PreHospital Air Medical Plasma Trial

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hemmorhagic Shock During Air Medical Transport

Intervention / Treatment
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* Biological: infusion of 2 units of plasma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hemorrhagic shock not responsive to crystalloid infusion - Exclusion Criteria: Isolated Fall, Cervical cord injury, prisoner, pregnant patient, traumatic arrest -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: plasma<br>infusion of 2 units of plasma | Biological: infusion of 2 units of plasma<br>* infusion of 2 units of plasma<br>|
| No Intervention: standard air medical care<br>control group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Our Primary Outcome for the Proposal Will be 30 Day Mortality | All cause 30 day mortality using imputation for those with missing 30 day mortality. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Twenty Four-Hour Blood Transfusion Requirements | 24-hour blood transfusion requirements will be determined by recording blood volume (mls) and number of Units transfused from the time of trauma bay arrival or upon completion of pre-hospital initiated plasma infusion. For survival bias analysis, volumes and number of blood transfusion Units received at 3, 6, 12, and 18 hours will also be recorded. | at twenty four hours | 
| In-hospital Mortality | In hospital mortality will be prospectively recorded from the time of trauma bay arrival. Over the first 24 hours we will document and record the time of death in hours, while after the 24 hour time point, we will document and record the time of death in days from arrival. We suspect that patients in hemorrhagic shock will have a significant percentage of mortality occurring in the first 24 hour period. | during hospitalization | 
| Multiple Organ Failure | Organ dysfunction will be evaluated via a well-validated scoring system referred to as the Multiple Organ Dysfunction Score (MODScore). Patients who are never admitted to the ICU or those with a length of ICU stay of less than 48 hours will be considered to have a MODScore of 0. A summary of the MODScore may be calculated by summing the worst scores of each of the individual systems over the course of the ICU stay (Table 1). A summary MODScore > 5 will be classified as multiple organ failure (MOF). Scores will be determined daily up until post injury day 28 or ICU discharge. | during hospitalization | 
| Acute Lung Injury (ALI) and Transfusion Related Acute Lung Injury (TRALI) | Development of ALI will be assessed which includes: 1) bilateral infiltrates on chest x-ray, 2) a capillary wedge pressure < 18mmHg, and 3) Pao2/Fio2 ratio < 300 via blood gas analysis. In those patients without a Swan-Ganz catheter to determine capillary wedge pressure, the absence of signs of, or clinical concern, for elevated left sided atrial pressures will be used for the diagnosis. All patients who remain intubated beyond the first 24 hours post-injury will be evaluated using blood gas analysis and chest x-ray evaluation. Those patients who remain intubated at 48 hours through 7 days will be reevaluated for this outcome at these time points. The diagnosis of TRALI will be defined as when ALI occurs within the first 6 hours from arrival at the trauma center as it is clinically defined. | hospitalization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemmorhagic shock, plasma, air medical transport, randomized, multicenter