Head TraumaTCA-COAGNCT06246500
Severe Head Trauma: Coagulation and CT-Scan Aggravation.
An observational study of Head Trauma, run by Centre Hospitalier Annecy Genevois at 1 site in France.
Trial summary
Retrospective, multicenter cohort study describing the biological, radiological and clinical criteria of patients managed for isolated severe head trauma between January 2016 and December 2018. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head Trauma
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- 11 May 2021to 8 Jul 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patient data will be selected retrospectively and consecutively according to in and exclusion criteria. All patient admitted in emergency room between January 2016 and December 2018 severe head injury defined
Who may be able to join
- Adults
- Patients informed and did not object to the collection of their medical data for the study
- Patient admitted in Trauma center between January 2016 and December 2018 severe head injury defined by a Glasgow Coma Scale (GCS) < 9 AND/OR Abnormalities on the first brain CT-scan with pathological transcranial Doppler (Vd < 25 cm/s and IP > 1.25)
Who cannot join
- Abbreviated Injury Score (AIS) head and neck ≤ 3 AND/OR AIS out of head and neck > 3
- Taking drugs that interfere with hemostasis, such as anticoagulant or antiplatelet antiaggregants in preventive or curative doses;
- Patients under guardianship
- Patients still alive at the time of data collection AND opposed to the collection of their data
Trial locations and contacts
1 site in 1 country.
About this study
Retrospective, multicenter cohort study describing the biological, radiological and clinical criteria of patients managed for isolated severe head trauma between January 2016 and December 2018.
Read the detailed description
The objective of the study is to describe the evolution of CTscan lesions in patients with isolated Head Trauma between admission and re-evaluation after 24 hours.
- Conditions
- Head Trauma
- Being tested
- No intervention
- Medical subject headings
- Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe the evolution of CT scan lesions between admission and reassessment CT scan
Number of patient with an aggravation of lesions on CT scan
Measured: 24 hours
Secondary outcomes (6)
Mortality
Mortality rate
Measured: Day 28
Causes of death
Causes of death
Measured: Day 28
Describe the coagulation status on admission with severe head trauma trauma
Fibrinogen level values
Measured: 24 hours
Describe the coagulation status on admission with severe head trauma trauma
Platelet count values
Measured: 24 hours
Describe the coagulation status on admission with severe head trauma trauma
INR values
Measured: 24 hours
Describe the coagulation status on admission with severe head trauma trauma
ROTEM values
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start11 May 2021
- Primary completion8 Jul 2021
- Study completion8 Jul 2021
Why it stopped: Recruitment issue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head TraumaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Annecy Genevois
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06246500
- Sponsor's protocol ID
- 18-43
- Acronym
- TCA-COAG
- Status last verified
- Jul 2022
- First submitted
- 2 Mar 2021
- Last updated
- 7 Feb 2024
- 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 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Severe Head Trauma: Coagulation and CT-Scan Aggravation.
- ClinicalTrials.gov ID
- NCT06246500
- Acronym / sponsor ID
- TCA-COAG / 18-43
- Conditions
- Head Trauma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruitment issue
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Centre Hospitalier Annecy GenevoisUniversity, hospital or other
- Study start
- 11 May 2021 (actual)
- Primary completion
- 8 Jul 2021 (actual)
- Study completion
- 8 Jul 2021 (actual)
- First posted
- 7 Feb 2024 (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.
Retrospective, multicenter cohort study describing the biological, radiological and clinical criteria of patients managed for isolated severe head trauma between January 2016 and December 2018.
Detailed description
The objective of the study is to describe the evolution of CTscan lesions in patients with isolated Head Trauma between admission and re-evaluation after 24 hours.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient data will be selected retrospectively and consecutively according to in and exclusion criteria. All patient admitted in emergency room between January 2016 and December 2018 severe head injury defined
Key inclusion criteria (3 listed)
- Adults
- Patients informed and did not object to the collection of their medical data for the study
- Patient admitted in Trauma center between January 2016 and December 2018 severe head injury defined by a Glasgow Coma Scale (GCS) < 9 AND/OR Abnormalities on the first brain CT-scan with pathological transcranial Doppler (Vd < 25 cm/s and IP > 1.25)
Key exclusion criteria (4 listed)
- Abbreviated Injury Score (AIS) head and neck ≤ 3 AND/OR AIS out of head and neck > 3
- Taking drugs that interfere with hemostasis, such as anticoagulant or antiplatelet antiaggregants in preventive or curative doses;
- Patients under guardianship
- Patients still alive at the time of data collection AND opposed to the collection of their data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
Describe the evolution of CT scan lesions between admission and reassessment CT scan
Time frame: 24 hours
Number of patient with an aggravation of lesions on CT scan
6 secondary outcomes
Mortality
Time frame: Day 28
Causes of death
Time frame: Day 28
Describe the coagulation status on admission with severe head trauma trauma
Time frame: 24 hours
Describe the coagulation status on admission with severe head trauma trauma
Time frame: 24 hours
Describe the coagulation status on admission with severe head trauma trauma
Time frame: 24 hours
Describe the coagulation status on admission with severe head trauma trauma
Time frame: 24 hours
Results and safety
The study was stopped early (reason given: Recruitment issue). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Head Trauma, run by Centre Hospitalier Annecy Genevois 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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 7 Feb 2024. 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?
The study was stopped early (reason given: Recruitment issue). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe the evolution of CT scan lesions between admission and reassessment CT scan (time frame: 24 hours). 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 7 Feb 2024.