Head Injury OtherHESCTCENCT03970421
Severity Factors and Needed Observation Time at ED of Patients Wih Head Injury
An observational study of Head Injury Other and Length of Stay, run by Hospital El Escorial at 1 site in Spain.
Trial summary
We know precisely which patients and when they should have an imaging test to evaluate a Head Injury (HI). But in those patients on anticoagulant and / or antiaggregant treatment we do not know the exact incidence of early and late hemorrhagic lesions, and there is no specific recommendation on how long they should… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Head Injury Other, Length of Stay, Delayed Complications
- What is being tested?
- Observation
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2019to Mar 2020
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients treated by HI in the Emergency Department (ED) and to whom an imaging test is performed (cranial CT scan)
Who may be able to join
- HI attended at ED
- Head CT performed as recommended by clinical guides
- Contact data available (phone number)
Who cannot join
- Patients not able for follow up (foreigners or tourists or whatsoever whom are not going to stay on the country for at least 3 months)
Trial locations and contacts
1 site in 1 country.
Blanca Villacañas, PhD contact
About this study
Official title: Demographic and Clinical Data Associated to Head Injury Severity on Adults Patients (Older Than 16yo), and Follow up for 90 Days to Check the Development of Associated Complications, Deciding the Optimal Observation Lapse at ED
We know precisely which patients and when they should have an imaging test to evaluate a Head Injury (HI). But in those patients on anticoagulant and / or antiaggregant treatment we do not know the exact incidence of early and late hemorrhagic lesions, and there is no specific recommendation on how long they should remain under observation in the emergency department if no initial lesions are evident. Our goal is to try to answer these two questions.
Read the detailed description
MATERIAL: Prospective study of patients treated of HI in the Emergency Department (ED) and to whom an image test is performed (cranial CT scan). Collection of demographic, clinical, analytical, image tests, and observation time in the emergency department (from admission to medical discharge)
METHODS: Separation of subjects included in the study in 4 cohorts: patients without anticoagulant and / or antiaggregant treatment; patients with antiplatelet therapy (ASA and / or clopidogrel); patients with anticoagulant treatment with acenocoumarol and INR <2; and patients on anticoagulant therapy with acenocoumarol and INR> = 2 or patients on treatment with direct thrombin inhibitors (dabigatran), or inhibitors of factor Xa (rivaroxaban, apixaban, edoxaban) or patients on treatment with low molecular weight heparins (LMWH) ) Follow-up through analysis of clinical history and telephone interview at 2, 7, 15, 30, 60 and 90 days.
Statistical analysis of the results.
- Conditions
- Head Injury Other, Length of Stay, Delayed Complications
- Being tested
- Observation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Check clinical status at different time intervals during 3 months
| Study group | Role | What they receive |
|---|---|---|
| patients without anticoagulant and / or antiplatelet treatment | Patients older than 16yo with no anticoagulant or antiplatelet treatment attended at ED because of Head Injury and with a Head CT performed. Receives: Other: Observation | |
| patients on antiplatelet therapy (ASA and / or clopidogrel | Patients older than 16yo on antiplatelet treatment attended at ED because of Head Injury and with a Head CT performed. Receives: Other: Observation | |
| patients on treatment with acenocoumarol and INR <2 | Patients older than 16yo on acenocumarol and with INR <2 attended at ED because of Head Injury and with a Head CT performed. Receives: Other: Observation | |
| Others | patients on anticoagulant therapy with acenocoumarol and INR> = 2 or patients on treatment with direct thrombin inhibitors (dabigatran), or inhibitors of factor Xa (rivaroxaban, apixaban, edoxaban) or patients on treatment with low molecular weight heparins (LMWH) attended at ED because of Head Injury and with a Head CT performed. Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity factors associated to head injury
Demographical, clinical, analitical, and neuroimaging data associated to severity of HI
Measured: 24 hours
Development of haemorragical complications during observation time
Finding of an haemorragical injury associated with the head injury during follow up
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study startJun 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head Injury OtherStudies 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
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital El Escorial
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francisco J Favá, PhD, Study chair, Hospital El Escorial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03970421
- Sponsor's protocol ID
- URGHESCHEADINJURY
- Acronym
- HESCTCE
- Status last verified
- May 2019
- First submitted
- 29 May 2019
- Last updated
- 31 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demographic and Clinical Data Associated to Head Injury Severity on Adults Patients (Older Than 16yo), and Follow up for 90 Days to Check the Development of Associated Complications, Deciding the Optimal Observation Lapse at ED
- ClinicalTrials.gov ID
- NCT03970421
- Acronym / sponsor ID
- HESCTCE / URGHESCHEADINJURY
- Conditions
- Head Injury Other, Length of Stay, Delayed Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hospital El EscorialUniversity, hospital or other
- Study start
- Jun 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 31 May 2019 (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.
