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

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

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.

Study Overview

• Status: Unknown
• Conditions: Length of Stay; Head Injury Other; Delayed Complications
• Intervention / Treatment: Other: Observation

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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Enrique Torres, PhD; Phone Number: 0034625579066; Email: enrique.torres@salud.madrid.org
• Study Contact Backup: Name: Blanca Villacañas, PhD; Email: blanca.villacanas@salud.madrid.org

Study Locations

• Spain
  • Madrid
    • San Lorenzo de El Escorial, Madrid, Spain, 28200
      • Hospital El Escorial

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.	Other: Observation; 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.	Other: Observation; 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.	Other: Observation; Check clinical status at different time intervals during 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hospital El Escorial
• Investigators: Study Chair: Francisco J Favá, PhD, Hospital El Escorial

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2019
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): March 1, 2020

Study Registration Dates

• First Submitted: May 29, 2019
• First Submitted That Met QC Criteria: May 30, 2019
• First Posted (Actual): May 31, 2019

Study Record Updates

• Last Update Posted (Actual): May 31, 2019
• Last Update Submitted That Met QC Criteria: May 30, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Craniocerebral Trauma
• Other Study ID Numbers: URGHESCHEADINJURY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No