NCT01838863

Control of Major Bleeding After Trauma Study

A Prospective, Randomized Comparison of Fresh Frozen Plasma Versus Standard Crystalloid Intravenous Fluid as Initial Resuscitation Fluid

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: Denver Health and Hospital Authority · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Trauma
• Hemorrhagic Shock

Interventions

Type	Name	Description
BIOLOGICAL	Type AB plasma	The plasma is thawed and administered to subjects in the experimental (plasma) arm.
DRUG	Crystalloid fluid (standard of care for resuscitation)	Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid

Timeline

• Start date: 2014-04-07
• Primary completion: 2017-04-03
• Completion: 2017-04-03
• First posted: 2013-04-24
• Last updated: 2019-01-08
• Results posted: 2018-07-18

Locations

1 site across 1 country: United States