Philadelphia Immediate Transport in Penetrating Trauma Trial

NCT02821364 | Withdrawn DMC

• 1 other identifier: 22749
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemorrhagic Shock; Peritonitis

Outcome Measures

Primary Outcomes (1)

• Survival to hospital discharge

  Mortality at 48 hours

  48 hours

Secondary Outcomes (5)

• Transfusion requirement

  48 hours

• Ventilator days

  48 hours

• Hospital & ICU length of stay

  48 hours

• Cost of hospital admission

  48 hours

• Discharge disability

  48 hours

Study Arms (2)

Advanced Life Support

OTHER

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.

Other: Advanced Life Support

Basic Life Support

NO INTERVENTION

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.

Interventions

Advanced Life Support OTHER

IV FLUIDS, INTUBATION

Advanced Life Support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Temple University: lead

Study Sites (1)

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

Shock, Hemorrhagic; Peritonitis

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Intraabdominal Infections; Infections; Peritoneal Diseases; Digestive System Diseases

Study Officials

• Amy Goldberg, MD

  Temple University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2016
• First Posted: July 1, 2016
• Study Start: February 1, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2025
• Last Updated: July 28, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)