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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05846321
Other study ID # Vascular Registry
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2023
Est. completion date December 31, 2030

Study information

Verified date March 2023
Source University Hospital Augsburg
Contact Yvonne Gosslau, MD
Phone +49 821/4002655
Email yvonne.gosslau@uk-augsburg.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date December 31, 2030
Est. primary completion date December 31, 2030
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany University Hospital Augsburg Augsburg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Augsburg

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Long term follow-up after vascular injury Inclusion 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
Assessments 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 year
Secondary Reintervention rate Treatment of complications as graft occlusion or stenosis Assessments 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 year
Secondary Development of treatment patterns Optional, depending on the amount and quality of data Assessments 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 year
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