Transbrachial Access for Interventions in Patients With Peripheral Arterial Occlusive Disease

Study Overview
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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.

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.

Official Title
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Transbrachial Access for Interventions in Patients With Peripheral Arterial Occlusive Disease: Evaluation of Local Complications With or Without Post-interventional Immobilization of the Upper Extremity

Conditions
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Complication of Treatment

Intervention / Treatment
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* Other: Transbrachial Access for Interventions


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Control group: compression bandage Study group: compression bandage and positioning splint
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control group<br>Application of a compression bandage following transbrachial puncture for 24 hours | Other: Transbrachial Access for Interventions<br>* Adding a positioning splint in addition to compression bandage after intervention in order to guarantee immobilization of puncture site<br>|
| Active Comparator: Study group<br>Application of a compression bandage and a positioning splint following transbrachial puncture for 24 hours | Other: Transbrachial Access for Interventions<br>* Adding a positioning splint in addition to compression bandage after intervention in order to guarantee immobilization of puncture site<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of local complications at the puncture site | Local complications as hematoma, bleeding, pseudoaneurysm, arterial dissection, arterial stenosis, arterial occlusion, AV fistula detected by ultrasound 24 hours after intervention and at time of follow-up six weeks after treatment | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-interventional pain at puncture site | Evaluation of local pain according to V.A.S. score by asking patients after intervention | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transbrachial access, intervention, bleeding, hematoma