Status:
COMPLETED
Field Trial of Hypotensive Versus Standard Resuscitation for Hemorrhagic Shock After Trauma
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Canadian Institutes of Health Research (CIHR)
Conditions:
Blunt Trauma
Penetrating Wound
Eligibility:
All Genders
15+ years
Phase:
PHASE2
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...
Detailed Description
1. Overview This multi-center pilot trial is designed to determine the feasibility and safety of hypotensive resuscitation for the early resuscitation of patients with traumatic shock compared to stan...
Eligibility Criteria
Inclusion
- Included will be those with:
- Blunt or penetrating injury
- Age ≥15yrs or weight ≥50kg if age is unknown
- Prehospital SBP ≤ 90 mmHg
Exclusion
- Excluded will be those with:
- 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
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT01411852
Start Date
March 1 2012
End Date
April 1 2013
Last Update
January 13 2015
Active Locations (6)
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1
Alabama Resuscitation Center, University of Alabama
Birmingham, Alabama, United States, 35294
2
Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University
Portland, Oregon, United States, 97239
3
The Pittsburgh Resuscitation Network, University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15261
4
Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390