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

Length of Stay Clinical Trial

— HESCTCE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03970421
• Other study ID #: URGHESCHEADINJURY
• Status: Not yet recruiting
• Start date: June 2019
• Est. completion date: March 2020

Study information

• Verified date: May 2019
• Source: Hospital El Escorial
• Contact: Enrique Torres, PhD
• Phone: 0034625579066
• Email: enrique.torres[@]salud.madrid.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: March 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Craniocerebral Trauma
• Delayed Complications
• Head Injury Other
• Length of Stay
• Wounds and Injuries

Intervention

Other:
• Observation
Check clinical status at different time intervals during 3 months

Locations

Country	Name	City	State
Spain	Hospital EL Escorial	San Lorenzo de El Escorial	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital El Escorial

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity factors associated to head injury	Demographical, clinical, analitical, and neuroimaging data associated to severity of HI	24 hours
Primary	Development of haemorragical complications during observation time	Finding of an haemorragical injury associated with the head injury during follow up	90 days