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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04455373
Other study ID # 1025/2018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2002
Est. completion date February 1, 2020

Study information

Verified date June 2020
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Introduction:

Vascular bypass surgery in children differs significantly from adults. It is a rarely performed procedure in the setting of trauma and tumor surgery to facilitate limb salvage. Beside the technical challenges to reconstruct the small and spastic vessels, bypass grafting should not impede growth of the extremity. The primary aim of this study was to assess long-term outcome after pediatric bypass grafting, in a single academic center, focusing on potential effects on limb development.

Methods:

In this retrospective cohort analyses we included all pediatric patients undergoing vascular bypass grafting at the Medical University of Vienna between 2002-2017. All patients ≤ 18 years suffered a traumatic injury or underwent a tumor resection of the lower or upper limb, respectively. The youngest female patient was 0.4 years, the youngest male patient was 3.5 years.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date February 1, 2020
Est. primary completion date January 30, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Months to 18 Years
Eligibility Inclusion Criteria:

- age <18 years

- planned vascular bypass grafting

Exclusion Criteria:

- age >18 years

- no vascular intervention

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
pediatric vascular bypass grafting
pediatric vascular bypass grafting

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Outcome

Type Measure Description Time frame Safety issue
Primary bypass growth bypass growth 10 years
Secondary autologous vs. PTFE graft patients will either receive an autologous bypass graft or PTFE graft patency rate in 1 year
Secondary revision surgery revision surgery <30 days
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