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Philadelphia Immediate Transport in Penetrating Trauma Trial (PIPT)

Primary Purpose

Hemorrhagic Shock, Peritonitis

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Advanced Life Support
Sponsored by
Temple University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hemorrhagic Shock

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The investigators will include all penetrating trauma patients with shock over the age of 18.

  1. Penetrating injury (required)
  2. Combined torso and distal extremity injury
  3. Combined penetrating and blunt injury
  4. Heart rate greater than 100, systolic blood pressure less than 100 or mental status change (evidence of shock)

Exclusion Criteria:

Patients with any injuries above the clavicle or head injuries will be excluded. If known at the time of randomization the investigator will exclude all known minors under the age of 18, known pregnant women, and known prisoners. Patients with isolated blunt mechanism of injury such as motor vehicle accidents will be excluded. However, patients with combined blunt and penetrating torso injury will be included.

  1. Injury above the clavicle
  2. Isolated injury distal to the elbows or knees
  3. Known age <18, pregnant, or prisoner

Sites / Locations

  • Temple University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Advanced Life Support

Basic Life Support

Arm Description

ALS providers are trained and able to perform certain procedures such as intubation with endotracheal tubes and placement of intravenous catheters. Endotracheal intubation is often performed by pre-hospital providers in critically ill trauma patients because it is believed that it allows for protection of the airway and better delivery of oxygen. However, most studies actually show that intubation does not provide a survival advantage to this patient population and actually could result in worse outcomes. Intravenous catheter placement and administration of intravenous fluids is also routinely performed however, studies have shown that it is also not helpful.

Subjects randomized to the study group will receive basic life support (BLS) level care. This means that pre-hospital procedures such as endotracheal intubation and intravenous fluid administration will not be carried out. However, passive oxygen and needle thoracostomy, if required for tension pneumothorax, will be permitted if medically necessary.

Outcomes

Primary Outcome Measures

Survival to hospital discharge
Mortality at 48 hours

Secondary Outcome Measures

Transfusion requirement
Absence or presence of needing a transfusion
Ventilator days
Absence or presence of needing a ventilator
Hospital & ICU length of stay
Total time spent in hospital & ICU
Cost of hospital admission
Total cost of admission
Discharge disability
Absence or presence of disability

Full Information

First Posted
April 13, 2016
Last Updated
July 25, 2022
Sponsor
Temple University
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1. Study Identification

Unique Protocol Identification Number
NCT02821364
Brief Title
Philadelphia Immediate Transport in Penetrating Trauma Trial
Acronym
PIPT
Official Title
Philadelphia Immediate Transport in Penetrating Trauma Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Withdrawn
Why Stopped
The study was not feasible due to logistical elements
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Temple University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
PIPT Trial (Philadelphia Immediate Transport in Penetrating Trauma Trial) A prospective randomized clinical trial comparing pre-hospital procedures to immediate transportation in patients with penetrating injury and shock.
Detailed Description
The establishment of Advanced Life Support by emergency medical services (EMS) has led to an increasing number of procedures being carried out in the field. These procedures, such as intravenous (IV) fluid administration and endotracheal intubation can be beneficial in rural settings where transportation to definitive care is prolonged. In addition, it can provide benefit to patients with traumatic brain injury. However, data on field procedures carried out in penetrating trauma patients in urban locations is less convincing and actually shows that these procedures result in worse morbidity and mortality, where penetrating injury is defined as resulting from gunshot, shotgun or stab wounds. In fact, studies have shown that pre-hospital intubation clearly does not confer a survival advantage to penetrating trauma patients in urban locations. Yet pre-hospital procedures continue to be performed in urban Philadelphia on a regular basis. In a recently published study at Temple University Hospital from 2006-2010, of the 1,615 gunshot and stab wound victims that were highest level trauma activations, 152 (9.8%) were intubated in the field. In another study carried out at Temple University Hospital looking at the most critically ill penetrating trauma patients that required emergency room thoracotomy, 71.8% of patients transported by EMS were intubated and 67.0% received IV fluids. This demonstrates that these procedures are being carried out with regularity in severely injured penetrating trauma patients. Patient recruitment and randomization will occur at the time that the distress call is received by the EMS dispatcher and an ALS crew is dispatched. The dispatcher will assign the patient to advanced life support current practice or immediate transport with basic life support current practice based on even or odd dispatch number. All participating paramedics will be given face to face training in the conduct of the trial, and provided with resources for online refreshers and reminders. Compliance with enrollment procedures will be monitored through redundant mechanisms including notification at hospital arrival, cross referenced to monthly monitoring of EMS reports. Subjects randomized to the study group will receive basic life support (BLS) level care. This means that pre-hospital procedures such as endotracheal intubation and intravenous fluid administration will not be carried out. However, passive oxygen and needle thoracostomy, if required for tension pneumothorax, will be permitted if medically necessary. For patients in the control group, ALS responders will perform advanced life support current practice, including intravenous fluid administration and endotracheal intubation as deemed appropriate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhagic Shock, Peritonitis

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Advanced Life Support
Arm Type
Other
Arm Description
ALS providers are trained and able to perform certain procedures such as intubation with endotracheal tubes and placement of intravenous catheters. Endotracheal intubation is often performed by pre-hospital providers in critically ill trauma patients because it is believed that it allows for protection of the airway and better delivery of oxygen. However, most studies actually show that intubation does not provide a survival advantage to this patient population and actually could result in worse outcomes. Intravenous catheter placement and administration of intravenous fluids is also routinely performed however, studies have shown that it is also not helpful.
Arm Title
Basic Life Support
Arm Type
No Intervention
Arm Description
Subjects randomized to the study group will receive basic life support (BLS) level care. This means that pre-hospital procedures such as endotracheal intubation and intravenous fluid administration will not be carried out. However, passive oxygen and needle thoracostomy, if required for tension pneumothorax, will be permitted if medically necessary.
Intervention Type
Other
Intervention Name(s)
Advanced Life Support
Intervention Description
IV FLUIDS, INTUBATION
Primary Outcome Measure Information:
Title
Survival to hospital discharge
Description
Mortality at 48 hours
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Transfusion requirement
Description
Absence or presence of needing a transfusion
Time Frame
48 hours
Title
Ventilator days
Description
Absence or presence of needing a ventilator
Time Frame
48 hours
Title
Hospital & ICU length of stay
Description
Total time spent in hospital & ICU
Time Frame
48 hours
Title
Cost of hospital admission
Description
Total cost of admission
Time Frame
48 hours
Title
Discharge disability
Description
Absence or presence of disability
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The investigators will include all penetrating trauma patients with shock over the age of 18. Penetrating injury (required) Combined torso and distal extremity injury Combined penetrating and blunt injury Heart rate greater than 100, systolic blood pressure less than 100 or mental status change (evidence of shock) Exclusion Criteria: Patients with any injuries above the clavicle or head injuries will be excluded. If known at the time of randomization the investigator will exclude all known minors under the age of 18, known pregnant women, and known prisoners. Patients with isolated blunt mechanism of injury such as motor vehicle accidents will be excluded. However, patients with combined blunt and penetrating torso injury will be included. Injury above the clavicle Isolated injury distal to the elbows or knees Known age <18, pregnant, or prisoner
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Goldberg, MD
Organizational Affiliation
Temple University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Philadelphia Immediate Transport in Penetrating Trauma Trial

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