Correct Timing of Head Imaging in Trauma

NCT05306951 | Unknown

• 1 other identifier: PDED0121
• Study Type: observational
• Target: 3,200
• Locations: 1 country
• Sites: 1

Brief Summary

The aims of this retrospective and monocentric observational study are: to describe patient characteristics and clinical management of patients with traumatic brain injury taking antiplatelet and/or anticoagulation drugs; to estimate the proportion of patients who suffer an adverse outcome; to assess the risk for serious events (intracranial haemorrhage, in-hospital mortality, need for surgery); to identify potential predictors of outcome and assess potential differences between anticoagulation and antiplatelet therapy. All patients with mild brain injury and anticoagulant or antiplatelet therapy who underwent a head computed tomography (CT) scan admitted to the emergency department (ED) of the University Hospital of Padova, Italy, from 01/01/2010 to 31/12/2020.

Conditions

Craniocerebral Trauma; Platelet Aggregation Inhibitors

Outcome Measures

Primary Outcomes (1)

• Diagnosis of intracranial hemorrhage

  Diagnosis of intracranial hemorrhage

  30 days

Secondary Outcomes (2)

• Need for surgery at 30-days-follow-up

  30 days

• Mortality for traumatic brain injury at 30-days-follow up

  30 days

Interventions

Computed tomography DIAGNOSTIC_TEST

Head computed tomography

Also known as: Single computed tomography

Eligibility Criteria

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

Study Population

Patients with mild brain injury and anticoagulant or antiplatelet therapy who underwent a head CT scan and have been admitted to the Emergency Department

You may qualify if:

• A head computed tomography (CT) scan following head trauma
• Age ≥18 Years
• Anticoagulant and/or antiplatelet therapy

You may not qualify if:

• moderate or severe brain injury (GCS ≤ 13 in the initial assessment in the ED)
• concomitant severe thoracic trauma with hypoxia (satO2 \< 90% room air)
• active bleeding and/or hemodynamic instability
• intracranial haemorrhage with features suggesting spontaneous bleeding

Sponsors & Collaborators

• University of Padova: lead
• University Hospital Padova: collaborator

Study Sites (1)

Azienda Ospedale Università Padova

Padua, PD, 35128, Italy

RECRUITING

MeSH Terms

Conditions

Craniocerebral Trauma

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Central Study Contacts

Giulia Berti De Marinis, MD

CONTACT

+390498212860; giulia.bertidemarinis@aopd.veneto.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 1, 2022
• Study Start: March 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: June 1, 2022

Record last verified: 2022-05

Locations

IT (1)