Delayed Versus Early Enoxaparin Prophylaxis After Traumatic Brain Injury (TBI)

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Treatments: Enoxaparin

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