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

Primary Purpose

Complication of Treatment

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Transbrachial Access for Interventions
Sponsored by
Wilhelminenspital Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Complication of Treatment focused on measuring transbrachial access, intervention, bleeding, hematoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Vascular and Endovascular Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Control group

Study group

Arm Description

Application of a compression bandage following transbrachial puncture for 24 hours

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Post-interventional pain at puncture site
Evaluation of local pain according to V.A.S. score by asking patients after intervention

Full Information

First Posted
February 4, 2018
Last Updated
May 27, 2023
Sponsor
Wilhelminenspital Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT05892367
Brief Title
Transbrachial Access for Interventions in Patients With Peripheral Arterial Occlusive Disease
Acronym
TBA
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
July 10, 2018 (Actual)
Primary Completion Date
August 21, 2020 (Actual)
Study Completion Date
October 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wilhelminenspital Vienna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complication of Treatment
Keywords
transbrachial access, intervention, bleeding, hematoma

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Control group: compression bandage Study group: compression bandage and positioning splint
Masking
None (Open Label)
Allocation
Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Other
Arm Description
Application of a compression bandage following transbrachial puncture for 24 hours
Arm Title
Study group
Arm Type
Active Comparator
Arm Description
Application of a compression bandage and a positioning splint following transbrachial puncture for 24 hours
Intervention Type
Other
Intervention Name(s)
Transbrachial Access for Interventions
Intervention Description
Adding a positioning splint in addition to compression bandage after intervention in order to guarantee immobilization of puncture site
Primary Outcome Measure Information:
Title
Occurrence of local complications at the puncture site
Description
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
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Post-interventional pain at puncture site
Description
Evaluation of local pain according to V.A.S. score by asking patients after intervention
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Afshin Assadian, Prim. PD Dr.
Organizational Affiliation
Vascular and Endovascular Surgery, Klinik Ottakring
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Vascular and Endovascular Surgery
City
Vienna
ZIP/Postal Code
1160
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Transbrachial Access for Interventions in Patients With Peripheral Arterial Occlusive Disease

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