NCT04201860

Brief Summary

The aim of the study was to investigate the possible relationship about blood gas and bleeding disorders in healthy volunteers of blasters and no blasters groups of the Italian National Mountain and Cave Rescue who handled nitrogen compounds and nitroglycerine and then they were exposed to combustion products from an accidental uncontrolled detonation of micro-charges during a cave unblocking procedure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 12, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 17, 2019

Completed
Last Updated

February 26, 2020

Status Verified

February 1, 2020

Enrollment Period

1.9 years

First QC Date

December 12, 2019

Last Update Submit

February 24, 2020

Conditions

Disorder of Blood GasBleeding Disorder

Keywords

Arterial blood gasCoagulationNitrogen compounds

Outcome Measures

Primary Outcomes (2)

  • Change from baseline arterial blood gases analysis at 2 hours

    Under aseptic conditions, a puncture of radial artery was performed: one mL was tested for the blood gases analysis, by using i-STAT analyser.

    10 minutes before going in to the cave and two hours after the volunteers come out from the cave

  • Change from baseline haemostasis analysis at 2 hours

    Under aseptic conditions, a venipuncture was performed: three mL of blood sample were used for the haemostasis measure, by using Rotational Thromboelastometry

    10 minutes before going in to the cave and two hours after the volunteers come out from the cave

Secondary Outcomes (4)

  • Change from Baseline heart rate at 2 hours

    10 minutes before going in to the cave and two hours after the volunteers come out from the cave

  • Change from baseline arterial blood pressure at 2 hours

    10 minutes before going in to the cave and two hours after the volunteers come out from the cave

  • Change from baseline pulse oxymetry at 2 hours

    10 minutes before going in to the cave and two hours after the volunteers come out from the cave

  • Change from baseline epitympanic temperature at 2 hours

    10 minutes before going in to the cave and two hours after the volunteers come out from the cave

Study Arms (2)

Blasters group

The volunteers of the blasters group of Italian Mountain and Cave Rescue handled explosive with nitrogen compounds and nitroglycerin of micro-charges, before the accidental uncontrolled detonation.

Diagnostic Test: Arterial blood gas analyses and haemostasis measures

Not blasters group

The volunteers of the blasters group of Italian Mountain and Cave Rescue did not handle explosive with nitrogen compounds and nitroglycerin of micro-charges, before the accidental uncontrolled detonation.

Diagnostic Test: Arterial blood gas analyses and haemostasis measures

Interventions

Arterial blood gas analyses and haemostasis measuresDIAGNOSTIC_TEST

Under aseptic conditions, a puncture of radial artery was performed: three mL of the arterial blood sample were used for the haemostasis measure, while one mL was tested for the blood gases analysis.

Blasters groupNot blasters group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy volunteers of Blasters and No Blasters Group of the Italian National Mountain and Cave Rescue

You may qualify if:

  • Healthy volunteers of Italian National Mountain and Cave Rescue

You may not qualify if:

  • gas exchange disorders
  • quantitative abnormalities of coagulation assessment
  • qualitative abnormalities of coagulation assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barbara Pizzi

Avezzano, 67051, Italy

Location

MeSH Terms

Conditions

Hemostatic DisordersThrombosis

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic DiseasesEmbolism and Thrombosis

Study Officials

  • Emiliano Petrucci, MD

    San Salvatore Academic Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 12, 2019

First Posted

December 17, 2019

Study Start

December 12, 2016

Primary Completion

November 12, 2018

Study Completion

December 12, 2019

Last Updated

February 26, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)