healthy controls; 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+).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microparticles research	Quantify the number and the type of circulating microparticles in subjects after carbon monoxide poisoning.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	45 days
Proteomic and transcriptomic analysis	Researche the type of microparticles with proteomic and transcriptomic analysis	2 years

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita
• Collaborators: Università degli Studi del Piemonte Orientale Amedeo Avogadro
• Investigators: Principal Investigator: Rosanna Vaschetto, MD, PhD, University of Eastern Piedmont

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2022
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: October 19, 2022
• First Submitted That Met QC Criteria: October 19, 2022
• First Posted (Actual): October 24, 2022

Study Record Updates

• Last Update Posted (Estimated): November 14, 2024
• Last Update Submitted That Met QC Criteria: November 13, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Hyperbaric Oxygen; Microparticles; CO; Microvesicles; Carbon monoxide poisoning; Carbon monoxide intoxication; Delayed neurological syndrome
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Gas Poisoning; Poisoning; Carbon Monoxide Poisoning
• Other Study ID Numbers: AOCarita1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No