FAQs - Pediatric Prospective Observation Vascular Injury Trial - Trauma Research Center

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General Information

Inclusion Criteria
- Pediatric trauma patients (age 0-17) with any mechanism of injury and a documented major vascular injury to be included
- Major vascular injury, in general, refers to injury of a named vascular structure
Exclusion Criteria
- Any patient >18
- Patients in custody of the juvenile detention system
- Patients who do not have diagnosed vascular injuries
- Patients who have undergone definitive repair of their vascular injury at another hospital
Are there a maximum number of sites that can be involved?

No
Can adult hospitals who take care of occasional pediatric patients be involved?

Yes
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 define 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 grafts
- 35700-35907 – arterial/vein exploration/revision/repair (reoperation)
- 37184-37218 – endovascular thrombectomy
- 37220-37239 – endovascular revascularization (stent/angioplasty)
- 37565-37785 – ligation artery/vein

IRB & SMART IRB

What are our options?
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.
Where can I find UTHealth Houston IRB information?

https://www.uth.edu/cphs/contact-cphs.htm
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: [email protected]
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

Funding

Trauma Research and Combat Casualty Care Collaborative (TRC4)
https://trc4.org/
Funded by the University of Texas System
7703 Floyd Curl Dr., MC 7995 San Antonio, TX 78229-3900
(210) 567-5701

Publication Information

All of the data is de-identified and the centers are also not identified (using numbers instead of names). The dataset will be able to be requested by participating (>5 patients entered) centers for publication. There will not be an author guarantee, but collaborators on manuscript can be included and all centers and participating PIs will be acknowledged.