Clinical trial NCT02821364: Philadelphia Immediate Transport in Penetrating Trauma Trial
Official title: Philadelphia Immediate Transport in Penetrating Trauma Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hemorrhagic Shock
Peritonitis
Lead sponsor: Temple University
Sponsor class: OTHER
First posted: 2016-07-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Survival to hospital discharge
timeFrame: 48 hours
Secondary outcomes:
measure: Transfusion requirement
timeFrame: 48 hours
measure: Ventilator days
timeFrame: 48 hours
measure: Hospital & ICU length of stay
timeFrame: 48 hours
measure: Cost of hospital admission
timeFrame: 48 hours
measure: Discharge disability
timeFrame: 48 hours
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
Study officials:
affiliation: Temple University Hospital
name: Amy Goldberg, MD
role: PRINCIPAL_INVESTIGATOR
References: