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

• Conditions: Head Injury Other; Delayed Complications; Length of Stay
• Interventions: Other: Observation

• Registration Number: NCT03970421
• Lead Sponsor: Hospital El Escorial

Brief 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 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 Timeline

• Status Verified: 2019-05
• Study First Submitted: 2019-05-29
• Study First Submitted QC: 2019-05-30
• Last Update Submitted: 2019-05-30
• Study First Posted: 2019-05-31
• Last Update Posted: 2019-05-31
• Study Start: 2019-06
• Primary Completion: 2019-12
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients without anticoagulant and / or antiplatelet treatment	Observation	Patients 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	Observation	Patients 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	Observation	Patients older than 16yo on acenocumarol and with INR \<2 attended at ED because of Head Injury and with a Head CT performed.
Others	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Hospital EL Escorial; 🇪🇸 San Lorenzo de El Escorial, Madrid, Spain