TARDIS Study
Research type
Research Study
Full title
Traumatic Brain Injury Associated Radiological DVT Incidence and Significance (TARDIS) Study
IRAS ID
254346
Contact name
Jonathan Rhodes
Contact email
Sponsor organisation
NHS Lothian
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 10 months, 29 days
Research summary
Patients with traumatic injury to the brain are believed to be at an increased risk of blood clots forming in the legs and pelvis. The risks of blood clot formation can be reduced by administration of blood thinning drugs to inhibit the clot forming process. However this thinning of the blood could lead to bleeding in and around the brain, causing further brain injury. The use of blood thinning drugs therefore tends to be delayed for many days compared to normal care. This increases the risk that blood clots can form.
The consequences of these clots can be serious. They can move into the lungs, causing an immediate and dramatic threat to life. More subtly, they may also be associated with greater requirements for life supporting care, and poorer outcomes. Furthermore, this patient group is also at increased risk of respiratory infection, and we propose that this could be related to the presence of clots.
Unfortunately, the existing research literature is incomplete. The best time to start blood thinning treatment and the effect of blood clot formation on patient outcome is unknown.
This study aims to identify the incidence of blood clots in patients after traumatic brain injury and any risks associated with this. Non-invasive ultrasound scans of both legs will be performed on alternate days up to 10 days after brain injury in the intensive care unit. We will collect information on incidence of blood clot and any injury to the lungs including; infection and number of days on a breathing machine, and also measure the patient’s recovery, using a questionnaire 6 months from injury. Data collected will be compared between those patients who develop blood clots in the legs and those that do not so that we can find out if developing a clot may affect patient outcome.
REC name
Scotland A REC
REC reference
19/SS/0001
Date of REC Opinion
24 Jan 2019
REC opinion
Favourable Opinion