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

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

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.

Study Overview

• Status: Completed
• Conditions: Complication of Treatment
• Intervention / Treatment: Other: Transbrachial Access for Interventions

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1160
    • Department of Vascular and Endovascular Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wilhelminenspital Vienna
• Investigators: Principal Investigator: Afshin Assadian, Prim. PD Dr., Vascular and Endovascular Surgery, Klinik Ottakring

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2018
• Primary Completion (Actual): August 21, 2020
• Study Completion (Actual): October 2, 2020

Study Registration Dates

• First Submitted: February 4, 2018
• First Submitted That Met QC Criteria: May 27, 2023
• First Posted (Actual): June 7, 2023

Study Record Updates

• Last Update Posted (Actual): June 7, 2023
• Last Update Submitted That Met QC Criteria: May 27, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: transbrachial access, intervention, bleeding, hematoma
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases
• Other Study ID Numbers: TBA 1.2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No