Field Trial of Hypotensive Versus Standard Resuscitation for Hemorrhagic Shock After Trauma

NCT01411852 | Completed Phase 2 Results DMC

• 2 other identifiers: 41071-B5U01HL077863-07
• Study Type: interventional
• Target: 192
• Locations: 2 countries
• Sites: 6

Brief Summary

Primary Aim: To determine the feasibility and safety of hypotensive resuscitation for the early treatment of patients with traumatic shock compared to standard fluid resuscitation. Primary Hypotheses: The null hypothesis regarding feasibility is that hypotensive resuscitation will result in the same volume of early crystalloid (normal saline) fluid administration compared to standard crystalloid resuscitation. The null hypothesis regarding safety is that hypotensive resuscitation will result in the same percent of patients surviving to 24 hours after 911 call received at dispatch compared to standard fluid resuscitation. Early resuscitation is defined as all fluid given until 2 hours after arrival in the Emergency Department or until hemorrhage control is achieved in the hospital, whichever occurs earlier.

Conditions

Blunt Trauma; Penetrating Wound; Hemorrhagic Shock

Keywords

fluid volume resuscitation; trauma; hemorrhagic shock

Outcome Measures

Primary Outcomes (2)

• Total Volume of All Crystalloid Given for Early Resuscitation (Feasibility)

  The primary feasibility endpoint was early crystalloid volume (ECV) defined as crystalloid infused from Emergency Medical Services (EMS) arrival at the scene until the end of the study period

  From time of first intravenous or intraosseous insertion through the first 2 hours after hospital arrival or hemorrhage control, which ever occurs first

• 24 Hour Mortality

  The 24 hour mortality endpoint for the total number of patients each arm

  From time of hospital arrival through the first 24 hours

Secondary Outcomes (17)

• Number of Ineligible Patients Enrolled at the Time of Randomization

  From the time the paramedic with study drug kit arrived at patient's side to the time kit was opened prior to ED arrival

• Total Fluid Requirement During First 24 Hours

  From ED arrival through the first 24 hours

• Total Blood Product Requirements in First 24 Hours

  From ED arrival through the first 24 hours

• Base Deficit on Admission to the Emergency Department (ED)

  From final Emergency Department arrival time through first 24 hours

• Hemoglobin on Admission to the Emergency Department

  From final Emergency Department arrival time through first 24 hours

Study Arms (2)

0.9% Sodium Chloride 250 mL bolus

EXPERIMENTAL

0.9% Sodium Chloride 250 mL bolus - A large bore IV will be placed and a 250cc bag of normal saline (NS) will be hung. If IV placement is difficult, NS can be given through an intraosseous line. Using small bags versus large bags will physically limit the amount of fluid given to patients in the experimental group. The requirement to change the smaller bags of fluid and recheck the pulse or blood pressure will limit the amount of fluid given. The procedure will continue until 2 hours after arrival to the hospital or until hemorrhage control is achieved whichever occurs first. Hemorrhage control will be defined as ligation of a bleeding vessel, packing of a solid organ, removal of a solid organ, and angiographic embolization of a bleeding vessel.

Drug: 0.9% Sodium Chloride 250 mL bolus

0.9% Sodium Chloride 2000 mL bolus

ACTIVE COMPARATOR

0.9% Sodium Chloride 2000 mL bolus - The treatment of the control group will be consistent with traditional Prehospital Trauma Life Support and Advanced Trauma Life Support guidelines which recommend early aggressive fluid resuscitation. An intravenous line (IV) will be placed and a 1000cc bag of normal saline will be hung. If IV placement is difficult, fluid can be given through an intraosseous line. This procedure will continue until either 2 hours after hospital arrival or until control of hemorrhage is achieved whichever occurs first. Hemorrhage control will be defined as ligation of a bleeding vessel, packing of a solid organ, removal of a solid organ, and angiographic embolization of a bleeding vessel.

