Vascular TraumaNCT05312489
Outcomes of Traumatic Arterial Injuries in Upper vs. Lower Extremities
An observational study of Vascular Trauma, run by Assiut University.
Trial summary
The purpose of this study is to identify and compare the causes of vascular trauma at the extremities, injury characteristics, types of vascular surgical interventions, and the outcomes of traumatic vascular injuries between the upper and lower extremities. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Vascular Trauma
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2022to 1 Jun 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients fulfilling the previous criteria who are operated at Assiut University Hospital - Department of Vascular and Endovascular Surgery.
Who may be able to join
- All peripheral arterial injuries of one or more of the extremities.
Who cannot join
- Vascular injuries limited to the venous system only.
- Vascular injuries limited to thoracic, abdominal, or neck vessels.
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of this study is to identify and compare the causes of vascular trauma at the extremities, injury characteristics, types of vascular surgical interventions, and the outcomes of traumatic vascular injuries between the upper and lower extremities.
Read the detailed description
- Primary patient assessment Patients will be clinically assessed on presentation, and resuscitation protocols will be initiated if signs of hypovolemic shock are present according to Advanced Trauma Life Support guidelines.
- History and physical examination are the most important components of the diagnostic protocol The presence of hard signs of arterial injury
- Absent or diminished pulses
- Active haemorrhage
- Large, expanding, or pulsatile hematoma
- Bruit or thrill
- Distal ischemia is considered an indication for surgery, and no further specific investigative measures will be taken. Soft signs of vascular trauma should be noted as well including
- Small, stable hematoma
- Unexplained hypotension
- History of haemorrhage that is no longer present
- Proximity of injury to major vessels
- Investigations including:
- The use of a hand-held Doppler examination as a diagnostic aid
- Duplex US and CTA for imaging.
- Lab investigations: Complete blood picture, Coagulation profile and Kidney function tests.
Options of intervention:
All vascular trauma patients will be admitted for operative management and follow up. The specific surgical intervention will be determined by the vascular surgeon according to type, site, and extent of the injury, ranging from ligation of the injured vessel to vascular graft interposition.
An injury to a peripheral artery that does not result in complete transection can be repaired depending on luminal diameter with an interrupted or continuous suturing technique. A complete transection of a peripheral artery is first managed with minimal debridement back to healthy intima at both ends then an end-to-end anastomosis or with an interposition graft of autogenous vein or prosthetics arterial graft.
- Conditions
- Vascular Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Upper extremity arterial trauma | Vascular traumatic injuries of the arterial system of the upper limbs. | |
| Lower extremity arterial trauma | Vascular traumatic injuries of the arterial system of the lower limbs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of distal pulse or signals by doppler ultrasound
Presence of distal pulse or signals by doppler ultrasound which indicates technical success of the surgery and patency of the affected artery
Measured: Intraoperative
Secondary outcomes (4)
Type of the injury in the upper extremities compared with the lower extremities
blunt or penetrating injury by history and clinical examination
Measured: Preoperative
Presentation of the injury in the upper extremities compared with the lower extremities
Bleeding or ischemia by clinical examination.
Measured: Preoperative
Presence of injury related complications in the upper extremities compared with the lower extremities
Presence of complications(or not) like compartment syndrome, hematoma or/and associated nerve deficit by clinical examination.
Measured: Preoperative
Presence of postoperative complications in the upper extremities compared with the lower extremities
Presence of complications(or not) like thrombosis of the repaired vessel, pseudoaneurysm formation or/and deep vein thrombosis by clinical examination and Duplex ultrasound evaluation.
Presence of complications(or not) like surgical site infection or/and wound dehiscence by clinical examination and culture and sensitivity.
Measured: Postoperative for 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start1 Jun 2022 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
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 Vascular TraumaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abanoub Emad Mousa Daniel, Assiut University
- Investigators
- Mohamed A Mubarak, Study director, Assiut UniversityAshraf G Taha, Study director, Assiut UniversityOsman M Ahmed, Study director, Assiut UniversityAbanoub E Mousa, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05312489
- Sponsor's protocol ID
- Vascular Trauma
- Status last verified
- Apr 2022
- First submitted
- 16 Feb 2022
- Last updated
- 5 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gallo LK, Ramos CR, Rajani RR, Benarroch-Gampel J. Management and Outcomes after Upper Versus Lower Extremity Vascular Trauma. Ann Vasc Surg. 2021 Oct;76:152-158. doi: 10.1016/j.avsg.2021.05.007. Epub 2021 Jun 18.
PubMed 34153492Feliciano DV, Moore FA, Moore EE, West MA, Davis JW, Cocanour CS, Kozar RA, McIntyre RC Jr. Evaluation and management of peripheral vascular injury. Part 1. Western Trauma Association/critical decisions in trauma. J Trauma. 2011 Jun;70(6):1551-6. doi: 10.1097/TA.0b013e31821b5bdd. No abstract available.
