Phase 1 N=62 Randomized Quadruple-blind Treatment

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

Venous Thromboembolism · Traumatic Brain Injury

Bottom Line

View on ClinicalTrials.gov: NCT01014403 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2021

Primary outcome: Primary: Percentage of Participants With Worsening TBI Hemorrhage — 5.9; 3.6 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: enoxaparin (Drug); placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Texas Southwestern Medical Center
Primary completion: May 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Worsening TBI Hemorrhage	5.9; 3.6	—
SECONDARY Extracranial Hemorrhagic Complications	0; 0	—
SECONDARY Count of Participants With Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)	0; 1	—

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

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

Exclusion Criteria

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 6 hours post-injury

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01014403). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.