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

NCT ID: NCT03970421

Last Updated: 2019-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-30

Study Completion Date

2020-03-31

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.

Conditions

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Head Injury Other Length of Stay Delayed Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Observation

Intervention Type OTHER

Check clinical status at different time intervals during 3 months

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.

Observation

Intervention Type OTHER

Check clinical status at different time intervals during 3 months

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.

Observation

Intervention Type OTHER

Check clinical status at different time intervals during 3 months

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.

Observation

Intervention Type OTHER

Check clinical status at different time intervals during 3 months

Interventions

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Observation

Check clinical status at different time intervals during 3 months

Intervention Type OTHER

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)
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital El Escorial

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francisco J Favá, PhD

Role: STUDY_CHAIR

Hospital El Escorial

Locations

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Hospital EL Escorial

El Escorial, Madrid, Spain

Site Status

Countries

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Spain

Central Contacts

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Enrique Torres, PhD

Role: CONTACT

Phone: 0034625579066

Email: [email protected]

Blanca Villacañas, PhD

Role: CONTACT

Email: [email protected]

Other Identifiers

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URGHESCHEADINJURY

Identifier Type: -

Identifier Source: org_study_id