Pre-Hospital Use of Plasma for Traumatic Hemorrhage

Withdrawn before enrolling · Phase 2/Phase 3

Conditions studied: Shock, Hemorrhagic

In brief

Type A Thawed Plasma (TP) will be compared in polytrauma patients who receive only Normal Saline (NS) (standard of care) before arrival at the hospital. The purpose of this study is to determine if prehospital administration of thawed plasma can reduce mortality of patients who have lost a large amount of blood due to their injuries, compared to those receiving standard of care.

Key facts

Study ID

NCT02303964

Run by

Virginia Commonwealth University

People needed

0

Starts

2014-11-01

Expected to finish

2016-01-01

Last updated by the study team

2016-02-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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