Registry for Vascular Trauma and Follow-up Examinations
ConditionVascular Injury
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital Augsburg
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age over 18 years
Vascular involvement in trauma
Isolated vascular injury
Written informed consent, except for those deceased from trauma sequelae
Disqualifiers
Minority
Lack of consent
Trial population
Patients treated at university hospital Augsburg for trauma
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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
Time frame
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 yearSecondary outcomes
1
Reintervention rate
Treatment of complications as graft occlusion or stenosis
Time frame
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 year2
Development of treatment patterns
Optional, depending on the amount and quality of data
Time frame
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 yearSponsors and contacts
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Source ClinicalTrials.gov