the PowerPoint - Oregon Health & Science University

Traumatic Injuries,
Bleeding & Shock
The Hypotensive Resuscitation versus
Standard Resuscitation Study (HypoResus)
What is this forum about?
To seek your opinion on the potential involvement of
yourself or a family member in a research study of IV
fluids in patients that suffer traumatic shock from
blood loss, that will be done under Exception From
Informed Consent (EFIC) guidelines.
Traumatic Injuries
• Trauma is the leading cause death for persons between the
ages of 1 and 44 years.
 It is also among the top 10 causes of death across all age groups.
• Severe bleeding, head and spinal cord injuries, or a
combination of these result in 80% of trauma deaths.
• More than half of trauma deaths occur within the first 12
hours after the injury.
• The most preventable death after trauma is exsanguinating
hemorrhage–severe bleeding that leads to shock.
 The presence of shock can be detected by a low blood pressure, fast
heart beat, confusion, pale skin, feeling cold
Deaths from Trauma
• Immediate—50% (at scene)
 Massive brain or spinal injury, cardiovascular event
• Early—30% (within first 24-48 hours)
 Severe brain injury, shock due to blood loss from torso trauma
• Late—20% (days to weeks)
 Multiple organ failure and overwhelming infection
 Influenced by inadequate early resuscitation or care
Field Management of Severe Blood Loss
• There are two major types of bleeding:
internal and external.
 There are currently no direct methods for controlling
bleeding resulting from internal injuries in the field.
 External bleeding is managed with pressure dressings,
tourniquets and other methods.
Treatment of Severe Blood Loss
• Traditional treatment for shock related to
severe blood loss is aggressive intravenous
(IV) fluid administration.
 The purpose is to attempt to restore circulating
blood volume and an adequate blood pressure.
 Fluids used in the field are typically either
normal saline (salt water solution) or Lactated
Ringer’s solution (balanced solution); also referred to
as “crystalloids.”
 This treatment method is currently endorsed by the
American College of Surgeons Committee on Trauma.
 Current guideline is to give trauma patients with shock
two or more liters of fluid.
Current Science & Studies
• Over the last 20 years, the practice of giving a high volume of
fluids for shock has come under some question.
 Clinical and basic science literature does not support this practice.
• There is growing evidence that early aggressive fluid
resuscitation with crystalloid-based fluids is associated with a
variety of complications.
• Both human and animal studies have shown the benefit of
delayed and minimal fluid resuscitation until severe bleeding has
been controlled.
Current Science & Studies continued…
• Human trials and observational studies have compared early
aggressive fluid administration to either delayed fluid
administration or minimal fluid administration.
 Some of this research has come from the military conflicts in Iraq and
• One study compared standard fluid administration to no fluids
until patients arrived in the operating room.
 Patients with delayed fluids had a higher survival rate and fewer
complications than those with standard fluids.
• Another similar study was conducted in the hospital setting.
 In this case, survival was the same in both groups.
Current Science & Studies continued…
• Two other studies compared fluid administration to no fluids in
the field.
 One found that the practice of fluids given in the field was associated
with a significant increase in the risk of death.
 Another compared trauma patients transported by EMS to those
transported by private vehicles in Los Angeles.
 Despite similar injuries, the outcome was much better in those
transported by private vehicles.
 The authors hypothesized that delays in transportation and IV fluids
in the field contribute to increased death.
Significance of the Research
• When internal bleeding occurs, blood clots form.
• It is the body’s attempt to stop the flow of blood.
 Similar to plugging a hole in a leaking hose.
• The theory is, giving these patients large amounts of fluids
dilutes the blood (minimizing the ability to clot) and “pops”
open the plugged holes.
Significance of the Research continued…
• Neither early aggressive administration of fluids in the field,
nor minimal or no fluid administration has proven to be
• Given that the current standard of care may be harmful to
trauma patients, a more comprehensive study is both
ethical and needed.
• It will be important to ultimately determine which strategy
for the treatment of severe bleeding is best for trauma
Goal of the HypoResus Study
• The primary aim of the trial will be to:
 To determine the feasibility and safety of minimal fluid administration
for the early treatment of patients with traumatic shock, compared to
standard fluid administration.
