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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03970421
Acronym
HESCTCE
Enrollment
300
Registered
2019-05-31
Start date
2019-06-30
Completion date
2020-03-31
Last updated
2019-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delayed Complications, Head Injury Other, Length of Stay

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.

Interventions

OTHERObservation

Check clinical status at different time intervals during 3 months

Sponsors

Hospital El Escorial
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Severity factors associated to head injury24 hoursDemographical, clinical, analitical, and neuroimaging data associated to severity of HI
Development of haemorragical complications during observation time90 daysFinding of an haemorragical injury associated with the head injury during follow up

Countries

Spain

Contacts

Primary ContactEnrique Torres, PhD
enrique.torres@salud.madrid.org0034625579066
Backup ContactBlanca Villacañas, PhD
blanca.villacanas@salud.madrid.org

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026