Extremity Trauma At a Level 1 Trauma Center

NCT ID: NCT06402669

Last Updated: 2025-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-01-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Trauma Injury Trauma Blunt Vascular Trauma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Transferred from Outside Hospital

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

Packed Red Blood Cell Administration

Intervention Type 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

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

Packed Red Blood Cell Administration

Intervention Type 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.

Interventions

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Packed Red Blood Cell Administration

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arrowhead Regional Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aldin Malkoc

Role: STUDY_CHAIR

Arrowhead Regional Medical Center

Locations

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Arrowhead Regional Medical Center

Colton, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 33716436 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36048180 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21175521 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24054408 (View on PubMed)

Other Identifiers

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22-04

Identifier Type: -

Identifier Source: org_study_id

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