Big Bag
(1000 ml)
Small Bag
(250 ml)
Simply… we want to determine
what is the BEST treatment
strategy for trauma patients
suffering severe blood loss.
Study Fluids
Temporary photo until new kits available
Study Design
• Randomized controlled trial (a common method used in
clinical research).
• A sealed container will have either two small bags of normal
saline or one large bag of normal saline
• EMS personnel will not be able to see (“blinded”) the
contents of the containers until it is open.
• If it contains a large bag, the patient will receive high
amounts of fluid administration.
• If small bags, patient will receive a minimal amount of fluid.
Eligibility for Enrollment
(with no head injury)
“Opt-Out” Option
• Will be provided if desired.
• A “No Study” bracelet will be provided for those who
request one.
*To request a bracelet, call: 503-494-8083 or email
[email protected]
Notification & Consent
• Will be done as soon as possible after enrollment,
and will allow for an opportunity to withdraw from
further participation.
• Consent is obtained for the continued review of
your medical record, and only related to the
current admission.
Safety Monitoring
• The study will be monitored by:
 Data Safety Monitoring Board (DSMB)—an independent
 Institutional Review Board (IRB)
 Food & Drug Administration (FDA)
 National Institutes of Health (NIH)
What is Exception from Informed
Consent (EFIC)
• A federal regulation (21 CFR 50.24), allows certain
studies that meet the following criteria to use this
 Patients’ lives must be at risk.
 Available treatments are not satisfactory.
 Patients are unable to give consent.
 Potential risks are reasonable.
 Participation in the research could provide a direct benefit
(increased survival) to the patient.
 The research could not be carried out practically without this
EFIC Regulations
• Require community input and commentary for the proposed
 Public disclosure
 Community consultation
• Eligible patients for this study will require immediate
resuscitation, since without intervention, patients in shock face
imminent death.
• Traditional informed consent is impossible because:
 Patients with severe traumatic injury are unconscious, or in shock
and not capable of providing consent.
 Resuscitation has to be started immediately, and next of kin may not
be immediately available, or are likely to be too distraught to
understand an explanation of the study.
Do you have any concerns
regarding this proposed
research study?
For more information, visit our website at:
To be used if questions about
heart attacks come up in the
Who will be included in the study?
Patients Included
Patients Excluded
• Those with blunt or penetrating
injuries (abrasions, lacerations,
hematomas, etc.)
• Severe head injury
• Patients in shock (systolic blood
pressure less than or equal to 90)
• Known prisoners
• Age greater than or equal to 15 years
 Or, if age unknown, a weight of
greater than or equal to 50 kg
• Drowning or hanging
• Absence of severe head injury
 Or adequate level of consciousness
• Previous IV fluids given (>250 ml)
• Ongoing prehospital CPR
• Known/suspected pregnancy
• Significant burns
• Time from dispatch >4 hrs
• Blood pressure greater than 90
• Age less than 15 years
 Or weight <50 kg, if age unknown
Field Intervention Procedures
1000 mL bag
2000 ml
TKVO if SBP >110 mmHg,
restart if SBP <110 mmHg
Radial pulse or
SBP >70 mmHg
(keep vein open)
250 mL bag
No radial pulse or
SBP <70 mmHg
*Reassess SBP or radial pulse and repeat PRN
Give 250 ml*
Trauma Prevention
• Three basic strategies (Haddon)
• Education and persuasion
 e.g., safety messages, drivers education
• Legal regulation of behavior
 e.g., using drugs and/or alcohol
• Automatic protection
 e.g., safer vehicles
Metro EMS System
• Accessed by dialing 9-1-1
• Dual ALS system
• First Response (4-6 minutes)
 Fire ALS Engine, Truck or Rescue
 One or more paramedics
• Transporting Ambulance (within
8 minutes)
 One or two paramedics
• Aeromedical system (400 scene
Tri-County Level 1 Trauma Centers
Legacy Emanuel
Hospital & Health Center
Oregon Health
Sciences University
Clark County Level II Trauma Center
Peace Health Southwest
Medical Center
Hospital Trauma Team Response
• Trauma Team
 Trauma surgeon
 Emergency physician
 Anesthesiologist
 Trauma nurse
 Others