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

NCT01014403 | Completed Phase 1 Results

• 1 other identifier: 082009-026
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Venous Thromboembolism; Traumatic Brain Injury

Keywords

venous thromboembolism; enoxaparin; traumatic brain injury; Venous thromboembolism prophylaxis traumatic brain injury

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Worsening TBI Hemorrhage

  Worsening of TBI hemorrhage pattern on any scheduled or PRN CT scans after the initiation of treatment

  24 hours after the start of treatment/48 hours after the time of injury

Secondary Outcomes (2)

• Extracranial Hemorrhagic Complications

  prior to discharge

• Count of Participants With Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)

  prior to discharge

Study Arms (2)

enoxaparin 30 mg SQ q12 hours

EXPERIMENTAL

Enoxaparin started at 24 hours post-injury and continued until 96 hours post-injury.

Drug: enoxaparin

placebo

PLACEBO COMPARATOR

vehicle administered sq q 12 hours

Drug: placebo

Interventions

enoxaparin DRUG

Enoxaparin 30 mg sq q 12 hours

enoxaparin 30 mg SQ q12 hours

placebo DRUG

vehicle

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (2)

UT-Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

East Texas Medical Center

Tyler, Texas, 75701, United States

Location

MeSH Terms

Conditions

Venous Thromboembolism; Brain Injuries, Traumatic

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Dr. Herb Phelan
• Organization: UT Southwestern Medical Center

herb.phelan@utsouthwestern.edu

214-648-6841

Study Officials

• Herb A Phelan, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2009
• First Posted: November 17, 2009
• Study Start: November 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: January 13, 2021
• Results First Posted: January 13, 2021

Record last verified: 2020-12

Locations

US (2)