An observational study in Head Injury Other, Length of Stay and Delayed Complications, sponsored by Hospital El Escorial. Status unknown at 1 site in Spain. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2019-05-31.
Sponsored by Hospital El Escorial · Observational
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.
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.
253 studies on the registry are indexed under Craniocerebral Trauma; 45 are open to participants now.
This study's planned enrollment of 300 is above the median of 180 across 108 observational studies indexed under Craniocerebral Trauma.
Browse Craniocerebral Trauma studies →Hospital El Escorial is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients treated by HI in the Emergency Department (ED) and to whom an imaging test is performed (cranial CT scan)
Exclusion Criteria:
Patients older than 16yo with no anticoagulant or antiplatelet treatment attended at ED because of Head Injury and with a Head CT performed.
Other: Observation
Patients older than 16yo on antiplatelet treatment attended at ED because of Head Injury and with a Head CT performed.
Other: Observation
Patients older than 16yo on acenocumarol and with INR \<2 attended at ED because of Head Injury and with a Head CT performed.
Other: Observation
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.
Other: Observation
Check clinical status at different time intervals during 3 months
Severity factors associated to head injury
Demographical, clinical, analitical, and neuroimaging data associated to severity of HI
Time frame: 24 hours
Development of haemorragical complications during observation time
Finding of an haemorragical injury associated with the head injury during follow up
Time frame: 90 days
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.