The Relevent trial: Rate of Lower Limb Deep Venous Thrombosis in patients with Traumatic Brain Injury (TBI): a pilot observational study

The Relevent trial: Rate of Lower Limb Deep Venous Thrombosis in patients with Traumatic Brain Injury (TBI) admitted to intensive care: a pilot observational study

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12608000330347

Enrollment

100

Registered

2008-07-15

Start date

2008-07-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Patients who are admitted to the intensive care unit with traumatic brain injuries (TBI) are at a significant risk of developing blood clots in their legs because (1) they are immobile, (2) their blood clots more quickly (part of the stress response to TBI) and (3) they tend not to be prescribed anti-clotting medication as they are at risk of further bleeding into their brain. About 30% of blood clots in the lower leg extend into the thigh and if untreated half of these will travel to the lung. Of those clots that travel to the lung 25% cause death. There is no current Australian or international data concerning the rate of blood clots in the legs in TBI. We plan to assess all patients with TBI on admission to the intensive care unit for blood clots by performing an ultrasound of their legs and repeating this twice weekly until discharge. We also plan to determine each participant’s propensity to develop clots: this shall be done by performing a blood test (1 teaspoon) called a thromboelastogram and these tests shall be done whenever a patient has an ultrasound. The results of the study will provide currently unknown data regarding the rate of lower limb blood clots in this at risk population. This in turn will help in the design of a future clinical trial comparing different clot prevention strategies in these patients.

Interventions

Patients shall have ultrsonography and a thromboelastogram (blood test) performed on admission and thence every four days until death or discharge from the intensive care unit (ICU). The ultrasonography examination will take approximately 20 minutes. Patients will remain in the study whilst in the ICU.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

(1) Patients with TBI who are admitted to ICU (Glasgow Coma Scale <15), (2) age > 18 years, (3) no longer than 48 hours since primary traumatic injury, (4) expected to remain at least 96 hours in ICU.

Exclusion criteria

(1) Pregnancy or lactation, (2) inability to perform lower limb ultrasounds, (3) lack of consent, (4) enrolment in another trial.

Outcome results