NCT05312489

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 5, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

April 5, 2022

Status Verified

April 1, 2022

Enrollment Period

2 years

First QC Date

February 16, 2022

Last Update Submit

April 3, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    Intraoperative

Secondary Outcomes (4)

  • Type of the injury in the upper extremities compared with the lower extremities

    Preoperative

  • Presentation of the injury in the upper extremities compared with the lower extremities

    Preoperative

  • Presence of injury related complications in the upper extremities compared with the lower extremities

    Preoperative

  • Presence of postoperative complications in the upper extremities compared with the lower extremities

    Postoperative for 10 days

Study Arms (2)

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients fulfilling the previous criteria who are operated at Assiut University Hospital - Department of Vascular and Endovascular Surgery.

You may qualify if:

  • All peripheral arterial injuries of one or more of the extremities.

You may not qualify if:

  • Vascular injuries limited to the venous system only.
  • Vascular injuries limited to thoracic, abdominal, or neck vessels.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 34153492BACKGROUND
  • Feliciano 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.

    PMID: 21817992BACKGROUND
  • Feliciano 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.

    PMID: 23928739BACKGROUND
  • Huber GH, Manna B. Vascular Extremity Trauma. 2023 Apr 19. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK536925/

    PMID: 30725610BACKGROUND

Study Officials

  • Mohamed A Mubarak

    Assiut University

    STUDY DIRECTOR
  • Ashraf G Taha

    Assiut University

    STUDY DIRECTOR
  • Osman M Ahmed

    Assiut University

    STUDY DIRECTOR
  • Abanoub E Mousa

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 16, 2022

First Posted

April 5, 2022

Study Start

June 1, 2022

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

April 5, 2022

Record last verified: 2022-04