NCT04597879

Brief Summary

Severe brain injury (SBI) is one of the world's leading causes of death and disability in young adults, but its peripheral vascular consequences in humans are poorly understood. This prospective, monocentric, pathophysiological study aims to investigate differences in vasoreactivity in the anterior aspect of the contralateral forearm at the most injured cerebral hemisphere between patients with severe head trauma and patients with severe trauma without associated brain injury matched on sex and age (+/- 5 years).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2021

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

November 3, 2022

Status Verified

October 1, 2022

Enrollment Period

14 days

First QC Date

October 9, 2020

Last Update Submit

November 2, 2022

Conditions

Severe Traumatic Brain InjuryTrauma

Keywords

Brain traumaSevere traumatic brain injuryMicrocirculationSpecklePost-occlusive reactive hyperaemia

Outcome Measures

Primary Outcomes (1)

  • Post-occlusive hyperaemia

    Maximum amplitude expressed as percentage of vasodilation and area under the curve: AUC

    0-60 days

Secondary Outcomes (9)

  • Post-occlusive hyperaemia with local anesthesia

    0-60 days

  • Current-Induced Hyperaemia

    0-60 days

  • Current-Induced Hyperaemia with local anesthesia

    0-60 days

  • Local thermal hyperaemia

    0-60 days

  • Local thermal hyperaemia with local anesthesia

    0-60 days

  • +4 more secondary outcomes

Study Arms (3)

Severe traumatic brain injury

Severe trauma without brain trauma

Healthy controls

Eligibility Criteria

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

* Patients admitted for severe head trauma or severe trauma without associated severe head trauma in intensive care at Grenoble University Hospital. * Healthy volunteers recruited through classified ads

You may qualify if:

  • Healthy volunteers :
  • Men and women, over 18 years of age
  • Affiliation to a social security scheme
  • Signed Consent
  • Patients with Severe Brain Injury :
  • Male and female, over 18 years of age
  • Isolated severe brain injury, defined by an initial Glasgow score less than or equal to 8.
  • Affiliation to a social security scheme
  • Signed informed consent
  • Severe traumatized patients without associated severe brain injury:
  • men and women, over 18 years of age
  • severe trauma, defined by an Injury Severity Score (ISS) ≥ 16.
  • absence of associated severe brain injury, defined by an initial Glasgow score less than or equal to 8.
  • affiliation to or beneficiary of a social security scheme
  • signed informed consent

You may not qualify if:

  • Hypersensitivity to lidocaine and/or prilocaine or to amide type local anesthetics or to any of the excipients of the cream.
  • History of axillary lymph node dissection, trauma or axillary surgery
  • Prohibited treatments and procedures :
  • In patients with head trauma: ongoing treatment with systemic vasodilators (calcium channel blocker, milrinone).
  • In healthy volunteers: no treatment will be authorized other than paracetamol, hormone supplementation (contraceptive pill, hormone therapy, thyroid hormones).
  • Pregnant, parturient or breastfeeding women
  • Person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure,
  • Subject having exceeded the annual compensation threshold for testing
  • Subject cannot be contacted in case of emergency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Grenoble, 38700, France

RECRUITING

MeSH Terms

Conditions

Brain Injuries, TraumaticWounds and Injuries

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous System

Study Officials

  • Jean-Luc Cracowksi, Pr

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Luc Cracowski, Pr

CONTACT

0476767856JLCracowski@chu-grenoble.fr

Manon Gabin, Intern

CONTACT

0476767575mgabin@chu-grenoble.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2020

First Posted

October 22, 2020

Study Start

August 1, 2021

Primary Completion

August 15, 2021

Study Completion

March 31, 2023

Last Updated

November 3, 2022

Record last verified: 2022-10

Locations

FR(1)