Extremity Trauma At a Level 1 Trauma Center

NCT06402669 | Completed

• 1 other identifier: 22-04
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Trauma Injury; Trauma Blunt; Vascular Trauma

Outcome Measures

Primary Outcomes (4)

• Mortality

  Incidence of mortality associated with transfer status

  Measured in the first 30 days of admission

• Length of total hospital stay

  The time spent hospitalized in days.

  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.

• Operative Cases

  The total operative cases required for a patient

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

• Admission lactate levels

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

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

Study Arms (2)

Transferred from Outside Hospital

Patients with blunt or penetrating trauma that are transferred from an outside hospital to admitting level 1 trauma center

Other: Packed Red Blood Cell Administration

Direct Admission to Hospital

Patients with blunt or penetrating trauma that are directly brought to level 1 trauma center

Other: Packed Red Blood Cell Administration

Interventions

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.

Direct Admission to Hospital; Transferred from Outside Hospital

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study was completed at the Arrowhead Regional Medical Center (ARMC) in San Bernardino County, California. The ARMC is a 456-bed acute-care teaching facility and ACS-verified level I trauma center. The ARMC emergency department (ED) is one of the busiest in the state of California with more than 100,000 visits and over 3,000 adult trauma cases annually.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arrowhead Regional Medical Center: lead

Study Sites (1)

Arrowhead Regional Medical Center

Colton, California, 92324, United States

Location

Related Publications (4)

• Devendra A, Nishith P G, Dilip Chand Raja S, Dheenadhayalan J, Rajasekaran S. Current updates in management of extremity injuries in polytrauma. J Clin Orthop Trauma. 2021 Jan;12(1):113-122. doi: 10.1016/j.jcot.2020.09.031. Epub 2020 Sep 24.

  PMID: 33716436 BACKGROUND

• Waalwijk JF, Lokerman RD, van der Sluijs R, Fiddelers AAA, den Hartog D, Leenen LPH, Poeze M, van Heijl M; Pre-hospital Trauma Triage Research Collaborative (PTTRC). The influence of inter-hospital transfers on mortality in severely injured patients. Eur J Trauma Emerg Surg. 2023 Feb;49(1):441-449. doi: 10.1007/s00068-022-02087-7. Epub 2022 Sep 1.

  PMID: 36048180 BACKGROUND

• Garwe T, Cowan LD, Neas B, Cathey T, Danford BC, Greenawalt P. Survival benefit of transfer to tertiary trauma centers for major trauma patients initially presenting to nontertiary trauma centers. Acad Emerg Med. 2010 Nov;17(11):1223-32. doi: 10.1111/j.1553-2712.2010.00918.x.

  PMID: 21175521 BACKGROUND

• Staudenmayer KL, Hsia RY, Mann NC, Spain DA, Newgard CD. Triage of elderly trauma patients: a population-based perspective. J Am Coll Surg. 2013 Oct;217(4):569-76. doi: 10.1016/j.jamcollsurg.2013.06.017.

  PMID: 24054408 BACKGROUND

MeSH Terms

Conditions

Accidental Injuries; Wounds, Nonpenetrating

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Aldin Malkoc

  Arrowhead Regional Medical Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 7, 2024
• Study Start: January 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: January 30, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)