Drug: 0.9% Sodium Chloride 2000 mL bolus

Interventions

0.9% Sodium Chloride 250 mL bolus DRUG

Emergency Medicine Systems (EMS) agencies and in-hospital providers will be given the option to utilize either systolic blood pressure (SBP) or radial pulse as the endpoint for fluid resuscitation to patients randomized to the experimental group. Patients will receive a 250 ml bolus of normal saline (NS) only if the SBP is less than 70 mmHg or the radial pulse is not palpable. If the SBP is greater than or equal to 70 mmHg or the radial pulse is palpable, NS will be given to keep the vein open. The presence or absence of a radial pulse or the SBP will be documented before and after each bolus. The study will continue repeating the randomization procedure using only 250 ml bags of NS until 2 hours after arrival to the hospital or until hemorrhage control is achieved whichever occurs first.

Also known as: isotonic saline, normal saline

0.9% Sodium Chloride 250 mL bolus

0.9% Sodium Chloride 2000 mL bolus DRUG

Emergency Medicine Systems (EMS) personnel and in-hospital providers will utilize the systolic blood pressure SBP as the endpoint for delivering fluid resuscitation to patients randomized to the control group. If the SBP is equal to or less than 90 mmHg, the EMS personnel will start infusing a 1000 ml bolus of normal saline (NS) and will continue using only 1000 ml bags of NS as needed. If the total fluid resuscitation exceeds 2 liters, fluid will be stopped when the SBP exceeds 110 mmHg and restarted as necessary to maintain a goal SBP of 110 mmHg. The fluid will be given as rapidly as possible. This fluid resuscitation protocol will continue until either 2 hours after hospital arrival or until control of hemorrhage is achieved whichever occurs first.

Also known as: isotonic saline, normal saline

0.9% Sodium Chloride 2000 mL bolus

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Blunt or penetrating injury
• Age ≥15yrs or weight ≥50kg if age is unknown
• Prehospital SBP ≤ 90 mmHg

You may not qualify if:

• Ground level falls
• Evidence of severe blunt or penetrating head injury with a Glasgow Coma Scale (GCS) ≤ 8
• Bilateral paralysis secondary to suspected spinal cord injury
• Fluid greater than 250ml was given prior to randomization
• Cardiopulmonary resuscitation (CPR) by Emergency Medicine Service (EMS) prior to randomization
• Known prisoners
• Known or suspected pregnancy
• Drowning or asphyxia due to hanging
• Burns over a Total Body Surface Area (TBSA) \> 20%
• Time of call received at dispatch to study intervention \> 4 hours

Sponsors & Collaborators

• University of Washington: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (6)

Alabama Resuscitation Center, University of Alabama

Birmingham, Alabama, 35294, United States

Location

Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University

Portland, Oregon, 97239, United States

Location

The Pittsburgh Resuscitation Network, University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Milwaukee Resuscitation Network, Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Resuscitation Outcomes Consortium Regional Coordinating Center,University of British Columbia

Vancouver, British Columbia, V5Z 1M9, Canada

Location

MeSH Terms

Conditions

Wounds, Nonpenetrating; Wounds, Penetrating; Shock, Hemorrhagic; Wounds and Injuries

Interventions

Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

One patient was determined to have been in police custody at the time of enrollment, which was a protocol violation. This patient was randomized to the controlled resuscitation group but was not included in the primary or secondary outcome analyses.

Results Point of Contact

• Title: Susanne May, PhD, Principal Investigator
• Organization: Resuscitation Outcomes Consortium

sjmay@uw.edu

206-685-1302

Study Officials

• Myron L Weisfeldt, MD

  Resuscitation Outcomes Consortium

  STUDY CHAIR

• David Hoyt, MD

  Resuscitation Outcomes Consortium

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD/Principal Investigator, Resuscitation Outcomes Consortium Data Coordinating Center

Study Record Dates

• First Submitted: August 3, 2011
• First Posted: August 8, 2011
• Study Start: March 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: January 13, 2015
• Results First Posted: October 20, 2014

Record last verified: 2014-12

Locations

CA (1); US (5)