Pre-Hospital Use of Plasma for Traumatic Hemorrhage (PUPTH)
Shock, Hemorrhagic
About this trial
This is an interventional treatment trial for Shock, Hemorrhagic focused on measuring Trauma, Hemorrhage, Plasma, Shock, Polytrauma
Eligibility Criteria
Inclusion Criteria:
- Blunt or penetrating trauma,
- Blood Pressure (BP) systolic <70 mmHg or BP 70-90 mmHg with Heart Rate (HR) > 108 Beats Per Minute (BPM),
- Ongoing hemorrhage with unstable vital signs
Exclusion Criteria:
- Wearing opt-out wrist band,
- Wearing medical alert jewelry / bracelet, etc. indicating Jehovah Witness or similar with objections to blood transfusions,
- Refusal to participate (by subject or LAR),
- Communication barrier at the time of eliciting refusal (non-English speaking or non-Spanish speaking),
- Not expected to survive transport to Virginia Commonwealth University Medical Center (VCUMC),
- Documented Do Not Resuscitate (DNR) order found,
- Cardiac arrest or Cardio-Pulmonary Resuscitation (CPR) prior to randomization
- Penetrating head trauma,
- Known / obvious pregnancy,
- Prisoner,
- Burns > 20% of body surface
Sites / Locations
- Virginia Commonwealth University
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Type A Thawed Plasma
Normal saline
Eligible subjects with polytrauma (PT) and major hemorrhage (MH) will be randomized to receive 2 units of thawed Type A plasma in the pre-hospital setting administered by EMS first responders. An exception from informed consent under 21CFR 50.24 is required since enrollment will occur (for the majority of subjects) before consent can be obtained.
Eligible subjects with polytrauma (PT) and major hemorrhage (MH) will be randomized to receive normal saline in the pre-hospital setting administered by EMS first responders. Normal saline is standard of care