Viewing Study NCT06402669



Ignite Creation Date: 2024-05-11 @ 8:31 AM
Last Modification Date: 2024-10-26 @ 3:28 PM
Study NCT ID: NCT06402669
Status: COMPLETED
Last Update Posted: 2024-05-07
First Post: 2024-05-03

Brief Title: Extremity Trauma At a Level 1 Trauma Center
Sponsor: Arrowhead Regional Medical Center
Organization: Arrowhead Regional Medical Center

Study Overview

Official Title: Time to Hospitalization and Limb Loss in Blunt Extremity Trauma
Status: COMPLETED
Status Verified Date: 2024-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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
Detailed Description: 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 In an observational study assessing the influence of interhospital transfers of trauma patients on mortality Waalwijk et al demonstrated that transfer of severely injured under-triaged patients to higher level trauma centers was associated with significantly reduced 24-hour and 30-day mortality rates Similar findings were noted in the Garwe et al retrospective cohort study with results demonstrating a significantly lower 30-day mortality rate in patients who were transferred from non-tertiary to tertiary care centers including Level 1 and Level 2 trauma centers for treatment 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 we aim to investigate the relationship between transfer status and patient outcomes through conducting a retrospective observational case-control review of extremity trauma patients

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None