PubMed 21817992Feliciano DV, Moore EE, West MA, Moore FA, Davis JW, Cocanour CS, Scalea TM, McIntyre RC Jr. Western Trauma Association critical decisions in trauma: evaluation and management of peripheral vascular injury, part II. J Trauma Acute Care Surg. 2013 Sep;75(3):391-7. doi: 10.1097/TA.0b013e3182994b48.
PubMed 23928739Huber GH, Manna B. Vascular Extremity Trauma. 2023 Apr 19. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK536925/
PubMed 30725610
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Traumatic Arterial Injuries in Upper vs. Lower Extremities
- ClinicalTrials.gov ID
- NCT05312489
- Acronym / sponsor ID
- Vascular Trauma
- Conditions
- Vascular Trauma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 5 Apr 2022 (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.
The purpose of this study is to identify and compare the causes of vascular trauma at the extremities, injury characteristics, types of vascular surgical interventions, and the outcomes of traumatic vascular injuries between the upper and lower extremities.
Detailed description
- Primary patient assessment Patients will be clinically assessed on presentation, and resuscitation protocols will be initiated if signs of hypovolemic shock are present according to Advanced Trauma Life Support guidelines.
- History and physical examination are the most important components of the diagnostic protocol The presence of hard signs of arterial injury
- Absent or diminished pulses
- Active haemorrhage
- Large, expanding, or pulsatile hematoma
- Bruit or thrill
- Distal ischemia is considered an indication for surgery, and no further specific investigative measures will be taken. Soft signs of vascular trauma should be noted as well including
- Small, stable hematoma
- Unexplained hypotension
- History of haemorrhage that is no longer present
- Proximity of injury to major vessels
- Investigations including:
- The use of a hand-held Doppler examination as a diagnostic aid
- Duplex US and CTA for imaging.
- Lab investigations: Complete blood picture, Coagulation profile and Kidney function tests.
Options of intervention:
All vascular trauma patients will be admitted for operative management and follow up. The specific surgical intervention will be determined by the vascular surgeon according to type, site, and extent of the injury, ranging from ligation of the injured vessel to vascular graft interposition.
An injury to a peripheral artery that does not result in complete transection can be repaired depending on luminal diameter with an interrupted or continuous suturing technique. A complete transection of a peripheral artery is first managed with minimal debridement back to healthy intima at both ends then an end-to-end anastomosis or with an interposition graft of autogenous vein or prosthetics arterial graft.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Upper extremity arterial trauma | – | –Vascular traumatic injuries of the arterial system of the upper limbs. |
| Lower extremity arterial trauma | – | –Vascular traumatic injuries of the arterial system of the lower limbs. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients fulfilling the previous criteria who are operated at Assiut University Hospital - Department of Vascular and Endovascular Surgery.
Key inclusion criteria (1 listed)
- All peripheral arterial injuries of one or more of the extremities.
Key exclusion criteria (2 listed)
- Vascular injuries limited to the venous system only.
- Vascular injuries limited to thoracic, abdominal, or neck vessels.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of distal pulse or signals by doppler ultrasound
Time frame: Intraoperative
Presence of distal pulse or signals by doppler ultrasound which indicates technical success of the surgery and patency of the affected artery
4 secondary outcomes
Type of the injury in the upper extremities compared with the lower extremities
Time frame: Preoperative
Presentation of the injury in the upper extremities compared with the lower extremities
Time frame: Preoperative
Presence of injury related complications in the upper extremities compared with the lower extremities
Time frame: Preoperative
Presence of postoperative complications in the upper extremities compared with the lower extremities
Time frame: Postoperative for 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Background: PubMed 34153492Gallo LK, Ramos CR, Rajani RR, Benarroch-Gampel J. Management and Outcomes after Upper Versus Lower Extremity Vascular Trauma. Ann Vasc Surg. 2021 Oct;76:152-158. doi: 10.1016/j.avsg.2021.05.007. Epub 2021 Jun 18.
- Background: PubMed 21817992Feliciano DV, Moore FA, Moore EE, West MA, Davis JW, Cocanour CS, Kozar RA, McIntyre RC Jr. Evaluation and management of peripheral vascular injury. Part 1. Western Trauma Association/critical decisions in trauma. J Trauma. 2011 Jun;70(6):1551-6. doi: 10.1097/TA.0b013e31821b5bdd. No abstract available.
- Background: PubMed 23928739Feliciano DV, Moore EE, West MA, Moore FA, Davis JW, Cocanour CS, Scalea TM, McIntyre RC Jr. Western Trauma Association critical decisions in trauma: evaluation and management of peripheral vascular injury, part II. J Trauma Acute Care Surg. 2013 Sep;75(3):391-7. doi: 10.1097/TA.0b013e3182994b48.
- Background: PubMed 30725610Huber GH, Manna B. Vascular Extremity Trauma. 2023 Apr 19. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK536925/
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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.
Mohamed A Mubarak study director
Assiut University
Ashraf G Taha study director
Assiut University
Osman M Ahmed study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Trauma, run by Assiut University.
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 2 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: status not confirmed, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abanoub E Mousa (+20882056361, abanob.12167701@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of distal pulse or signals by doppler ultrasound (time frame: Intraoperative). 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 NCT05312489, 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 5 Apr 2022.