The Hypotensive Resuscitation versus Standard Resuscitation Study (HypoResus)

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Traumatic Injuries,Bleeding Shock

• The Hypotensive Resuscitation versus Standard
  Resuscitation Study (HypoResus)

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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.

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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 hemorrhagesevere 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

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Deaths from Trauma

• Immediate50 (at scene)
• Massive brain or spinal injury, cardiovascular
  event
• Early30 (within first 24-48 hours)
• Severe brain injury, shock due to blood loss from
  torso trauma
• Late20 (days to weeks)
• Multiple organ failure and overwhelming infection
• Influenced by inadequate early resuscitation or
  care

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Field Management of Severe Blood Loss

• There are two major types of bleedinginternal
  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.

Tourniquet
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Treatment of Severe Blood Loss

• Traditional treatment for shock related tosevere
  blood loss is aggressive intravenous(IV) fluid
  administration.
• The purpose is to attempt to restore
  circulatingblood volume and an adequate blood
  pressure.
• Fluids used in the field are typically
  eithernormal saline (salt water solution) or
  LactatedRingers 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.

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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.

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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 Afghanistan.
• 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.

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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.

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Significance of the Research

• When internal bleeding occurs, blood clots form.
• It is the bodys 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.

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Significance of the Research continued

• Neither early aggressive administration of fluids
  in the field, nor minimal or no fluid
  administration has proven to be superior.
• 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 patients.

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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.

Simply we want to determine what is the BEST
treatment strategy for trauma patients suffering
severe blood loss.
Big Bag (1000 ml)
Small Bag (250 ml)
versus
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Study Fluids
Temporary photo until new kits available
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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.

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Eligibility for Enrollment
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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 roc_at_ohsu.edu
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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.

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Safety Monitoring

• The study will be monitored by
• Data Safety Monitoring Board (DSMB)an
  independent group
• Institutional Review Board (IRB)
• Food Drug Administration (FDA)
• National Institutes of Health (NIH)

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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 exception
• 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 exception.

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EFIC Regulations

• Require community input and commentary for the
  proposed research.
• 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.

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Questions?
Do you have any concerns regarding this proposed
research study?
For more information, visit our website
at www.ohsu.edu/emergency/roc
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Supplemental Slides To be used if questions about
heart attacks come up in the discussion.
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Who will be included in the study?
Patients Included
Patients Excluded

• Those with blunt or penetrating injuries
  (abrasions, lacerations, hematomas, etc.)
• Patients in shock (systolic blood pressure less
  than or equal to 90)
• Age greater than or equal to 15 years
• Or, if age unknown, a weight of greater than or
  equal to 50 kg
• Absence of severe head injury
• Or adequate level of consciousness

• Severe head injury
• Previous IV fluids given (gt250 ml)
• Ongoing prehospital CPR
• Known prisoners
• Known/suspected pregnancy
• Drowning or hanging
• Significant burns
• Time from dispatch gt4 hrs
• Blood pressure greater than 90
• Age less than 15 years
• Or weight lt50 kg, if age unknown

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Field Intervention Procedures
Run slowly (keep vein open)
Reassess SBP or radial pulse and repeat PRN
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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

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Portland-VancouverMetro 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 calls/year)

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Tri-County Level 1 Trauma Centers
Legacy EmanuelHospital Health Center
Oregon HealthSciences University
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Clark County Level II Trauma Center
Peace Health Southwest Medical Center
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Hospital Trauma Team Response

• Trauma Team
• Trauma surgeon
• Emergency physician
• Anesthesiologist
• Trauma nurse
• Others