1. PORTLAND RESUSCITATION OUTCOMES CONSORTIUM The Hypotensive Resuscitation versus Standard Resuscitation Study (HypoResus) Traumatic Injuries, Bleeding & Shock

2. 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. What is this forum about?

3. 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 Traumatic Injuries

4. 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 Deaths from Trauma

5. 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. Field Management of Severe Blood Loss Tourniquet

6. 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. Treatment of Severe Blood Loss

7. 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

8. 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. Current Science & Studies continued…

9. 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. Current Science & Studies continued…

10. 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

11. 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. Significance of the Research continued…

12. 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. Goal of the HypoResus Study 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. 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. Study Design

15. Eligibility for Enrollment

16. Will be provided if desired. A “No Study” bracelet will be provided for those who request one. “Opt-Out” Option *To request a bracelet, call: 503-494-8083 or email roc@ohsu.edu

17. 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. Notification & Consent

18. 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) Safety Monitoring

19. 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. What is Exception from Informed Consent (EFIC)

20. 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. EFIC Regulations

21. Questions? For more information, visit our website at: www.ohsu.edu/emergency/roc Do you have any concerns regarding this proposed research study?

22. Supplemental Slides To be used if questions about heart attacks come up in the discussion.

23. Who will be included in the study? 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 (>250 ml) Ongoing prehospital CPR Known prisoners Known/suspected pregnancy Drowning or hanging Significant burns Time from dispatch >4 hrs Blood pressure greater than 90 Age less than 15 years  Or weight <50 kg, if age unknown Patients IncludedPatients Excluded

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

25. 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 Trauma Prevention

31. 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) Portland-Vancouver Metro EMS System

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. Trauma Team  Trauma surgeon  Emergency physician  Anesthesiologist  Trauma nurse  Others Hospital Trauma Team Response