Registry for Vascular Trauma and Follow-up Examinations

NCT05846321 | Recruiting

• 1 other identifier: Vascular Registry
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Vascular Injury

Keywords

Trauma; Vascular trauma; Bleeding; Ischemia; Registry

Outcome Measures

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

  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 Outcomes (2)

• 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

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated at university hospital Augsburg for trauma

You may qualify if:

• Age over 18 years
• Vascular involvement in trauma
• Isolated vascular injury
• Written informed consent, except for those deceased from trauma sequelae

You may not qualify if:

• Minority
• Lack of consent

Sponsors & Collaborators

• University Hospital Augsburg: lead

Study Sites (1)

University Hospital Augsburg

Augsburg, 86165, Germany

RECRUITING

MeSH Terms

Conditions

Vascular System Injuries; Wounds and Injuries; Hemorrhage; Ischemia

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yvonne Gosslau, MD

CONTACT

+49 821/4002655; yvonne.gosslau@uk-augsburg.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: May 6, 2023
• Study Start: June 1, 2023
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: September 13, 2023

Record last verified: 2023-03

Locations

DE (1)