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The Hypotensive Resuscitation versus Standard Resuscitation Study (HypoResus)

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Traumatic Injuries, Bleeding & Shock The Hypotensive Resuscitation versus Standard Resuscitation Study (HypoResus) Trauma Team Trauma surgeon Emergency physician ... – PowerPoint PPT presentation

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Title: The Hypotensive Resuscitation versus Standard Resuscitation Study (HypoResus)


1
Traumatic Injuries, Bleeding Shock
  • The Hypotensive Resuscitation versus Standard
    Resuscitation Study (HypoResus)

2
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.

3
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

4
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

5
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.

Tourniquet
6
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 Ringers 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.

7
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.

8
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.

9
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.

10
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.

11
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.

12
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
13
Study Fluids
Temporary photo until new kits available
14
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.

15
Eligibility for Enrollment
16
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
17
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.

18
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)

19
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.

20
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.

21
Questions?
Do you have any concerns regarding this proposed
research study?
For more information, visit our website
at www.ohsu.edu/emergency/roc
22
Supplemental Slides To be used if questions about
heart attacks come up in the discussion.
23
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

24
Field Intervention Procedures
Run slowly (keep vein open)
Reassess SBP or radial pulse and repeat PRN
25
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-Vancouver 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 calls/year)

32
Tri-County Level 1 Trauma Centers
Legacy Emanuel Hospital Health Center
Oregon Health Sciences University
33
Clark County Level II Trauma Center
Peace Health Southwest Medical Center
34
Hospital Trauma Team Response
  • Trauma Team
  • Trauma surgeon
  • Emergency physician
  • Anesthesiologist
  • Trauma nurse
  • Others
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