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Status unknownNCT05306951CT-HITUpdated Jun 1, 2022

Correct Timing of Head Imaging in Trauma

An observational study in Craniocerebral Trauma and Platelet Aggregation Inhibitors, sponsored by University of Padova. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-01.

Sponsored by University of Padova · Observational

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
3,200
Ages
18 Years and older
Sex
All
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Study 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.

Read the detailed description

Background Mild traumatic brain injury (mTBI) is one of the most common occurrences at the emergency departments in Italy and worldwide constituting major health and socioeconomic issue all over the world. mTBI is defined as a patient reporting a Glasgow Coma Scale (GSC) score of 14-15, disorientation, amnesia and loss of consciousness. On the other hand, the patient population treated with anticoagulant or antiplatelet drug therapy is increasing: this therapy is prescribed to prevent thromboembolic complications of atrial fibrillation, deep venous thrombosis, and surgically placed cardiac valves, especially in the elderly population. Numerous studies suggested that mostly aged patients or those with comorbidities with mTBI on anticoagulant or antiplatelet drug therapy have a higher risk of developing a haemorrhagic complication; but there is a lack of evidence for patients on new anticoagulants and second-generation antiplatelet drugs regarding a higher risk for intracranial haemorrhage (ICH), ICH progression, or death. Several international guidelines have been developed for the management of traumatic brain injury and they all recommended performing brain computed tomography (CT) for patients with head trauma taking oral anticoagulant agents even in absence of any neurological symptoms. Nevertheless, there is no agreement about the correct timing for performing a head CT scan, the duration of observation before discharge from ED and the necessity of repeating a second CT scan at distance. National Institute for Health and Care Excellence (NICE) guidelines 2014 recommend performing a CT scan within 8 hours of the injury for patients on anticoagulant therapy with mTBI and no other neurological symptoms, while European Federation of the Neurological Societies (EFNS) guidelines 2008 and New South Wales (NSW) guidelines 2011 recommend observation for 24 h and considering a second CT scan. A recent meta-analysis has collected 24 significant studies investigating the incidence of delayed intracranial haemorrhage in patients presenting with mTBI and anticoagulant or antiplatelet drug therapy: as far as anticoagulant drug therapy is concerned, only 2 studies regarding patients on double oral anticoagulation (DOAC) and 14 studies regarding patients on Vitamine K Antagonists (VKA) were identified. The incidence of delayed intracranial haemorrhage in both groups was the same (1.3%) and no difference was found between patients on DOAC who underwent a single CT scan and a repeated one after observation.

Main objective To describe patient characteristics and clinical management of patients with a head injury during antithrombotic therapy To assess the risk for serious events (intracranial haemorrhage, death for traumatic brain injury, need for surgery) in patients on anticoagulant therapy and/or antiplatelet drugs who underwent a head CT scan following head injury.

To identify potential predictors of outcome and assess potential differences between anticoagulation and antiplatelet therapy.

Study design Retrospective, single centre non-interventional study of all patients admitted to the emergency department (ED) of the University Hospital of Padova, Italy, from 01/01/2010 to 31/12/2020, for traumatic brain injury. All patients on anticoagulant therapy and antiplatelet drugs who underwent a head CT scan will be enrolled.

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Conditions studied

  • Craniocerebral Trauma
  • Platelet Aggregation Inhibitors

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03

In context

Craniocerebral Trauma

264 studies on the registry are indexed under Craniocerebral Trauma; 45 are open to participants now.

This study's planned enrollment of 3,200 is above the median of 200 across 115 observational studies indexed under Craniocerebral Trauma.

Browse Craniocerebral Trauma studies →

Lead sponsor

University of Padova is the lead sponsor of 214 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
3,200 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testComputed tomography

    Head computed tomography

    Also known as: Single computed tomography

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What researchers measure

Primary outcomes

  1. Diagnosis of intracranial hemorrhage

    Diagnosis of intracranial hemorrhage

    Time frame: 30 days

Secondary outcomes

  1. Need for surgery at 30-days-follow-up

    Need for surgery at 30-days-follow-up

    Time frame: 30 days

  2. Mortality for traumatic brain injury at 30-days-follow up

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

    Time frame: 30 days

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05306951
Collaborators
University Hospital Padova
Responsible party
Giulia Berti de Marinis (Principal investigator, University Hospital Padova) — Principal investigator
First posted
Apr 1, 2022
Start date
Mar 1, 2022
Primary completion
Dec 31, 2022 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
Jun 1, 2022

Study contacts

Giulia Berti De Marinis, MD
Contact
giulia.bertidemarinis@aopd.veneto.it
+390498212860

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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