Taking the Blood Bank to the Field: The Design and Rationale of the Prehospital Air Medical Plasma (PAMPer) Trial

Abstract

Hemorrhage and trauma induced coagulopathy remain major drivers of early preventable mortality in military and civilian trauma. Interest in the use of prehospital plasma in hemorrhaging patients as a primary resuscitation agent has grown recently. Trauma center-based damage control resuscitation using early and aggressive plasma transfusion has consistently demonstrated improved outcomes in hemorrhaging patients. Additionally, plasma has been shown to have several favorable immunomodulatory effects. Preliminary evidence with prehospital plasma transfusion has demonstrated feasibility and improved short-term outcomes. Applying state-of-the-art resuscitation strategies to the civilian prehospital arena is compelling. We describe here the rationale, design, and challenges of the Prehospital Air Medical Plasma (PAMPer) trial. The primary objective is to determine the effect of prehospital plasma transfusion during air medical transport on 30-day mortality in patients at risk for traumatic hemorrhage. This study is a multicenter cluster randomized clinical trial. The trial will enroll trauma patients with profound hypotension (SBP ≤ 70 mmHg) or hypotension (SBP 71–90 mmHg) and tachycardia (HR ≥ 108 bpm) from six level I trauma center air medical transport programs. The trial will also explore the effects of prehospital plasma transfusion on the coagulation and inflammatory response following injury. The trial will be conducted under exception for informed consent for emergency research with an investigational new drug approval from the U.S. Food and Drug Administration utilizing a multipronged community consultation process. It is one of three ongoing Department of Defense-funded trials aimed at expanding our understanding of the optimal therapeutic approaches to coagulopathy in the hemorrhaging trauma patient.

Prehospital plasma resuscitation associated with improved neurologic outcomes after traumatic brain injury

“…Evaluation of the ongoing studies will provide an important foundation for transfusion strategies (11–12). These studies may identify or posit additional questions for the determination of the optimal plasma:blood transfusion ratio in patients with hemorrhagic shock and TBI.…”

“…Large animal data suggest that the early resuscitation with plasma in combined TBI and hemorrhagic shock models may improve neurologic outcomes(7–10). In order to address these gaps in our TBI resuscitation approach, studies are underway evaluating crystalloid versus blood products in patients with hemorrhagic shock and TBI (11,12). More study is needed regarding the effects of coagulopathy and TBI in patients with multisystem trauma (13).…”

The need for dried plasma – a national issue

“…Prehospital administration of plasma resulted in a significantly lower 30‐day mortality (23.2% vs. 33.0%; p = 0.03), compared to the standard‐of‐care group. No differences between groups were noted in transfusion‐related adverse events …”

Optimal Fluid Therapy for Traumatic Hemorrhagic Shock

“…85 Although there was no mortality benefit in all patients, prehospital plasma transfusion was associated with decreased mortality in the most critically ill patients (those admitted directly to the ICU, IR, OR, or morgue). Randomized trials to study the impact of prehospital plasma in ground 86 and aeromedical transport 87 are on-going.…”