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Traumatic Brain Injury Associated Radiological DVT Incidence and Significance Study (TARDIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03937947
Recruitment Status : Recruiting
First Posted : May 6, 2019
Last Update Posted : August 22, 2019
Sponsor:
Collaborator:
Edinburgh Clinical Trials Unit
Information provided by (Responsible Party):
Jonathan Rhodes, NHS Lothian

Brief Summary:

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

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
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





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Incidence of Acute Lung Injury [ Time Frame: Up to 10 days post injury ]
    PaO2:FiO2 <300 mmHg

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  7. 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.



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adults with moderate to severe TBI requiring critical care support.
Criteria

Inclusion Criteria:

  1. Age ≥ 16 years
  2. Admission to critical care
  3. moderate/severe, non-penetrating traumatic brain injury
  4. Abnormal brain CT Scan
  5. Post resuscitation Glasgow coma score (GCS) ≤12, or GCS motor component ≤5
  6. Able to complete consent and first USS within 72 hours of injury

Exclusion Criteria:

  1. Normal brain CT scan
  2. Unlikely to survive for the next 24 hours in the opinion of the ICU Consultant or Consultant Neurosurgeon treating the patient
  3. Contra indication to normal prophylactic measures, including heparin, were indicated
  4. Known blood clotting disorder or thrombophilia
  5. Significant pelvic or lower limb trauma
  6. Malignancy
  7. Pregnancy or recently post-partum

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): NCT03937947


Contacts
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Contact: Jonathan K Rhodes, PhD, MB ChB 0131 537 1666 jrhodes1@staffmail.ed.ac.uk
Contact: Rosaleen Baruah, MB ChB 0131 537 1666 rosaleen.baruah@nhs.net

Locations
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United Kingdom
Intensive Care Unit, Western General Hospital Recruiting
Edinburgh, Midlothian, United Kingdom, EH42XU
Contact: Jonathan KJ Rhodes, PhD MB ChB    0131 537 1666    jrhodes1@staffmail.ed.ac.uk   
Contact: Rosaleen Baruah, MB ChB    0131 537 1666    rosaleen.baruah@nhs.net   
Sponsors and Collaborators
NHS Lothian
Edinburgh Clinical Trials Unit
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Responsible Party: Jonathan Rhodes, Consultant in Intensive Care and Anaesthesia, NHS Lothian
ClinicalTrials.gov Identifier: NCT03937947    
Other Study ID Numbers: AC18105
WKR0-2018-0020 ( Other Grant/Funding Number: British Journal of Anaesthesia )
WKR0-2018-0020 ( Other Grant/Funding Number: Neuro Anaesthesia and Critical Care Society )
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share data at present.

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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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Pneumonia, Ventilator-Associated
Lung Injury
Acute Lung Injury
Brain Injuries
Brain Injuries, Traumatic
Thrombosis
Venous Thrombosis
Wounds and Injuries
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thoracic Injuries
Cross Infection
Infection