Severity Factors and Needed Observation Time at ED of Patients Wih Head Injury

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Head Injury Other, Length of Stay, Delayed Complications

Intervention / Treatment
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* Other: Observation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HI attended at ED Head CT performed as recommended by clinical guides Contact data available (phone number) Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients without anticoagulant and / or antiplatelet treatment<br>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<br>* Check clinical status at different time intervals during 3 months<br>|
| patients on antiplatelet therapy (ASA and / or clopidogrel<br>Patients older than 16yo on antiplatelet treatment attended at ED because of Head Injury and with a Head CT performed. | Other: Observation<br>* Check clinical status at different time intervals during 3 months<br>|
| patients on treatment with acenocoumarol and INR <2<br>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<br>* Check clinical status at different time intervals during 3 months<br>|
| Others<br>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<br>* Check clinical status at different time intervals during 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity factors associated to head injury | Demographical, clinical, analitical, and neuroimaging data associated to severity of HI | 24 hours | 
| Development of haemorragical complications during observation time | Finding of an haemorragical injury associated with the head injury during follow up | 90 days |