Delayed Versus Early Enoxaparin Prophylaxis After Traumatic Brain Injury (TBI)
Condition: Venous Thromboembolism; Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Thromboembolism; Venous Thromboembolism; Wounds and Injuries
Intervention: enoxaparin; placebo
Intervention description: Enoxaparin 30 mg sq q 12 hours; vehicle
Intervention MeSH terms: Enoxaparin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: venous thromboembolism; enoxaparin; traumatic brain injury; Venous thromboembolism prophylaxis traumatic brain injury

Summary:

      Brain injured patients are at high risk for forming blood clots in the legs and lungs. For
      non-brain injured trauma patients, we decrease the chances of these blood clots forming by
      placing the patients on a low dose of the blood thinner enoxaparin. Starting patients with a
      brain injury on the blood thinner is problematic, however, as this can theoretically cause
      the brain injury to worsen. Trauma surgeons wait a variable period of time before starting
      this blood thinner because waiting too long can result in the formation of these blood clots
      in the legs and lungs. Previous research has shown that some brain injuries which are of
      lower severity can have enoxaparin started at 24 hours after injury if the brain injury is
      stable on a repeated computed tomography (CT) scan of the head. This is a pilot study
      designed to look at the rates of worsening of brain injury if the low dose blood thinner is
      started at 24 versus 96 hours post-injury.
    

Eligibility criteria:

        Inclusion Criteria:

        1. Male and female patients admitted to the ETMC SICU with TBI who speak English or
        Spanish.

        Exclusion Criteria:

          1. Epidural or subdural hematoma > 8mm.

          2. Intraparenchymal contusion >2 cm

          3. Multiple contusions w/in one lobe

          4. Subarachnoid hemorrhage in basilar or supracellar cistern and positive CTA

          5. Increased TBI on 24 hr post-injury CT

          6. Spinal canal hematoma

          7. Nonoperative mgmt of American Association for the Surgery of Trauma (AAST) Grade IV or
             higher organ injury

          8. Gastrointestinal hemorrhage

          9. Ongoing bleeding from a pelvic fracture

         10. Anticipated open reduction of long bone or pelvic fracture within study period.

         11. Intracranial pressure (ICP) >20 mmHg

         12. Coagulopathy consisting of International Normalized Ratio (INR)>1.5 or platelet count
             <50,000

         13. Expect brain death/discharge in 48 hrs

         14. Pre-existing dialysis dependence

         15. Documented DVT at time of admission

         16. Prisoners

         17. Pregnancy

         18. Age <18 years

         19. Terminally ill patients

         20. Anticoagulant use at time of injury

         21. Inability to gain consent from patient or legal next-of-kin in instance of TBI,
             intoxication, or psychiatric diagnoses

         22. Documented history of heparin allergy

         23. Initial head CT >6 hours post-injury