Transbrachial Access for Interventions in Patients With Peripheral Arterial Occlusive Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-10

Study Completion Date

2020-10-02

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Complication of Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Control group: compression bandage Study group: compression bandage and positioning splint

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control group

Application of a compression bandage following transbrachial puncture for 24 hours

Group Type OTHER

Transbrachial Access for Interventions

Intervention Type OTHER

Adding a positioning splint in addition to compression bandage after intervention in order to guarantee immobilization of puncture site

Study group

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

Group Type ACTIVE_COMPARATOR

Transbrachial Access for Interventions

Intervention Type OTHER

Adding a positioning splint in addition to compression bandage after intervention in order to guarantee immobilization of puncture site

Interventions

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