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Hemorrhagic ShockPIPTNCT02821364

Philadelphia Immediate Transport in Penetrating Trauma Trial

A study testing Advanced Life Support in people with Hemorrhagic Shock and Peritonitis, run by Temple University at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hemorrhagic Shock, Peritonitis
What is being tested?
Advanced Life Support
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Feb 2020to 31 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

Other trials in United States

About this study

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.

Read the 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.

Being tested
Advanced Life Support
Medical subject headings
Shock, Hemorrhagic, Peritonitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Advanced Life SupportOther

    IV FLUIDS, INTUBATION

Study groups in NCT02821364
Study groupRoleWhat they receive
Advanced Life SupportOtherALS 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.
Receives: Other: Advanced Life Support
Basic Life SupportNo interventionSubjects 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survival to hospital discharge

    Mortality at 48 hours

    Measured: 48 hours

Secondary outcomes (5)
  1. Transfusion requirement

    Absence or presence of needing a transfusion

    Measured: 48 hours

  2. Ventilator days

    Absence or presence of needing a ventilator

    Measured: 48 hours

  3. Hospital & ICU length of stay

    Total time spent in hospital \& ICU

    Measured: 48 hours

  4. Cost of hospital admission

    Total cost of admission

    Measured: 48 hours

  5. Discharge disability

    Absence or presence of disability

    Measured: 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2016 (estimated)
  2. Study start1 Feb 2020
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Why it stopped: The study was not feasible due to logistical elements

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02821364
Sponsor's protocol ID
22749
Acronym
PIPT
Status last verified
Jul 2022
First submitted
13 Apr 2016
Last updated
28 Jul 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Advanced Life Support in people with Hemorrhagic Shock and Peritonitis, run by Temple University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival to hospital discharge (time frame: 48 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2022.

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