We know precisely which patients and when they should have an imaging test to evaluate a Head Injury (HI). But in those patients on anticoagulant and / or antiaggregant treatment we do not know the exact incidence of early and late hemorrhagic lesions, and there is no specific recommendation on how long they should remain under observation in the emergency department if no initial lesions are evident. Our goal is to try to answer these two questions.
Detailed description
MATERIAL: Prospective study of patients treated of HI in the Emergency Department (ED) and to whom an image test is performed (cranial CT scan). Collection of demographic, clinical, analytical, image tests, and observation time in the emergency department (from admission to medical discharge)
METHODS: Separation of subjects included in the study in 4 cohorts: patients without anticoagulant and / or antiaggregant treatment; patients with antiplatelet therapy (ASA and / or clopidogrel); patients with anticoagulant treatment with acenocoumarol and INR <2; and patients on anticoagulant therapy with acenocoumarol and INR> = 2 or patients on treatment with direct thrombin inhibitors (dabigatran), or inhibitors of factor Xa (rivaroxaban, apixaban, edoxaban) or patients on treatment with low molecular weight heparins (LMWH) ) Follow-up through analysis of clinical history and telephone interview at 2, 7, 15, 30, 60 and 90 days.
Statistical analysis of the results.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| patients without anticoagulant and / or antiplatelet treatment | – | Other: ObservationPatients older than 16yo with no anticoagulant or antiplatelet treatment attended at ED because of Head Injury and with a Head CT performed. |
| patients on antiplatelet therapy (ASA and / or clopidogrel | – | Other: ObservationPatients older than 16yo on antiplatelet treatment attended at ED because of Head Injury and with a Head CT performed. |
| patients on treatment with acenocoumarol and INR <2 | – | Other: ObservationPatients older than 16yo on acenocumarol and with INR <2 attended at ED because of Head Injury and with a Head CT performed. |
| Others | – | Other: Observationpatients on anticoagulant therapy with acenocoumarol and INR> = 2 or patients on treatment with direct thrombin inhibitors (dabigatran), or inhibitors of factor Xa (rivaroxaban, apixaban, edoxaban) or patients on treatment with low molecular weight heparins (LMWH) attended at ED because of Head Injury and with a Head CT performed. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients treated by HI in the Emergency Department (ED) and to whom an imaging test is performed (cranial CT scan)
Key inclusion criteria (3 listed)
- HI attended at ED
- Head CT performed as recommended by clinical guides
- Contact data available (phone number)
Key exclusion criteria (1 listed)
- Patients not able for follow up (foreigners or tourists or whatsoever whom are not going to stay on the country for at least 3 months)
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 |
|---|---|---|
| ObservationCheck clinical status at different time intervals during 3 months | Other | Others, patients on antiplatelet therapy (ASA and / or clopidogrel, patients on treatment with acenocoumarol and INR <2, patients without anticoagulant and / or antiplatelet treatment |
Primary outcome
Severity factors associated to head injury
Time frame: 24 hours
Demographical, clinical, analitical, and neuroimaging data associated to severity of HI
Development of haemorragical complications during observation time
Time frame: 90 days
Finding of an haemorragical injury associated with the head injury during follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2019.
- Individual participant dataSharing planned: No
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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.
Blanca Villacañas, PhD contact
Francisco J Favá, PhD study chair
Hospital El Escorial
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 Injury Other and Length of Stay, run by Hospital El Escorial at 1 site in Spain.
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 1 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 31 May 2019. 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 Spain. 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 Enrique Torres, PhD (0034625579066, enrique.torres@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity factors associated to head injury (time frame: 24 hours). The study lists 2 primary outcomes in all. 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 31 May 2019.