NCT01818427

PreHospital Air Medical Plasma Trial

Prehospital Air Medical Plasma (PAMPer) Phase III Multicenter, Prospective, Randomized, Open-label, Interventional Trial A Four Year Multicenter Open Label Randomized Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 523 (actual)
• Sponsor: Jason Sperry · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

To determine the effect of the prehospital infusion during air transport of 2 units of AB plasma on 30 day mortality in patients with hemorrhagic shock as compared to conventional care.

Detailed description

Background: Although advances in the care of the severely injured patient have occurred over the last decade, patients continue to be plagued with uncontrolled hemorrhage resulting in significant early mortality and the development of multiple organ failure and associated complications. A primary driving force for this unbridled hemorrhage has been shown to be the early coagulopathy which complicates severe injury. Increasing evidence suggests that blood component transfusion protocols that address this early coagulopathy, once a patient arrives at a trauma center, are associated with lower mortality and a reduction in blood component transfusion requirements. Prehospital interventions which quell this early coagulopathy in an earlier setting have the potential to minimize or even prevent this vicious hemorrhagic cascade, further lowering blood component transfusion requirements and reducing the resultant morbid sequelae which complicates severe injury. Objective/Hypothesis: The primary hypothesis will be that prehospital infusion of plasma during air medical transport in patients with hemorrhagic shock will lower 30 day mortality. The secondary hypotheses include that prehospital infusion of plasma will reduce 24 hour blood transfusion, multiple organ failure, nosocomial infection, and acute lung injury, reduce or prevent the early coagulopathy as demonstrated by improving presenting coagulation and thromboelastography parameters, and reduce the early inflammatory cytokine response, thrombomodulin and increase protein C levels.

Conditions

• Hemmorhagic Shock During Air Medical Transport

Interventions

Type	Name	Description
BIOLOGICAL	infusion of 2 units of plasma	infusion of 2 units of plasma

Timeline

• Start date: 2014-05-01
• Primary completion: 2017-09-01
• Completion: 2017-09-01
• First posted: 2013-03-26
• Last updated: 2021-04-08
• Results posted: 2018-10-09

Locations

1 site across 1 country: United States