Control of Major Bleeding After Trauma Study
| Status: | Terminated |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/10/2019 |
| Start Date: | April 7, 2014 |
| End Date: | April 3, 2017 |
A Prospective, Randomized Comparison of Fresh Frozen Plasma Versus Standard Crystalloid Intravenous Fluid as Initial Resuscitation Fluid
Bleeding is the most avoidable cause of death in trauma patients. Up to one-third of severely
injured trauma patients are found to be coagulopathic and forty percent of the mortality
following severe injury is due to uncontrollable hemorrhage in the setting of coagulopathy.
It has been established that early administration of fresh frozen plasma decreases mortality
following severe injury, replacing lost coagulation factors, improving the coagulopathy and
restoring blood volume. This study will determine if giving plasma to severely injured trauma
patients during ambulance transport versus after arrival to the hospital will help reduce
hemorrhage, thus decreasing both total blood product administration and mortality.
injured trauma patients are found to be coagulopathic and forty percent of the mortality
following severe injury is due to uncontrollable hemorrhage in the setting of coagulopathy.
It has been established that early administration of fresh frozen plasma decreases mortality
following severe injury, replacing lost coagulation factors, improving the coagulopathy and
restoring blood volume. This study will determine if giving plasma to severely injured trauma
patients during ambulance transport versus after arrival to the hospital will help reduce
hemorrhage, thus decreasing both total blood product administration and mortality.
Study Design: Severely injured trauma patients with a systolic blood pressure (SBP) ≤ 70 or
SBP ≤ 90 with a heart rate ≥ 108 bpm at the scene will be enrolled and randomized to receive
either 2 units of frozen plasma thawed in the field or normal saline (the current standard of
care), as the initial resuscitation fluid. After this initial resuscitation fluid, both
groups will receive the same standard of care, including packed red blood cells, additional
normal saline, or plasma as needed based on laboratory and clinical evidence of coagulopathy.
Blood samples and clinical information will be collected throughout the hospital stay up to
28 days after injury.
SBP ≤ 90 with a heart rate ≥ 108 bpm at the scene will be enrolled and randomized to receive
either 2 units of frozen plasma thawed in the field or normal saline (the current standard of
care), as the initial resuscitation fluid. After this initial resuscitation fluid, both
groups will receive the same standard of care, including packed red blood cells, additional
normal saline, or plasma as needed based on laboratory and clinical evidence of coagulopathy.
Blood samples and clinical information will be collected throughout the hospital stay up to
28 days after injury.
Inclusion Criteria:
- Age>=18 years
- Acutely injured
- SBP<70 mmHg or SBP 71-90 mmHg with heart rate (HR)>108 beats per minute.
Exclusion Criteria:
- Visibly or verbally reported pregnant women
- known prisoners
- unsalvageable injuries (defined as asystolic or cardiopulmonary resuscitation prior to
randomization)
- known objection to blood products
- the patient has an opt-out bracelet or, necklace or wallet card
- a family member present at the scene objects to the patient's enrollment in research.
We found this trial at
1
site
777 Bannock St
Denver, Colorado 80204
Denver, Colorado 80204
(303) 436-6000
Principal Investigator: Ernest E Moore, MD
Phone: 303-602-1820
Denver Health Medical Center Denver Health is a comprehensive, integrated organization providing level one care...
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