Registry for Vascular Trauma and Follow-up Examinations

Recruiting

• Conditions: Vascular Injury

• Registration Number: NCT05846321
• Lead Sponsor: University Hospital Augsburg

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-15
• Study First Submitted QC: 2023-04-26
• Study First Posted: 2023-05-06
• Study Start: 2023-06-01
• Last Update Submitted: 2023-09-07
• Last Update Posted: 2023-09-13
• Primary Completion: 2030-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Long term follow-up after vascular injury	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	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

Secondary Outcome Measures

Name	Time	Method
Reintervention rate	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	Treatment of complications as graft occlusion or stenosis
Development of treatment patterns	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	Optional, depending on the amount and quality of data

Trial Locations

Locations (1)

University Hospital Augsburg; 🇩🇪 Augsburg, Germany