TBI (Traumatic Brain Injury), VTE (Venous Thromboembolism)
Conditions
Brief summary
This study compares the efficacy and complication rates of early (24 hours) versus late (72 hours) VTE prophylaxis administration to TBI patients. Patients in both treatment groups will be monitored for development of VTE as well as complications from bleeding after commencement of VTE prophylaxis.
Detailed description
This a randomized prospective study that compares the efficacy and complication rates of early (24 hours) versus late (72 hours) VTE prophylaxis administration to TBI patients. Patients who are identified as having an intracranial injury will be randomized to early versus late VTE prophylaxis using a 1:1 random numbers allocation. Patients in both treatment groups will be monitored for development of VTE, primarily with scheduled duplex ultrasound studies of the lower extremities. Any clinical suspicion of VTE will also be investigated with duplex ultrasound and/or CT angiogram of the chest. Patients will be monitored for development of complications from bleeding post commencement of VTE prophylaxis. Intracranial bleeding complications will be monitored by physical examination and CT scanning of the head when indicated. Patients who undergo craniotomy or craniectomy will have VTE prophylaxis started 72 hours post-surgery and will undergo CT scan of the head (to assure bleeding stabilization) prior to administration of VTE prophylaxis.
Interventions
DRUGEnoxaparin Sodium 150 MG/ML Prefilled Syringe
The same drugs and dosages will be used in both groups, with only the timing being different
DRUGHeparin
The same drugs and dosages will be used in both groups, with only the timing being different
Sponsors
Loyola University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Traumatic brain injury * Intracranial hemorrhage on CT scan
Exclusion criteria
* Under the age of 18 * Pregnant * Die within 24 hours of admission * Hospital stay less than 5 days * Contraindications to enoxaparin or heparin * Coagulopathy at 24 hours post-injury defined as INR\>1.6 aPTT\>2x normal, or platelet counts\<50k * Known history of VTE
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VTE | Outcomes will be assessed until hospital discharge. Data will be presented at study completion with the expectation of approximately 2 years. | Rate of venous thromboembolism (DVT or PE) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding complications | Outcomes will be assessed until hospital discharge. Data will be presented at study completion with the expectation of approximately 2 years. | Rate of expanding intracranial hemorrhage |
Countries
United States
Outcome results
None listed