Current Studies in The Trauma Program
Richard J. Mullins
RURAL TRAUMA SYSTEM STUDY GROUP
BACKGROUND
Acute care of a seriously injured patient is most effective if care is immediate and surgeons
deliver treatments in an optimal sequence. Trauma systems are public health care policies
intended to assure that patients receive effective acute care. Trauma system administrators
promulgate guidelines, which are hypothesized to assure timely and efficient patient care.
While trauma systems in urban communities have consistently improved outcome, clear evidence
is lacking that statewide trauma systems have improved survival of injured patients in
rural communities. Over the past ten years research published by our study group,
the Rural Trauma Study Group, has indicated that Oregon’s trauma system has improved the
outcome of seriously injured patients, particularly those with brain injury treated in the level
1 trauma centers. Our research has indicated that inter-hospital transfer decisions regarding
brain injured patients treated in rural hospitals are a key area for further improvements in
the effectiveness of Oregon’s statewide trauma system.
METHODS AND RESOURCES
Our outcomes research studies have been principally observational studies. The methods we use
are similar to those reported in epidemiology texts. Plausible outcomes research depends upon
accurate and comprehensive data on the population of interest. We have electronic copies of
analyzable databases. These databases are extensive archives of information on hospitalized
injured patients in Oregon and Washington State. Outcomes research is dependent upon appropriate
use of robust statistical analyses. We perform our statistical analyses principally using SPSS.
To evaluate the influence of trauma systems we have relied upon risk adjusted models, which predict patient’s survival. We have carefully developed methodology, which enables us to achieve a consistent insight into the quality of medical care. With our recent publications we have extended beyond outcomes studies, and have also examined the utility of evaluating processes of care and injury prevention. When students or residents participate in the outcomes studies performed by the Rural Trauma System Study Group, we encourage them to focus on testing a hypothesis using data and methods, which are already available. Our preference is for the new investigators to develop skill at manuscript preparation and publication.
PLANNED RESEARCH PROJECTS FOR THE FUTURE
Our current research plan for the next three years has three components. First we will obtain
long-term follow-up on geriatric patients following injury-using SF-36, a questionnaire that
provides a measure of quality of life. Second we will expand our brain injury database for the
purpose of comparing the processes of care delivered to brain injured patients directly
transported to level 1 or 2 trauma centers to processes of care delivered to similar patient who
first present to rural hospitals. A third goal will be to complete an analyses of recently
acquired data to determine if a decision rule can be developed which can accurately classify
patients in rural hospitals who would benefit from transfer to a higher level trauma center.
Funded by the Centers for Disease Control and Prevention R49/CCR 006283-07 and the Trauma
Education and Research Fund.
Ladder Fall Study
Falls from ladders have been recognized as a common cause of significant morbidity and even
mortality among patients admitted to the OHSU trauma service. The majority of patients fell from
ladders while working at home. Many were over the age of 60. The current ladder fall study has
two goals. First a detailed questionnaire has been developed to determine the exact mechanism of
injury, which is the cause of the patient falling from the ladder. Second the characteristics of
the patients preexisting health status, which might contribute to the ladder fall, are determined.
The purpose of the questionnaire is to better define area where prevention training might be
effective.
Hyponatremia Protocol Study
In this study we are investigating what causes hyponatremia in the trauma patient, and how
it is best treated. Patients with brain injury are at increased risk for the development of
cerebral edema if they have hyponatremia. The lower the serum sodium, the lower the osmolality
and the greater the cell swelling, which may cause increases in intercranial pressure.
The specific causes of hyponatremia can be divided into two physiologic mechanisms,
excessive retention of water and excessive loss of sodium in urine. The first is commonly
attributed to the syndrome of inappropriate antidiuretic hormone. The second may relate to the
influence of naturetic peptide released from the injured brain. Therapeutic implications of these
two diagnoses are clear: SIADH patients are treated with water restriction, while salt loss
required transfusion with hypertonic sodium. Further study is being conducted to determine the
utility of urine sodium concentrations in evaluating these patients.
John C. Mayberry, MD
Dr. Mayberry is leading the effort at OHSU to define the effective surgical and non-surgical strategies for rib and sternal fractures. He is the lead investigator on several past and present clinical trials.
