COMPs: Microparticles Blood Level in Acute Carbon Monoxide Poisoning

Sponsor
Azienda Ospedaliero Universitaria Maggiore della Carita (Other)
Overall Status
Recruiting
CT.gov ID
NCT05591300
Collaborator
Università degli Studi del Piemonte Orientale "Amedeo Avogadro" (Other)
108
1
36
3

Study Details

Study Description

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 Two blood samples will be withdrawn from patients with acute carbon monoxide poisoning, one before and one after hyperbaric oxygen treatment.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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
108 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Microparticles Blood Level in Acute Carbon Monoxide Poisoning
Actual Study Start Date :
Nov 15, 2022
Anticipated Primary Completion Date :
Nov 15, 2024
Anticipated Study Completion Date :
Nov 15, 2025

Arms and Interventions

Arm 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+).

Outcome Measures

Primary Outcome Measures

  1. Microparticles research [2 years]

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

Secondary Outcome Measures

  1. Relationship between poisoning severity and circulating microparticles levels [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.

  2. Risk factors of delayed neurological syndrome development [45 days]

    Research of risk factors of delayed neurological syndrome development and follow up with test of Pfeiffer.

  3. Proteomic and transcriptomic analysis [2 years]

    Researche the type of microparticles with proteomic and transcriptomic analysis

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Age > 18 years

  • Acute carbon monoxide poisoning

  • Need for treatment with hyperbaric oxygen

Exclusion Criteria:
  • Patient reject to consent

Contacts and Locations

Locations

Site City State Country Postal Code
1 AOU Maggiore della Carità Novara Italy 28100

Sponsors and Collaborators

  • Azienda Ospedaliero Universitaria Maggiore della Carita
  • Università degli Studi del Piemonte Orientale "Amedeo Avogadro"

Investigators

  • Principal Investigator: Rosanna Vaschetto, MD, PhD, University of Eastern Piedmont

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rosanna Vaschetto, MD, PhD, Professor, Azienda Ospedaliero Universitaria Maggiore della Carita
ClinicalTrials.gov Identifier:
NCT05591300
Other Study ID Numbers:
  • AOCarita1
First Posted:
Oct 24, 2022
Last Update Posted:
Feb 1, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Rosanna Vaschetto, MD, PhD, Professor, Azienda Ospedaliero Universitaria Maggiore della Carita
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 1, 2023