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| Name | Class |
|---|---|
| University of Texas | OTHER |
| University of Louisville | OTHER |
| Vanderbilt University | OTHER |
| Case Western Reserve University |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| plasma | Experimental | infusion of 2 units of plasma |
|
| standard air medical care | No Intervention | control group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| infusion of 2 units of plasma | Biological | infusion of 2 units of plasma |
|
| 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 |
| 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. |
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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
-
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| Name | Affiliation | Role |
|---|---|---|
| Jason L Sperry, MD,MPH | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38933603 | Derived | Lorence JM, Donohue JK, Iyanna N, Guyette FX, Gimbel E, Brown JB, Daley BJ, Eastridge BJ, Miller RS, Nirula R, Harbrecht BG, Claridge JA, Phelan HA, Vercruysse G, O'Keeffe T, Joseph B, Neal MD, Sperry JL. Characterization of adverse events in injured patients at risk of hemorrhagic shock: a secondary analysis of three harmonized prehospital randomized clinical trials. Trauma Surg Acute Care Open. 2024 Jun 25;9(1):e001465. doi: 10.1136/tsaco-2024-001465. eCollection 2024. | |
| 35861072 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Plasma | infusion of 2 units of plasma infusion of 2 units of plasma: infusion of 2 units of plasma |
| FG001 | Standard Air Medical Care | control group |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
22 patients total, 8 in the plasma arm and 12 in the standard care arm withdrew consent and 1 patient in each arm was a prisoner and could not be included in the analysis cohort
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| ID | Title | Description |
|---|---|---|
| BG000 | Plasma | infusion of 2 units of plasma infusion of 2 units of plasma: infusion of 2 units of plasma |
| BG001 | Standard Air Medical Care | control group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 10 patients in each arm were lost to follow-up for 30-day mortality and 22 patients total, 8 in the plasma arm and 12 in the standard care arm withdrew consent and 1 patient in each arm was a prisoner and could not be included in the analysis cohort. We compared 30-day mortality using a two sided pooled z test with continuity correction. | Posted | Count of Participants | Participants | 30 days |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Plasma | infusion of 2 units of plasma infusion of 2 units of plasma: infusion of 2 units of plasma |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| tranfusion-related reaction | Blood and lymphatic system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| allergic reation | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jason Sperry | University of Pittsburgh | 412 6922850 | sperryjl@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 17, 2017 | Apr 30, 2018 | Prot_SAP_000.pdf |
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| OTHER |
| The University of Tennessee, Knoxville | OTHER |
| JPS Health Network | OTHER |
| The Methodist Hospital Research Institute | OTHER |
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| 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 |
| Derived |
| Wu J, Moheimani H, Li S, Kar UK, Bonaroti J, Miller RS, Daley BJ, Harbrecht BG, Claridge JA, Gruen DS, Phelan HA, Guyette FX, Neal MD, Das J, Sperry JL, Billiar TR. High Dimensional Multiomics Reveals Unique Characteristics of Early Plasma Administration in Polytrauma Patients With TBI. Ann Surg. 2022 Oct 1;276(4):673-683. doi: 10.1097/SLA.0000000000005610. Epub 2022 Jul 19. |
| 33057642 | Derived | Gruen DS, Guyette FX, Brown JB, Okonkwo DO, Puccio AM, Campwala IK, Tessmer MT, Daley BJ, Miller RS, Harbrecht BG, Claridge JA, Phelan HA, Neal MD, Zuckerbraun BS, Yazer MH, Billiar TR, Sperry JL. Association of Prehospital Plasma With Survival in Patients With Traumatic Brain Injury: A Secondary Analysis of the PAMPer Cluster Randomized Clinical Trial. JAMA Netw Open. 2020 Oct 1;3(10):e2016869. doi: 10.1001/jamanetworkopen.2020.16869. |
| 32229722 | Derived | Gruen DS, Brown JB, Guyette FX, Vodovotz Y, Johansson PI, Stensballe J, Barclay DA, Yin J, Daley BJ, Miller RS, Harbrecht BG, Claridge JA, Phelan HA, Neal MD, Zuckerbraun BS, Billiar TR, Sperry JL; PAMPer study group. Prehospital plasma is associated with distinct biomarker expression following injury. JCI Insight. 2020 Apr 23;5(8):e135350. doi: 10.1172/jci.insight.135350. |
| 31851290 | Derived | Pusateri AE, Moore EE, Moore HB, Le TD, Guyette FX, Chapman MP, Sauaia A, Ghasabyan A, Chandler J, McVaney K, Brown JB, Daley BJ, Miller RS, Harbrecht BG, Claridge JA, Phelan HA, Witham WR, Putnam AT, Sperry JL. Association of Prehospital Plasma Transfusion With Survival in Trauma Patients With Hemorrhagic Shock When Transport Times Are Longer Than 20 Minutes: A Post Hoc Analysis of the PAMPer and COMBAT Clinical Trials. JAMA Surg. 2020 Feb 1;155(2):e195085. doi: 10.1001/jamasurg.2019.5085. Epub 2020 Feb 19. |
| 30044935 | Derived | Sperry JL, Guyette FX, Brown JB, Yazer MH, Triulzi DJ, Early-Young BJ, Adams PW, Daley BJ, Miller RS, Harbrecht BG, Claridge JA, Phelan HA, Witham WR, Putnam AT, Duane TM, Alarcon LH, Callaway CW, Zuckerbraun BS, Neal MD, Rosengart MR, Forsythe RM, Billiar TR, Yealy DM, Peitzman AB, Zenati MS; PAMPer Study Group. Prehospital Plasma during Air Medical Transport in Trauma Patients at Risk for Hemorrhagic Shock. N Engl J Med. 2018 Jul 26;379(4):315-326. doi: 10.1056/NEJMoa1802345. |
| 26220293 | Derived | Reynolds PS, Michael MJ, Cochran ED, Wegelin JA, Spiess BD. Prehospital use of plasma in traumatic hemorrhage (The PUPTH Trial): study protocol for a randomised controlled trial. Trials. 2015 Jul 30;16:321. doi: 10.1186/s13063-015-0844-5. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
control group |
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | units of blood | at twenty four hours |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | during hospitalization |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | during hospitalization |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | hospitalization |
|
|
|
| 53 |
| 220 |
| 1 |
| 220 |
| 5 |
| 220 |
| EG001 | Standard Air Medical Care | control group | 89 | 261 | 2 | 261 | 2 | 261 |
| sepsis | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| adult respirator distress syndrome | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Anaphylaxis | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| fever | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| hypotension | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| pain | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| urticaria | Blood and lymphatic system disorders | Non-systematic Assessment |
|
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