For more information see: Rib Fracture Clinic
“Prospective Trial of Operative Management of Rib Fracture Non-Union”
IRB# 4073
Status: Enrolling
Rib fractures are a painful and disabling injury commonly found among trauma patients.
Patients with rib fracture non-union (failure to heal 3 months from injury) present a
unique challenge because of persistent pain associated with fracture movement.
New techniques in rib fracture non-union repair with surgery have thus far been promising
but a more rigorous trial of efficacy is warranted. Our goal is to track the outcomes of
surgical rib fracture repair while following the progress of patients with chronic rib
fracture non-union as they wait for surgical treatment. Once enrolled, patients will be
interviewed every two months, for up to six months, to evaluate their functional and work
status, pain, and disability. If patients undergo operative treatment of their rib
fracture non-union they will be interviewed for an additional 6 months at 60 day intervals
to evaluate functional status, pain, and disability. We are currently enrolling with a
goal of 50 participants.
“Prediction of Prolonged Pain and Disability Following Rib Fractures”
IRB#: 2611
Status: Closed to enrollment, results pending
Review date: September 3, 2009
Surprisingly, the outcomes of patients with rib fractures are not well known and
this lack of knowledge is an obstacle to developing treatments that might be
expected to improve the outcome of rib fracture patients. We are assembling a
database that will be used to report the demographics of rib fracture patients
and to estimate the prevalence of pain and disability due to rib fractures in the
United States as a whole. Patients were recruited within 14 days of injury, with
information collected about pain and disability related to the rib fracture.
Participants were surveyed again at 60 days, 120 days, and 180 days post-injury to
evaluate pain and disability associated with the rib injury. Recruitment and data
collection are complete, and we are currently reviewing and analyzing the data.
We anticipate the results will be available in 2010.
Causes and Circumstances of Horse Related Injuries and the Impact on Quality of Life
OHSU IRB #4084
Status: Closed to enrollment, results pending
Horse-related activity can be risky. Horses are the leading cause of
animal-related fatalities in Oregon and Oregon's annual death rate from
animals is 45% higher than the national rate. By interviewing injured
equestrians, we may be able to determine patterns of decision-making and
behavior from their collective experience and develop useful safety
recommendations. We also aim to determine the impact that the injury has
had on overall quality of life. The long-term goal of our research is to
develop safety and prevention recommendations and a horse-related injury
prevention program to reduce the number of horse related injuries. The investigators
are evaluating the results from the surveys, and intend to submit the results for
scientific publication in 2010.
Bicycle Commuter Injury Prospective Observational Study
OHSU IRB #3590
Status: Closed to enrollment, results pending
The objective of our research is to determine the risk, incidence and circumstances
of traumatic injuries associated with bike commuting in Portland, Ore., as well as
the concurrent impact of injury on an individual’s health and employment. Bicycling
magazine has named Portland the “Best Cycling City in the USA” since 1995, and the
number of bicycle commuters has increased over 250% in the last 14 years. However,
bicycle accidents are associated with significant injury, healthcare cost, and time
off work. Bicycle commuters were recruited via the web and community advertising
to participate in a prospective, one year survey. Subjects completed an initial
online survey to determine demographics, safety practices, experience level and past
event history. Subsequently, participants were invited to complete 12 monthly
surveys describing their commutes from September 2007 through August 2008. An
abstract has been accepted to Eastern Association for the Surgery of Trauma (EAST)
for the January 2010 meeting in Phoenix, Ariz. We anticipate the release of study
results for this study in the spring of 2010.
Damage Control for Duodenal and Combined Duodenal-Pancreatic Injuries
OHSU IRB #5128
Status: Active, limited to chart review for past OHSU patients meeting study criteria
The management of significant duodenal injuries and combined duodenal-pancreatic
injuries continues to be challenging and controversial, and several techniques
have been advocated over the years. One technique surgeons employ is the damage
control/planned reoperation strategy. At our trauma center, the advent of damage
control and other planned re-operation strategies has resulted in an evolution in
our management of duodenal lacerations and combined duodenal-pancreatic injuries.
In this retrospective review, we intend to quantify our change in practice and to
report its outcome compared to previous practice.
