Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01014403 |
| Other study ID # |
082009-026 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
November 2009 |
| Est. completion date |
May 2011 |
Study information
| Verified date |
December 2020 |
| Source |
University of Texas Southwestern Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
We propose to conduct a placebo-controlled non-inferiority pilot study to evaluate the rate
of worsening of intracranial injury patterns after initiation of enoxaparin in TBI patients.
Patient enrollment will occur at ETMC, blinded re-reading of CTs will occur at PMH, and
administrative/analytical support will occur at UTSW. The study design will be a
double-blind, randomized controlled trial in the ETMC Surgical Intensive Care Unit (SICU)
consisting of 40 patients per arm. The decision for 80 patients was resource-based, as this
is a pilot study. Further, we anticipate the need to contact 3 patients in order to obtain 1
successful recruitment.
Each arm will consist of low-risk TBI patients (defined as patients with a subdural or
epidural hematoma < 8mm, intraparenchymal contusion < 2 cm, and/or single contusion per lobe)
who have had a CT scan of the head without contrast at 24 hours post-injury which documents a
stable injury pattern. The severity of neurologic deficit will have no bearing on their
suitability for participation, and will not be considered in inclusion/exclusion criteria.
After documentation of a stable intracranial injury pattern at this time interval, patients
will be randomized to receive either enoxaparin 30 mg SQ every 12 hours or placebo with each
regimen being initiated at 24 hours post-injury. A follow-up CT scan of the brain without
contrast will be obtained on all patients 48 hours post-injury (and 24 hours after the
initiation of enoxaparin/placebo). An additional CT scan of the brain without contrast will
be obtained on any patient who experiences an abrupt change in neurologic exam at any time
between the initiation of enoxaparin/placebo and the end of the study's interventional period
at 96 hours post-injury (this time frame was chosen as it is the earliest time point at which
there is universal agreement among both of our group's practitioners that enoxaparin use is
safe from the risks of TBI expansion). Any patient with a worsened CT scan will have their
investigational treatment discontinued at that time. At 96 hours post-injury, the
interventional portion of the study will end, data collection for the primary endpoint will
cease, and all patients will be placed on enoxaparin for the remainder of their hospital stay
as per local standards of care. Patient participation in the study will last from the time of
injury to 96 hours post-injury for the interventional part of the study, and from 96 hours
post-injury until discharge from ETMC for the observational portion. While this latter time
frame is obviously extremely variable, it averages approximately one to two weeks. During
both the interventional and observational time periods, patients will have Duplex
ultrasonography of the lower extremities performed for an edematous extremity, CT-angiography
of the chest for unexplained hypoxia or tachycardia, and ventilation-perfusion scanning for
suspicion of PE in the presence of a contraindication to IV contrast.
