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Trial record 1 of 1 for:    PAMPer
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PreHospital Air Medical Plasma Trial (PAMPer)

This study has been completed.
Sponsor:
Collaborators:
University of Texas
University of Louisville
Vanderbilt University
Case Western Reserve University
The University of Tennessee, Knoxville
JPS Health Network
The Methodist Hospital System
Information provided by (Responsible Party):
Jason Sperry, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01818427
First received: March 19, 2013
Last updated: September 14, 2017
Last verified: September 2017
  Purpose
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.

Condition Intervention Phase
Hemmorhagic Shock During Air Medical Transport Biological: infusion of 2 units of plasma Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Prehospital Air Medical Plasma (PAMPer) Phase III Multicenter, Prospective, Randomized, Open-label, Interventional Trial A Four Year Multicenter Open Label Randomized Trial

Resource links provided by NLM:


Further study details as provided by Jason Sperry, University of Pittsburgh:

Primary Outcome Measures:
  • Our primary outcome for the proposal will be 30 day mortality [ Time Frame: 30 days ]
    All cause mortality.


Secondary Outcome Measures:
  • Twenty Four-Hour Blood Transfusion Requirements [ Time Frame: at twenty four hours ]
    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.

  • In-hospital mortality [ Time Frame: during hospitalization ]
    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.

  • Multiple organ failure [ Time Frame: during hospitalization ]
    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.

  • Acute lung injury (ALI) and Transfusion Related Acute Lung Injury (TRALI) [ Time Frame: hospitalization ]
    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.


Enrollment: 563
Study Start Date: May 2014
Study Completion Date: September 2017
Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: plasma
infusion of 2 units of plasma
Biological: infusion of 2 units of plasma
infusion of 2 units of plasma
No Intervention: standard air medical care
control group

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Hemorrhagic shock not responsive to crystalloid infusion -

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01818427

Locations
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
University of Texas
University of Louisville
Vanderbilt University
Case Western Reserve University
The University of Tennessee, Knoxville
JPS Health Network
The Methodist Hospital System
Investigators
Principal Investigator: Jason L Sperry, MD,MPH University of Pittsburgh
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jason Sperry, MD, MPH, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01818427     History of Changes
Other Study ID Numbers: 11152002 IND 15117
Study First Received: March 19, 2013
Last Updated: September 14, 2017

Keywords provided by Jason Sperry, University of Pittsburgh:
hemmorhagic shock, plasma, air medical transport, randomized, multicenter

ClinicalTrials.gov processed this record on September 21, 2017