trials
Pedi-PROOVIT

Pediatric Prospective Observation Vascular Injury Trial

Pediatric major vascular injuries are on the rise, yet remain rare and complex, making consistent care a challenge across individual centers. Our multicenter registry offers a vital opportunity to unify data, share expertise, and elevate outcomes for our most vulnerable trauma patients.

More About Pedi-PROOVIT

  • Objective: to determine incidence, etiology, management, and long-term outcomes of pediatric major vascular injury (MVI). We will aim to do this by developing a pediatric multicenter database. There are several secondary objectives which revolve around using the data to generate hypotheses for future study and ultimately develop evidence-based practice strategies for pediatric patients with MVI.

  • Design: This is a prospective multicenter observational study that will be conducted at the hospitals within the University of Texas System. Pediatric Trauma Association member hospitals will also enroll, and our goal is to have as many centers as possible participating.

  • Measure: Data will be collected through prospective chart review. The data collection sheet divides pediatric MVI by anatomic location and there will be no prescriptive changes to the patients’ care. No PHI will be recorded and no specimens will be obtained. This study is approved under a waiver of consent (we are not collecting any identifiers) at the single lead IRB at UTHealth Houston, so there is no consent form or other patient-facing documents.

Participating Centers

BayCare Health System
NYC Health & Hospitals Jacobi Medical Center 
New York Presbyterian Morgan Stanley Children’s Hospital
Boston Children’s Hospital
Dartmouth Hitchcock Medical Center
Children’s Hospital of Philadelphia
Carilion Clinic
West Virginia Children’s Hospital
Nationwide Children’s Hospital
Cincinnati Children’s Hospital Medical Center
Orlando Health Arnold Palmer Hospital for Children
Joe DiMaggio Children’s Hospital
Children’s Healthcare Atlanta
SSM Health Cardinal Glennon 
Le Bonheur Children’s Hospital 
Manning Family Children’s 
UTHealth Houston
University of Texas at Austin
Phoenix Children’s 
Renown Regional Medical Center 
Loma Linda University Medical Center 

Frequently Asked Questions

Have a different question? Contact us below!

Contact Us
What is the inclusion criteria for this study?

1. Pediatric trauma patients (age 0-17) with any mechanism of injury and a documented major vascular injury to be included
2. Major vascular injury, in general, refers to injury of a named vascular structure

What is the exclusion criteria for this study?

1. Any patient over 18
2. Patients in custody of the juvenile detention system
3. Patients who do not have diagnosed vascular injuries
4. Patients who have undergone definitive repair of their vascular injury at another hospital

How will in-hospital morbidity and mortality be released?

UTHealth Houston will only release aggregate data for presentation/publication with numbers larger than 5 to ensure confidentiality.

Do you have a list of codes used to defined the patient population, i.e., a vascular injury?

ICD 9 codes – 900-904
ICD 10 codes – S15, S25, S35, S45, S55, S65, S75, S85, S95 and all their subheadings
CPT Codes
34001-34490 – embolectomy thrombectomy artery/vein
34501-34530 – venous reconstruction
34701-34834 – endovascular procedure aorta/iliac
35201-35286 – arterial/vein open repair
35500-35683 – bypass grafts35700-35907 – arterial/vein exploration/revision/repair (reoperation)
37184-37218 – endovascular thrombectomy
37220-37239 – endovascular revascularization (stent/angioplasty)
37565-37785 – ligation artery/vein

What are our options for IRB?

1. Your IRB can rely on our IRB either through SMART IRB or outside of SMART IRB using reliance forms.
2. Your IRB can take full responsibility (no reliance) and you just submit the study as your normally would as part of a multicenter study. Once it is approved, you would just send us your IRB approval letter.

Do you have contact information for UTHealth Houston IRB?

Name: Committee for the Protection of Human Subjects
Protocol or reference number: UTHealth Houston IRB #: HSC-MS-23-0789
IRB contact Name: Vanessa Fuller, IRB Manager (Panel 3, 4)
IRB Contact Phone Number: (713) 500-7971
IRB contact email address: Susan.V.Fuller@uth.tmc.edu

How can I find our institution's contact for SMART IRB?

1. Go to SMART IRB website: https://smartirb.org/participating-institutions/
2. Search by your institution
3. Contact person will be listed next to your institution’s name

Want to Get Involved?

Click below to see the steps to start contributing data

Get Involved
WE ARE FUNDED BY

Trauma Research and Combat Casualty Care Collaborative