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Craniocerebral TraumaCT-HITNCT05306951

Correct Timing of Head Imaging in Trauma

An observational study of Craniocerebral Trauma and Platelet Aggregation Inhibitors, run by University of Padova at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Computed tomography
How many people
3,200 participants
Where
1 siteItaly
Study dates
1 Mar 2022to 31 Dec 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Giulia Berti De Marinis, MD contact

+390498212860

giulia.bertidemarinis@aopd.veneto.it

Italy1 site, 1 recruiting
  • Azienda Ospedale Università Padova

    Padova, PD, 35128

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

    Recruiting

Other trials in Italy

About this study

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.

Medical subject headings
Craniocerebral Trauma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Computed tomographyDiagnostic test

    Also called Single computed tomography

    Head computed tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diagnosis of intracranial hemorrhage

    Diagnosis of intracranial hemorrhage

    Measured: 30 days

Secondary outcomes (2)
  1. Need for surgery at 30-days-follow-up

    Need for surgery at 30-days-follow-up

    Measured: 30 days

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

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

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2022
  2. Study start1 Mar 2022
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
3,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05306951
Sponsor's protocol ID
PDED0121
Acronym
CT-HIT
Status last verified
May 2022
First submitted
23 Mar 2022
Last updated
1 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Craniocerebral Trauma and Platelet Aggregation Inhibitors, run by University of Padova at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Giulia Berti De Marinis, MD (+390498212860, giulia.bertidemarinis@aopd.veneto.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnosis of intracranial hemorrhage (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.

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