Page 56 - NNS 2014 Program & Abstract Book

SEPs were graded as bilaterally absent, unilateral absence, bilateral
delay > 23ms, unilateral delay with normal, and bilateral normal la-
tency. Functional outcome was prospectively collected at 12-month
follow-up, and included neurologic status and mortality as assessed by
Glasgow Outcome Scale (GOS). 134 patients were available for
analysis. Median GCS was 6 (IQR 2), while median radiographic
injury was a Marshall score 3 (IQR 2). Mean age was 38 – 16. Uni-
variable analysis of SEP demonstrated significant ordinal prediction of
outcome according to GOS; for every increase in SEP grade, there
was an increased chance of favorable outcome [OR = 1.59 (1.3–1.9),
p < 0.001]. SEP demonstrating bilateral delayed latencies, unilateral
delayed latencies, or normal SEP responses significantly differentiated
favorable vs. unfavorable outcome (OR 5.78, 95%CI 2.43-13.7,
p < 0.001). These findings remained significant regardless of age, ad-
mission GCS, or radiographic injury severity (p > 0.59 respectively).
Diagnostic neurophysiological testing in the acute phase of severe
TBI has shown to be a significant predictor of long-term outcome.
Key words
clinical, imaging, neurophysiology
A1-21
LESSONS IN CRITICAL CARE RESEARCH FROM A
GLOBAL PHASE 3 TRIAL OF PROGESTERONE IN PA-
TIENTS WITH SEVERE TBI
Nelson, N.R.
Besins Healthcare/BHR Pharma, LLC, Herndon, VA
BHR-100 progesterone i.v. infusion was studied as a potential neuro-
protectant for severe TBI. The SyNAPSe Phase 3 placebo-controlled
randomized clinical trial was conducted in 21 countries on patients with
severe TBI (Glasgow Coma Scale 3–8). The trial has been completed,
overcoming numerous challenges in clinical trial research in the critical
care environment.
Sites were selected based on patient potential and standardized care
according to Brain Trauma Foundation or equivalent treatment
guidelines. Centralized review of CT scans, Glasgow Outcome Scores
(GOS), and protocol compliance was conducted. Subjects required
proxy consent to enter the study and were randomized in a 1:1 ratio to
BHR-100 or placebo. The study drug infusion must have been initi-
ated within 8 hours of brain injury, and administered for 120 con-
tinuous hours. All study procedures were required to be completed in
the context of not interfering with the patients’ medical care. Patient
follow up continued to 6-months post-injury, or death if earlier.
Nearly 1200 subjects were randomized in 36 months. Most sites
were able to overcome challenges of the 8-hr treatment window and
enroll at least one patient. Successful sites had organized study teams
and adequate resources, with at least one study ‘champion’. Training
or experience in emergency consent was essential, as well as thorough
knowledge of all study assessments to ensure protocol compliance and
data quality. Rigorous follow up and site and patient support was
needed to collect the primary endpoint (GOS). The sponsor oversaw
three CROs, multiple central services, and over 150 centers to conduct
the trial.
Although bench-top researchers aim for eventual confirmation in a
Phase 3 trial, conducting such a trial involves numerous challenges
from an organizational as well as a participating site perspective. The
SyNAPSe trial was completed and provides useful lessons for re-
searchers planning future TBI or other critical care trials.
Key words
critical care research, SyNAPSe trial
A1-22
TREATMENT OF REFRACTORY INTRACRANIAL
HYPERTENSION IN PATIENTS WITH TRAUMATIC
INTRACRANIAL USING DECOMPRESSIVE CRANIECTOMY
Kuzibaev, J.M., Makhamov, K.E.
Republican Research Center of Emergency Medicine, Tashkent,
Uzbekistan
We compared the effect of early decompressive craniectomy (< 24 h)
with that of non-operative treatment on the outcome of patients with
refractory intracranial hypertension following severe traumatic brain
injury.
A retrospective review was conducted of 24 consecutive patients
who presented between 2010 and 2013 with refractory intracranial
hypertension following isolated severe head injury with intracra-
nial hematomas. Early decompressive craniectomy after hematoma
removal (mean time from injury: 6.2 – 3.2 h) was carried out in 12
patients (mean age: 35.3 – 5.4 years), whereas 12 patients (mean
age: 38.4 – 3.1 years) were underwent only hematoma removal
without decompressive craniectomy. In all patients treatment in-
cluded sedation, paralysis, and IV mannitol under ICP monitoring.
In the early decompressive craniectomy group 3 patients had EVD
insertion and 5 had hypothermia. In the non-decompressive treat-
ment group 4 patients had EVD insertion and 3 had hypothermia.
The Glasgow Outcome Scale at follow-up was used as outcome
measure.
All patients in the early decompressive craniectomy group sur-
vived; 3 patients scored 5, 5 patients scored 3 and 4 patients scored 4
on the GOS. In the non- decompressive treatment group 3 patients
died, 2 patients scored 5, 3 patients scored 4 and 4 patient scored 2 on
the GOS.
Early decompressive craniectomy, employed prior to the onset of
irreversible ischemic changes, may be an effective method of treating
the secondary deterioration from refractory intracranial hypertension
following severe head injury with intracranial hematomas.
Key words
craniectomy, hematoma, intracranial hypertension
A2-01
MONITORING MILD TRAUMATIC BRAIN INJURY WITH
POLARIZATION-SENSITIVE OPTICAL COHERENCE
TOMOGRAPHY
Szu, J.I., Rodriguez, C.L., Park, B.H., Binder, D.K.
University of California, Riverside, Riverside, USA
Mild traumatic brain injury (mTBI) may lead to disorientation and
impaired consciousness and other neurological and cognitive se-
quelae. However, imaging diagnosis of mTBI is challenging. Since
mTBI is diffuse, it is common for typical neuroimaging (CT and MRI
scans) to show no evidence of injury. While it is clear that mTBI can
lead to white matter damage, standard imaging techniques are poor
at detecting mild injury. Therefore, in this study, we employed
polarization-sensitive optical coherence tomography (PS-OCT) to
detect continuous changes in tissue structure within the brain in a
mouse model of mTBI. PS-OCT is capable of quantifying tissue
birefringence, a phenomenon caused by highly organized tissue ar-
chitecture such as myelin, by imaging the sample with two orthogonal
polarization states. Using PS-OCT we observed a loss of birefringence
within 30 minutes of impact. Furthermore, we correlated this decrease
A-24