PreHospital Air Medical Plasma Trial (PAMPer)

Jason Sperry

Status and phase: Completed; Phase 3

Conditions: Hemmorhagic Shock During Air Medical Transport

Treatments: Biological: infusion of 2 units of plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT01818427

11152002 IND 15117

Details and patient eligibility

About

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.

Full 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.

Enrollment: 523 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Hemorrhagic shock not responsive to crystalloid infusion -

Exclusion Criteria: Isolated Fall, Cervical cord injury, prisoner, pregnant patient, traumatic arrest

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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523 participants in 2 patient groups

plasma

Experimental group

Description:

infusion of 2 units of plasma

Treatment:

Biological: infusion of 2 units of plasma

standard air medical care

No Intervention group

Description:

control group