Registry for Vascular Trauma and Follow-up Examinations

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.

Recruiting

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Key information

Conditions

Vascular Injury Cardiovascular Diseases Hemorrhage Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases Vascular System Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Augsburg

Augsburg, 86165, Germany

Location status: Recruiting

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Long term follow-up after vascular injury

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 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 outcomes

Reintervention rate

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 year

Treatment of complications as graft occlusion or stenosis
Development of treatment patterns

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 year

Optional, depending on the amount and quality of data

Study contacts

Contact information is provided by the study sponsor or research team.

Yvonne Gosslau, MD

CONTACT

[email protected]

+49 821/4002655

Sponsors and collaborators

Lead sponsor

University Hospital Augsburg

Other

Registry information

Important dates

Study start: 2023
Primary completion: 2030
Study completion: 2030
First posted: May 6, 2023
Registry last updated: Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed