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Correct Timing of Head Imaging in Trauma (CT-HIT)

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ClinicalTrials.gov Identifier: NCT05306951
Recruitment Status : Recruiting
First Posted : April 1, 2022
Last Update Posted : June 1, 2022
Sponsor:
Collaborator:
University Hospital Padova
Information provided by (Responsible Party):
Giulia Berti de Marinis, University Hospital Padova

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.


Condition or disease Intervention/treatment
Craniocerebral Trauma Platelet Aggregation Inhibitors Diagnostic Test: Computed tomography

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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Study Type : Observational
Estimated Enrollment : 3200 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Correct Timing of Head Imaging in Trauma
Actual Study Start Date : March 1, 2022
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Computed tomography
    Head computed tomography
    Other Name: Single computed tomography


Primary Outcome Measures :
  1. Diagnosis of intracranial hemorrhage [ Time Frame: 30 days ]
    Diagnosis of intracranial hemorrhage


Secondary Outcome Measures :
  1. Need for surgery at 30-days-follow-up [ Time Frame: 30 days ]
    Need for surgery at 30-days-follow-up

  2. Mortality for traumatic brain injury at 30-days-follow up [ Time Frame: 30 days ]
    Mortality for traumatic brain injury at 30-days-follow up



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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
Criteria

Inclusion Criteria:

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05306951


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

Locations
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Italy
Azienda Ospedale Università Padova Recruiting
Padova, PD, Italy, 35128
Contact: Giulia Berti De Marinis, MD    +390498212860    giulia.bertidemarinis@aopd.veneto.it   
Sponsors and Collaborators
University of Padova
University Hospital Padova
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Responsible Party: Giulia Berti de Marinis, Principal investigator, University Hospital Padova
ClinicalTrials.gov Identifier: NCT05306951    
Other Study ID Numbers: PDED0121
First Posted: April 1, 2022    Key Record Dates
Last Update Posted: June 1, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Craniocerebral Trauma
Wounds and Injuries
Trauma, Nervous System
Nervous System Diseases