Transbrachial Access for Interventions in Patients With Peripheral Arterial Occlusive Disease (TBA)

Wilhelminenspital Vienna

Status: Completed

Conditions: Complication of Treatment

Treatments: Other: Transbrachial Access for Interventions

Study type: Interventional

Funder types: Other

Identifiers

NCT05892367

TBA 1.2

Details and patient eligibility

About

The aim of the present study is an evaluation, whether an immobilization of the upper extremity by means of a positioning splint can help to reduce the incidence of local complications after transbrachial puncture for peripheral arterial interventions, or not.

Full description

Increasing numbers of peripheral arterial interventions are performed via transbrachial access leading to a higher number of local complications at the puncture site. Patients are demonstrating complications, such as hematoma, false aneurysm, secondary hemorrhage and arterial stenosis or occlusion.

Due to not standardized post-interventional procedure regarding to immobilization a higher risk for local puncture site complication can occur. Usually, a compression bandage its applied to the brachial puncture site. Within this randomized study, patients randomized to the study group will receive an additional splint for 24 hours to ensure an immobilization of the affected arm.

Following the removal of the compression dressing, and the splint in the study group, a duplex ultrasound its performed in order to detect local alterations and pathologies of the brachial artery.

This examination is repeated for each patient in the course of an outpatient control six weeks post-interventionally. Pathologies are documented and treated if necessary.

Enrollment: 95 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female and male patients suffering from peripheral arterial occlusive disease with indicated interventions via an transbrachial access (puncture of the left or right brachial artery)
• age > 18 years
• approval to participate

Exclusion criteria

• unability or refusal to participate
• dialysis patients/AV-fistula interventions
• usage of closure devices

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

95 participants in 2 patient groups

Control group

Other group

Description:

Application of a compression bandage following transbrachial puncture for 24 hours

Treatment:

Other: Transbrachial Access for Interventions

Study group

Active Comparator group

Description:

Application of a compression bandage and a positioning splint following transbrachial puncture for 24 hours

Treatment:

Other: Transbrachial Access for Interventions