Using the OHSU Trauma Laparotomy Outcomes Database, we will identify all patients
receiving trauma laparotomy for a duodenal or duodenal-pancreatic injury for a
period of 20 years, from 1989-2009. A number of data points will be retrieved
from patients’ medical records, including but not limited to grade of duodenal
injury, mechanism of injury, Injury Severity Score (ISS), and others. A
scientific abstract has been submitted to a major trauma organization for
consideration of a 2010 presentation.
Robert K. Goldman, MD
Basic Research
I am principally interested in translating knowledge gained from the lab into the clinical
problem of shock. We are investigating the physiologic consequences of the intriguing
biochemistry of nitric oxide. The physiology and biochemistry of nitrosothiols–long acting
adducts of NO–are of special interest. Other investigations address organ dysfunction and
organ protection during inflammatory stress.
Clinical Research
My main focus is evaluating outcomes concerning fundamental critical care issues germane to
trauma patients. These problems, for example, have included liberation from mechanical
ventilation, pulmonary embolism, and complications of liver injury. One of my hobbies is
digital photography and applying computer technology toward conducting clinical research
Martin A. Schreiber, MD
The Relationship Between Hypercoagulability and Organ Failure
Despite major advances in critical care, the mortality in patients with Adult Respiratory
Distress Syndrome and Multiple Organ Failure remains high. This study seeks to test the
hypothesis that these deadly syndromes are associated with a hypercoagulable state. If this
association can be established, newer therapies designed to combat the hypercoagulable state will
be tested as prophylaxis for organ failure. This project is supported by the National Institutes
of Health by a grant through the General Clinical Research Center at OHSU.
Coagulation Parameters after Splenectomy in Adult Trauma Patients
The prolonged risk of a hypercoagulable state following trauma
splenectomy beyond acute thrombocytosis is not recognized by the trauma
community or considered in the decision to preserve the spleen. An
evaluation of a pure trauma patient population including the appropriate
control group could significantly add to the trauma literature and
potentially affect a change in the management of patients with splenic
injuries. This study will also characterize the thrombophilia that
follows trauma splenectomy. By doing this, it will clarify the optimal
therapeutic prophylaxis. The proposed study will be unique in that it
will be the first study in the literature to compare a trauma splenectomy
population to the appropriate control group of trauma patients. The
incidence of thromboembolic complications in untreated trauma patients
is reported to be 58%. This is amongst the highest incidence for any
population. The duration of time that this risk persists is unknown and
has never been studied. Therefore, hypercoagulability following
splenectomy in trauma patients cannot be distinguished from
hypercoagulability from trauma without an equivalent control group.
This study will control for trauma by selecting a concurrent and
well-matched group of injured patients with splenic injuries who
underwent splenic salvage. This project is supported by the National
Institutes of Health by a grant through the General Clinical Research
Center at OHSU.
Can TEG be used in place of anti-Factor Xa to assess enoxaparin
levels in patients with comorbiditites?
The purpose of this study is to determine whether the TEG® will show
alterations in coagulation produced by enoxaparin (LMWH) and to compare
the effects of LMWH in a diverse patient population to include the
morbid obese, patients with a creatinine clearance of <30ml/minute and
the elderly, or injured patients.
Although enoxaparin (Lovenox®) is dosed uniformly there is a variable
effect based on comorbid status of age, morbid obesity and renal
function and this effect can be demonstrated through the use of t
hrombelastogram testing. This project is supported by the National
Institutes of Health by a grant through the General Clinical Research
Center at OHSU.
The Effect of Fluid Resuscitation on Outcome After Trauma
In addition to stopping hemorrhage, fluid resuscitation is a critical aspect of the
management of bleeding trauma patients. The optimal endpoints of resuscitation and the best
resuscitation fluid have not been determined. This study is designed to determine the effect
of 4 commonly used resuscitation fluids and 3 different resuscitation endpoints on coagulation,
bleeding, survival and inflammation in a massive liver injury. This project has been submitted
to the Department of the Navy for funding.
Resource Utilization in Head Injured Patients on Blood Thinners
This study is to determine if in fact there are statistically
significant differences between patients receiving anti-coagulation
therapy and those not receiving anti-coagulation therapy in regards
to etiology, pathophysiology, management and outcome. This data will
be further utilized to determine measures that may be taken to improve
outcomes in this high-risk population. This study is currently not
funded.
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