Traumatic Brain Injury Associated Radiological DVT Incidence and Significance Study (TARDIS)
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|ClinicalTrials.gov Identifier: NCT03937947|
Recruitment Status : Recruiting
First Posted : May 6, 2019
Last Update Posted : August 22, 2019
Whilst deep vein thrombosis (DVT) is common following traumatic brain injury (TBI), optimal timing and safety of pharmacological prophylaxis is uncertain. Paradoxically the harm associated with the occurrence of is also unclear.
This study is an observational pilot that aims to define the incidence of proximal DVT in patients with moderate to severe TBI. It seeks prospectively to determine if there is an association between DVT and outcome. It also seeks to explore possible associations between the occurrence of DVT and the incidence of lung injury and/or ventilator associated pneumonia.
|Condition or disease|
|Traumatic Brain Injury Deep Vein Thrombosis Acute Lung Injury Ventilator Associated Pneumonia|
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Traumatic Brain Injury Associated Radiological Deep Venous Thrombosis Incidence and Significance|
|Estimated Study Start Date :||August 2019|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||October 2020|
- Incidence of proximal DVT by compression ultra sound [ Time Frame: within 72 hours of injury until day 10 post injury. ]Alternate day compression ultra sound
- Incidence of Acute Lung Injury [ Time Frame: Up to 10 days post injury ]PaO2:FiO2 <300 mmHg
- Incidence of Ventilator Associated Pneumonia [ Time Frame: Up to 10 days post injury ]Hospitals in Europe Link for Infection Control through Surveillance/European Centre for Disease Control and Prevention (HELICS/ESDC) criteria
- Ventilator days in ICU [ Time Frame: From day of injury until death whilst receiving ventilatory support or no longer requiring actively ventilation or respiratory support greater than the provision of continuous positive airways pressure (CPAP) via a tracheostomy, upto 6 months. ]Days or part off that respiratory support was provided via endotracheal tube or tracheostomy
- Length of Stay in ICU [ Time Frame: From day of injury until day of death or discharge from ICU to a step down unit providing level 1 care or lower, upto 6 months. ]Days or part off in ICU
- Hospital Length of Stay [ Time Frame: From day of injury until day of death or hospital discharge to a rehabilitation facility, nursing facility, or patient's home, assessed upto 6 months. ]Days or part of in hospital
- Modified Oxford Handicap Score [ Time Frame: To be completed on day 28 after injury, hospital discharge or death whichever occurs first. ]Functional Outcome- a score of 0 indicates no symptoms, 1 minor symptoms, 2 some restriction, 3 dependent, 4 fully dependent, and 5 death.
- Extended Glasgow Outcome Scale [ Time Frame: 6 months ]Functional Outcome - a score of 1 indicates death, 2 vegetative state, 3 lower severe disability, 4 upper severe disability, 5 lower moderate disability, 6 upper moderate disability, 7 lower good recovery , 8 upper good recovery.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03937947
|Contact: Jonathan K Rhodes, PhD, MB ChB||0131 537 firstname.lastname@example.org|
|Contact: Rosaleen Baruah, MB ChB||0131 537 email@example.com|
|Intensive Care Unit, Western General Hospital||Recruiting|
|Edinburgh, Midlothian, United Kingdom, EH42XU|
|Contact: Jonathan KJ Rhodes, PhD MB ChB 0131 537 1666 firstname.lastname@example.org|
|Contact: Rosaleen Baruah, MB ChB 0131 537 1666 email@example.com|