Trauma InjuryNCT06402669
Extremity Trauma At a Level 1 Trauma Center
An observational study of Trauma Injury and Trauma Blunt, run by Arrowhead Regional Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Trauma Injury, Trauma Blunt, Vascular Trauma
- What is being tested?
- Packed Red Blood Cell Administration
- How many people
- 20,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2022to 1 Jan 2024
- Phase
- Observational
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- All patients aged 18 years or higher with blunt or penetrating extremity trauma injuries
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Arrowhead Regional Medical Center
Colton, California, 92324
About this study
Official title: Time to Hospitalization and Limb Loss in Blunt Extremity Trauma
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.
Read the 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. 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
- Trauma Injury, Trauma Blunt, Vascular Trauma
- Being tested
- Packed Red Blood Cell Administration
- Medical subject headings
- Accidental Injuries, Wounds, Nonpenetrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Packed Red Blood Cell AdministrationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Transferred from Outside Hospital | Patients with blunt or penetrating trauma that are transferred from an outside hospital to admitting level 1 trauma center Receives: 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 Receives: Other: Packed Red Blood Cell Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Incidence of mortality associated with transfer status
Measured: Measured in the first 30 days of admission
Length of total hospital stay
The time spent hospitalized in days.
Measured: 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
Measured: 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.
Measured: he estimated period of time over which preoperative lactate levels are measured occur in the initial 2 hours after admission to the hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start1 Jan 2022
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Trauma InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arrowhead Regional Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aldin Malkoc, Study chair, Arrowhead Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402669
- Sponsor's protocol ID
- 22-04
- Status last verified
- May 2024
- First submitted
- 3 May 2024
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33716436Waalwijk 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.
PubMed 36048180Garwe 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.
PubMed 21175521Staudenmayer 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.
PubMed 24054408
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time to Hospitalization and Limb Loss in Blunt Extremity Trauma
- ClinicalTrials.gov ID
- NCT06402669
- Acronym / sponsor ID
- 22-04
- Conditions
- Trauma Injury, Trauma Blunt, Vascular Trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20,000 participants (actual)
- Lead sponsor
- Arrowhead Regional Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 7 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transferred from Outside Hospital | – | Other: Packed Red Blood Cell AdministrationPatients with blunt or penetrating trauma that are transferred from an outside hospital to admitting level 1 trauma center |
| Direct Admission to Hospital | – | Other: Packed Red Blood Cell AdministrationPatients with blunt or penetrating trauma that are directly brought to level 1 trauma center |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All patients aged 18 years or higher with blunt or penetrating extremity trauma injuries
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Packed Red Blood Cell AdministrationDifference 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. | Other | Direct Admission to Hospital, Transferred from Outside Hospital |
Primary outcome
Mortality
Time frame: Measured in the first 30 days of admission
Incidence of mortality associated with transfer status
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.
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Background: PubMed 33716436Devendra 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.
- Background: PubMed 36048180Waalwijk 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.
- Background: PubMed 21175521Garwe 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.
- Background: PubMed 24054408Staudenmayer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aldin Malkoc study chair
Arrowhead Regional Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma Injury and Trauma Blunt, run by Arrowhead Regional Medical Center 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 30 Jan 2025. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mortality (time frame: Measured in the first 30 days of admission). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06402669, which also lists 4 linked publications.
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 30 Jan 2025.