Severe Traumatic Brain InjuryMicroTCNCT04597879
Impact of Severe Brain Injury on Neuro-vascular and Endothelial Regulation of Peripheral Microcirculation.
An observational study of Severe Traumatic Brain Injury and Trauma, run by University Hospital, Grenoble at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Severe Traumatic Brain Injury, Trauma
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2021to 31 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- Subject in a period of exclusion from another study,
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital
Grenoble, 38700
Jean-Luc Cracowski, Pr, 0476767856 ext. 0033, JLCracowski@chu-grenoble.fr
Manon Gabin, Intern, 0476767575, mgabin@chu-grenoble.fr
About this study
Official title: Study of the Impact of Severe Brain Injury on the Neuro-vascular and Endothelial Regulation of Peripheral Microcirculation.
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).
Read the detailed description
Severe brain injury (SBI) is one of the world's leading causes of death and disability in young adults.
Its impact on cerebral vascularization is well known. At the systemic level, it induces transient dysfunctions that can develop into severe failures, even in cases of isolated SBI. Studies on a mouse model of SBI show alterations in peripheral vascular reactivity that persist over time and are linked to endothelial dysfunction, the mechanism of which is a decoupling of endothelial NO synthase in a context of systemic inflammation. However, no data are available regarding the peripheral vascular consequences of SBI in humans.
The main objective of this prospective, monocentric, pathophysiological study is to determine whether the postocclusive hyperaemic response at the anterior surface of the contralateral forearm to the most injured cerebral hemisphere differs between patients with severe brain injury and patients with severe trauma without associated head injury matched on sex and age (+/- 5 years), by studying the amplitude of post-occlusive hyperaemia (maximum amplitude expressed as percentage of vasodilatation and area under the curve : AUC) as a function of the group.
- Conditions
- Severe Traumatic Brain Injury, Trauma
- Keywords
- Brain trauma, Severe traumatic brain injury, Microcirculation, Speckle, Post-occlusive reactive hyperaemia
- Medical subject headings
- Brain Injuries, Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Severe traumatic brain injury | Not described | |
| Severe trauma without brain trauma | Not described | |
| Healthy controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-occlusive hyperaemia
Maximum amplitude expressed as percentage of vasodilation and area under the curve: AUC
Measured: 0-60 days
Secondary outcomes (9)
Post-occlusive hyperaemia with local anesthesia
Maximum amplitude expressed as percentage of vasodilation and area under the curve: AUC
Measured: 0-60 days
Current-Induced Hyperaemia
Area under the curve expressed as a percentage of the baseline.
Measured: 0-60 days
Current-Induced Hyperaemia with local anesthesia
Area under the curve expressed as a percentage of the baseline.
Measured: 0-60 days
Local thermal hyperaemia
Maximum amplitude of the initial peak expressed as a percentage of the baseline and area under the curve of the delayed plateau.
Measured: 0-60 days
Local thermal hyperaemia with local anesthesia
Maximum amplitude of the initial peak expressed as a percentage of the baseline and area under the curve of the delayed plateau.
Measured: 0-60 days
Flow amplitude after local cooling
Amplitude of initial vasoconstriction averaged over 1 min around the lowest flow value during the first 5 minutes.
Measured: 0-60 days
Transient venous post-compression hyperaemia
Area under the curve and percentage change from baseline.
Measured: 0-60 days
Study of vasoreactivity in patients with severe brain injury
Extent of post-occlusive hyperaemia, current-induced hyperaemia, thermal hyperaemia and cold response in patients with severe brain injury.
Measured: 0-60 days
Study of vasoreactivity in healthy subjects
Description of the magnitude of post-occlusive hyperaemia, current-induced hyperaemia, thermal hyperaemia and cold response in healthy subjects.
Measured: Study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Aug 2021
- Primary completion15 Aug 2021
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Luc Cracowksi, Pr, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04597879
- Sponsor's protocol ID
- 2020-A00183-36
- Other IDs
- 38RC20.014
- Acronym
- MicroTC
- Status last verified
- Oct 2022
- First submitted
- 9 Oct 2020
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Impact of Severe Brain Injury on the Neuro-vascular and Endothelial Regulation of Peripheral Microcirculation.
- ClinicalTrials.gov ID
- NCT04597879
- Acronym / sponsor ID
- MicroTC / 2020-A00183-36
- Conditions
- Severe Traumatic Brain Injury, Trauma
- Keywords
- Brain trauma, Severe traumatic brain injury, Microcirculation, Speckle, Post-occlusive reactive hyperaemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 15 Aug 2021 (actual)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Severe brain injury (SBI) is one of the world's leading causes of death and disability in young adults.
Its impact on cerebral vascularization is well known. At the systemic level, it induces transient dysfunctions that can develop into severe failures, even in cases of isolated SBI. Studies on a mouse model of SBI show alterations in peripheral vascular reactivity that persist over time and are linked to endothelial dysfunction, the mechanism of which is a decoupling of endothelial NO synthase in a context of systemic inflammation. However, no data are available regarding the peripheral vascular consequences of SBI in humans.
The main objective of this prospective, monocentric, pathophysiological study is to determine whether the postocclusive hyperaemic response at the anterior surface of the contralateral forearm to the most injured cerebral hemisphere differs between patients with severe brain injury and patients with severe trauma without associated head injury matched on sex and age (+/- 5 years), by studying the amplitude of post-occlusive hyperaemia (maximum amplitude expressed as percentage of vasodilatation and area under the curve : AUC) as a function of the group.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Severe traumatic brain injury | – | – |
| Severe trauma without brain trauma | – | – |
| Healthy controls | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (15 listed)
- Men and women, over 18 years of age
- Affiliation to a social security scheme
- Signed Consent
- Male and female, over 18 years of age
- Isolated severe brain injury, defined by an initial Glasgow score less than or equal to 8.
Key exclusion criteria (10 listed)
- 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 :
- Pregnant, parturient or breastfeeding women
- Subject in a period of exclusion from another study,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Post-occlusive hyperaemia
Time frame: 0-60 days
Maximum amplitude expressed as percentage of vasodilation and area under the curve: AUC
9 secondary outcomes
Post-occlusive hyperaemia with local anesthesia
Time frame: 0-60 days
Current-Induced Hyperaemia
Time frame: 0-60 days
Current-Induced Hyperaemia with local anesthesia
Time frame: 0-60 days
Local thermal hyperaemia
Time frame: 0-60 days
Local thermal hyperaemia with local anesthesia
Time frame: 0-60 days
Flow amplitude after local cooling
Time frame: 0-60 days
Transient venous post-compression hyperaemia
Time frame: 0-60 days
Study of vasoreactivity in patients with severe brain injury
Time frame: 0-60 days
Study of vasoreactivity in healthy subjects
Time frame: Study visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Luc Cracowksi, Pr principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Traumatic Brain Injury and Trauma, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Luc Cracowski, Pr (0476767856 ext. 0033, JLCracowski@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-occlusive hyperaemia (time frame: 0-60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.