None listed
Conditions
Brief summary
Venous thromboembolism (VTE) is a significant health problem especially in hospitalized patients, with a high associated morbidity and mortality. For most patients, the standard of care is to use prophylactic anticoagulation (heparin) and intermittent pneumatic compression to both lower limbs. There is a group of patients who are at very high risk of VTE but these VTE prophylactic measures cannot be used or considered adequate, either for physical reasons (lower limb fractures / open wounds ) or risk of bleeding from anticoagulants (such as severe brain injury). In these patients, the options are to use no intervention or to insert an Inferior Vena Cava filter (IVCF). Although IVCFs are widely used as a mechanical VTE prophylaxis in patients who have contraindications to conventional VTE prophylactic measures, their effectiveness in this regard has not been established. This phase II / III randomized controlled trial aims to assess the clinical effectiveness, benefits and harms, and also the cost- effectiveness of the early use of IVCFs (<72 hrs of admission after severe injury) for trauma patients who have contraindications to conventional VTE prophylactic measures (pharmacological thromboprophylaxis). This trial has the capacity to influence the management of trauma patients worldwide, and to establish the place of IVCFs in modern medical practice.
Interventions
The filter should be inserted within 72 hours of admission to the study center
Sponsors
Medical Research Foundation, Royal Perth Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients will be eligible for the trial (1) if they are considered to have contraindications to pharmacologic thromboprophylaxis within 72 hours of hospital admission by their attending trauma or neurosurgeons AND (2) Injury Severity Score >15.
Exclusion criteria
1. Severe head or systemic injury where death within 48 to 72 hours is expected. 2. Attending clinicians judge that patients are at low-risk of bleeding and can receive pharmacologic thromboprophylaxis within 3 days after major trauma. 3. Patients who have CT evidence of pulmonary embolism on admission to the hospital after trauma. 4. Patients who have been treated with full systemic anticoagulation by warfarin, UFH or LMWH for a pre-existing medical disease (e.g. patients with chronic atrial fibrillation requiring systemic anticoagulation) until admission due to trauma. 5. Pregnant patients. Specific contraindications to heparin or other form of pharmacologic thromboprophylaxis are listed below. 1. Intracerebral haematoma or contusions 2. Active bleeding on admission requiring more than 6 units of blood transfusion within the first 24 hours of admission after the injury 3. Spinal cord injury resulting in neurological deficits or spinal cord haematoma is demonstrated in the MRI scan of the spine 4. Complex pelvic fractures resulting in significant retroperitoneal haematoma 5. Complex visceral organ injuries (e.g. splenic and liver lacerations) resulting in high risk of intraperitoneal bleeding 6. Others, please specify
Outcome results
None listed