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

NCT03970421 | Unknown

• 1 other identifier: URGHESCHEADINJURY
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Head Injury Other; Length of Stay; Delayed Complications

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

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.

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.

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.

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.

Other: Observation

Interventions

Observation OTHER

Check clinical status at different time intervals during 3 months

Others; patients on antiplatelet therapy (ASA and / or clopidogrel; patients on treatment with acenocoumarol and INR <2; patients without anticoagulant and / or antiplatelet treatment

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated by HI in the Emergency Department (ED) and to whom an imaging test is performed (cranial CT scan)

You may qualify if:

• HI attended at ED
• Head CT performed as recommended by clinical guides
• Contact data available (phone number)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hospital El Escorial: lead

Study Sites (1)

Hospital EL Escorial

El Escorial, Madrid, 28200, Spain

Location

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Francisco J Favá, PhD

  Hospital El Escorial

  STUDY CHAIR

Central Study Contacts

Enrique Torres, PhD

CONTACT

0034625579066; enrique.torres@salud.madrid.org

Blanca Villacañas, PhD

CONTACT

blanca.villacanas@salud.madrid.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: May 31, 2019
• Study Start: June 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: March 1, 2020
• Last Updated: May 31, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)