Pre-Hospital Use of Plasma for Traumatic Hemorrhage

• Status: Withdrawn
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virginia Commonwealth University
• Collaborator: United States Department of Defense

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