Skip to main content
OpenTrials
Completed

NCT Number: NCT06402669

Extremity Trauma At a Level 1 Trauma Center

Blunt vascular trauma to the lower extremity has been associated with injuries to the anteroposterior tibial arteries or popliteal artery in the form of transection, occlusion, or intimal injury. With many blunt injuries resulting in orthopedic fractures, the incidence of limb loss increases substantial. Distal vascular injuries combined with complex orthopedic fractures are more likely to result in limb loss. A recent retrospective study showed two main predicative factors resulting in limb loss was a result of multi-segmental bone fractures and prolong ischemic time greater then 10 hours.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Arrowhead Regional Medical Center

Colton, California, 92324, United States

About this study

Extremity trauma continues to remain a notable cause for presentation to the emergency department for trauma-level care, with penetrating extremity injuries comprising 5 to 15% of trauma cases. In the setting of vascular extremity injury, appropriate care protocols must be established to prevent life threatening complications including infection, non-union, limb salvage failure, and death. The two primary mechanisms of extremity trauma include penetrating trauma involving projectile and stab injuries, as well as blunt trauma involving fractures and joint dislocations. While central or peripheral vascular injuries constitute 1-2% of traumatic injuries, they result in more than 20% of trauma-related mortality demonstrating the importance of timely and efficacious care of extremity trauma patients, with particular emphasis on vascular injury assessment. The health care facility settings in which patients present have significant implications in the level of care provided, as availability of diagnostic and therapeutic resources may be limited in some settings. In such circumstances, patients may be transferred to alternate care facilities for higher level of care, with timing of transfer playing a substantial role in successful trauma patient care.

While it is noted that the treatment of severely injured patients in higher level trauma centers allows for access to increased care resources and improved prognostic outcomes, the patient outcomes of trauma patients transferred from lower level to higher level trauma centers may not be as clear. With regards to interhospital patient transfers, there are established statewide trauma policies that guide "re-triage," which is defined as the urgent or emergent transfer of critically ill trauma patients from a non-trauma or lower level trauma facility to an upper level trauma center for higher level of care. The categories for re-triage consideration include perfusion, respiratory status, neurologic status, anatomic findings, and provider judgment. For example, anatomic findings that necessitate transfer to higher level of care facilities include extremity injury with neurovascular compromise. Important components of re-triage include early identification of patients who require higher levels of care as well as established transfer agreements between sending and receiving care facilities. Recognizing that patient transfers may impact overall health outcomes such that transferred extremity trauma patients may have worse clinical outcomes compared to non-transferred patients, the investigators aim to investigate the relationship between transfer status and patient outcomes through conducting a retrospective observational case-control review of extremity trauma patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients aged 18 years or higher with blunt or penetrating extremity trauma injuries

Exclusion criteria

  • Pregnant females with blunt or penetrating extremity trauma injuries
  • Catastrophic head injuries
  • Individuals discharged from the hospital in the first 24 hours of being seen

Treatment and study plan

Packed Red Blood Cell Administration

Other

Difference in occurrence of mortality in patients transferred versus directly admitted who have packed red blood cell administration in the first four hours of arrival to the hospital.

Primary outcomes

  1. Mortality

    Time frame: Measured in the first 30 days of admission

    Incidence of mortality associated with transfer status

  2. Length of total hospital stay

    Time frame: Length of total hospital stay from admission in the hospital is defined as the time frame between admission and discharge. The time frame of collection until the event occurred was 180 days.

    The time spent hospitalized in days.

  3. Operative Cases

    Time frame: Time frame is from admission to discharge and would be collected in the first 180 days.

    The total operative cases required for a patient

  4. Admission lactate levels

    Time frame: he estimated period of time over which preoperative lactate levels are measured occur in the initial 2 hours after admission to the hospital

    Admission lactate levels were defined as the first measured lactate level on admission of an individual who presented as a trauma patient.

Sponsors and collaborators

Lead sponsor

Arrowhead Regional Medical Center

Other

Registry information

Official study title

Time to Hospitalization and Limb Loss in Blunt Extremity Trauma

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 7, 2024
Registry last updated
Jan 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.