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Prospective Observational Vascular Injury Trial (PROOVIT)

  • Status
    Accepting Candidates
  • Age
    N/A
  • Sexes
    All
  • Healthy Volunteers

Description

The objective of this research is to establish a prospective, multicenter, observational study through the American Association for the Surgery of Trauma (AAST) Multicenter Trials Committee. This study, referred to as PROspective Observational Vascular Injury Trial or PROOVIT, aims to capture key elements of vascular trauma presentation, diagnosis, management, outcomes from leading trauma institutions in the US. Data from patients above the age of 2 years with a diagnosis of injury to a named, large vessels following trauma will be collected from the medical record. The location and type of endovascular therapy for vascular trauma will be tracked including comparison of outcomes to those following open operative repair of similar injury patterns. Finally, data elements will be gathered in a wide range of age groups with vascular trauma including the challenging scenarios of pediatric and geriatric vascular injury. Data and endpoints will be observational and involve no alterations in standard patient care. Institutions and providers will conduct normal diagnosis, management and surveillance procedures without interference of this study.

Details

Protocol number IRB201703047

Eligibility

Inclusion: Patients above the age of 2 years with CT/CTA, duplex, angiographic or clinical/ operative diagnosis of injury to a named, large vessels following trauma, the initial management of which is at the enrolling center (i.e. must arrive from point of injury and not prior medical center or facility).
Exclusion Criteria: Patients under the age of 2 years, those in whom the diagnosis of vascular injury is not made or those in whom the initial management of vascular injury was initiated at a prior medical center facility.

Lead researcher

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  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.