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Registry for Vascular Trauma and Follow-up Examinations

Registry for Vascular Trauma and Follow-up Examinations

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05846321
Enrollment
300
Registered
2023-05-06
Start date
2023-06-01
Completion date
2030-12-31
Last updated
2023-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vascular Injury

Keywords

Trauma, Vascular trauma, Bleeding, Ischemia, Registry

Brief summary

Within the framework of the project presented here, a registry for traumatic vascular injuries will be established at Augsburg University Hospital. Patients who are treated at our hospital for an isolated vascular trauma or a vascular involvement in (poly-)trauma will be included. This is a rare complication of trauma, so data collection in a registry is useful to pool data on therapeutic procedures and outcome. These patients differ from the usual vascular surgery patient clientele because there is usually no previous vascular disease. Healthy vessels show different physiological responses than pre-diseased vessels. The usual therapeutic procedures and materials are also developed for arteriosclerotic or aneurysmatic vessels. Therefore, a core objective of this study is to assess long-term outcomes after vascular trauma.

Interventions

None listed

Sponsors

University Hospital Augsburg
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Age over 18 years * Vascular involvement in trauma * Isolated vascular injury * Written informed consent, except for those deceased from trauma sequelae

Exclusion criteria

* Minority * Lack of consent

Design outcomes

Primary

MeasureTime frameDescription
Long term follow-up after vascular injuryAssessments will be performed at different time points. In the first year after trauma at 3 time points: 3, 6 and 12 months. Through study completion, an average of 1 yearInclusion of patients in the vascular trauma registry, then regular follow-up examinations. Conditions resulting from the trauma are to be assessed and recorded. Therefore several examinations should be performed. The kind of examination is due to trauma localization an treatment. Most examinations are non invasive as ultrasound, ABI-measurement and clinical evaluation. Ultrasound documents the patency of vessels/grafts (primary outcome measure). ABI-measurement ist documented as Index (primary outcome measure) Some patients require CT- or MRI-Scans for example in the follow-up of aortic stentgrafts, they document graft patency, vessel diameter in centimeters and endoleak formation (primary outcome measure). The abovementioned examinations combined document the graft/vessel patency as primary outcome measure

Secondary

MeasureTime frameDescription
Reintervention rateAssessments will be performed at different time points. In the first year after trauma at 3 time points: 3, 6 and 12 months. Through study completion, an average of 1 yearTreatment of complications as graft occlusion or stenosis
Development of treatment patternsAssessments will be performed at different time points. In the first year after trauma at 3 time points: 3, 6 and 12 months. Through study completion, an average of 1 yearOptional, depending on the amount and quality of data

Countries

Germany

Contacts

Primary ContactYvonne Gosslau, MD
yvonne.gosslau@uk-augsburg.de+49 821/4002655

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026