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

Completed · Phase 1 · Has a placebo group

Conditions studied: Venous Thromboembolism, Traumatic Brain Injury

In brief

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.

Key facts

Study ID

NCT01014403

Run by

University of Texas Southwestern Medical Center

People needed

62

Starts

2009-11-01

Expected to finish

2011-05-01

Last updated by the study team

2021-01-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female patients admitted to the ETMC SICU with TBI who speak English or Spanish.

You may not qualify if…

• Epidural or subdural hematoma > 8mm.
• Intraparenchymal contusion >2 cm
• Multiple contusions w/in one lobe
• Subarachnoid hemorrhage in basilar or supracellar cistern and positive CTA
• Increased TBI on 24 hr post-injury CT
• Spinal canal hematoma
• Nonoperative mgmt of American Association for the Surgery of Trauma (AAST) Grade IV or higher organ injury
• Gastrointestinal hemorrhage
• Ongoing bleeding from a pelvic fracture
• Anticipated open reduction of long bone or pelvic fracture within study period.
• Intracranial pressure (ICP) >20 mmHg
• Coagulopathy consisting of International Normalized Ratio (INR)>1.5 or platelet count <50,000
• Expect brain death/discharge in 48 hrs
• Pre-existing dialysis dependence
• Documented DVT at time of admission
• Prisoners
• Pregnancy
• Age <18 years
• Terminally ill patients
• Anticoagulant use at time of injury
• Inability to gain consent from patient or legal next-of-kin in instance of TBI, intoxication, or psychiatric diagnoses
• Documented history of heparin allergy
• Initial head CT >6 hours post-injury

Where it is running

• UT-Southwestern Medical Center — Dallas, Texas, United States
• East Texas Medical Center — Tyler, Texas, United States

Full record on ClinicalTrials.gov

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