Registry for Vascular Trauma and Follow-up Examinations

Vascular Injury Clinical Trial

Official title:

Registry for Vascular Trauma and Follow-up Examinations

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05846321
• Other study ID #: Vascular Registry
• Status: Recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Vascular Injury
• Vascular System Injuries

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