The PROspective Observational Vascular Injury Trial (PROOVIT)

Launched by METHODIST HEALTH SYSTEM · Feb 3, 2022

Keywords

ClinConnect Summary

The PROspective Observational Vascular Injury Trial (PROOVIT) is an observational study that collects information from medical records about adults who have a vascular (blood vessel) injury after trauma. Researchers aim to build a large, shared database to better understand how these injuries happen, how they are treated (including imaging and repair options), and what outcomes patients experience. The main thing they’re measuring is the Injury Severity Score (ISS), a number from 0 to 75 that reflects how serious the injury is.

Who might be eligible? Adults aged 16 and older who had a vascular injury after trauma and were treated at Methodist Dallas Medical Center in Dallas, Texas. The injury must be diagnosed by imaging or clinical/operative assessment. Exclusions include anyone under 16, people without a vascular injury, prisoners, or patients transferred from another hospital. Participation involves no extra tests or procedures beyond routine care; researchers will review medical records from November 1, 2021 through July 1, 2024 to collect data. This study is not a treatment trial; it’s a database-building effort to inform better care in the future. It is sponsored by Methodist Health System, does not plan to share individual participant data, and is currently listed as enrolling by invitation with completion expected around December 30, 2024.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adult trauma patients; defined by the American College of Surgeons as individuals age: ≥16 years
• • CT/CTA, duplex, angiographic or clinical/ operative diagnosis of vascular injury following trauma
• • Initial management at Methodist Dallas Medical Center
• Exclusion Criteria:
• • Age: \< 16 years
• • No diagnosis of vascular injury
• • Prisoner
• • Subject transferred from another medical facility