- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05224635
The PROspective Observational Vascular Injury Trial (PROOVIT)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Several institutions and groups have contributed important insight into the understanding of vascular injury management. However, many of the studies have been single-institution, poorly powered and retrospective. The lack of evidence-based practice is even more concerning given the devastating consequences associated with mismanaged vascular trauma. In light of the stated challenges associated with single-institution study of this injury pattern, the logical method with which to proceed is a prospective, multicenter, observational trail. To date no such registries exists which would allow the prospective aggregation of larger amounts of data pertaining to all phases of vascular trauma management.
Contemporary experience confirms that the management of vascular injury is more complicated than in the past. A multitude of new or updated diagnostic technologies including computed tomography angiography (CTA), magnetic resonance angiography (MRA), duplex and arteriography now exist and are in various degrees of vogue. A damage control approach to vascular trauma is widely championed and includes options for the use of tourniquets, temporary vascular shunts and fasciotomies. Controversies regarding the definitive management of vascular trauma abound and include the advisability of open versus endovascular treatment, decisions about the type of vascular conduit and the utility of venous injury repair lo list a few. Recommendations for surveillance after vascular trauma may include the use of duplex ultrasound or CTA to confirm long-term patency as well as choices related to the use of long-term anti-thrombotic therapy. Finally, it is not uncommon for an institution to find itself facing many of these decision points in the most challenging of all scenarios, the extremes of age including pediatric vascular injury.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75203
- Methodist Dallas Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
subjects presenting to the emergency room
Chart review will include subjects presenting to the emergency room from the 1st of November 2021 through 1st of July 2024.
|
The Society of Vascular Surgery has established a robust vascular disease registry but this organization's focus is on vascular disease and lacks capture of the data points necessary to discern trauma-specific outcomes.
Recent military experience from the United States and United Kingdom, including the Balad Vascular Registry and the Global War on Terror (GWOT) Vascular Registry have provided a contemporary assessment of wartime vascular injury, but again these studies have been retrospective case series and registry reviews.
Furthermore, applications of lessons learned in wartime vascular injury do not completely translate to management in trauma centers in the United States.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
establish an aggregate database
Time Frame: the 1st of November 2021 through 1st of July 2024
|
establish an aggregate database of information of vascular trauma measured by Injury Severity Score (ISS): (range 0-75)
|
the 1st of November 2021 through 1st of July 2024
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jennifer Burris, M.D., Methodist Health System
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 062.TRA.2021.D
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Vascular Injury
-
Centre Hospitalier Universitaire de NiceCompletedLiver Injury | Pseudoaneurysm | Hepatic InjuryFrance
-
University of Texas Southwestern Medical CenterSouthern Methodist University; The University of Texas at ArlingtonRecruitingBrain Injuries | Traumatic Brain Injury | Brain Injury, VascularUnited States
-
Fondazione Policlinico Universitario Agostino Gemelli...CompletedBrain Injuries | Brain Injuries, Traumatic | Brain Injuries, VascularItaly
-
University of ManitobaRecruitingEndothelial Dysfunction | Mechanical Ventilation Complication | Vascular InjuryCanada
-
Irmandade Santa Casa Misericórdia MaríliaCompletedMyocardial Infarction | Injury of Radial Artery | Complications; Device, Vascular | Injury; Blood Vessel, Femoral, ArteryBrazil
-
Sheba Medical CenterWithdrawnInjury; Blood Vessel, Wrist, Radial ArteryIsrael
-
Liverpool Heart and Chest Hospital NHS Foundation...National Institute for Health Research, United Kingdom; Biolife LLC; The Johnson...TerminatedInjury; Blood Vessel, Wrist, Radial ArteryUnited Kingdom
-
Chonnam National University HospitalUnknownRadiation Exposure | Vascular Access Complication | Radial Artery Injury
-
University of Illinois at ChicagoAmerican Heart AssociationRecruitingPeripheral Arterial Disease | Lower Limb Amputation Below Knee (Injury) | Lower Limb Amputation Above Knee (Injury) | Amputation | Peripheral Vascular Disease | Lower Limb Amputation KneeUnited States
-
University of AarhusErasmus Medical Center; Fonden til Lægevidenskabens FremmeCompletedIschemia Reperfusion Injury | Ischaemia Reperfusion InjuryDenmark
Clinical Trials on Vascular Injury
-
Children's Hospital Medical Center, CincinnatiCompleted
-
University of NottinghamCompleted
-
Ann & Robert H Lurie Children's Hospital of ChicagoCompleted
-
Copenhagen University Hospital, HvidovreUniversity of Copenhagen; University College Copenhagen; Team DenmarkActive, not recruitingACL Injury PreventionDenmark
-
Ain Shams Maternity HospitalUnknown
-
University of AarhusUnknown
-
University of GiessenRecruiting
-
National and Kapodistrian University of AthensCompletedHysteroscopy | Endometrial Injury | Repeated Implantation FailuresGreece
-
Mansoura Integrated Fertility CenterCompletedUnexplained Infertility
-
Karadeniz Technical UniversityCompletedPrimary Infertility