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Transbrachial Access for Interventions in Patients With Peripheral Arterial Occlusive Disease

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05892367
Acronym
TBA
Enrollment
95
Registered
2023-06-07
Start date
2018-07-10
Completion date
2020-10-02
Last updated
2023-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complication of Treatment

Keywords

transbrachial access, intervention, bleeding, hematoma

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.

Interventions

OTHERTransbrachial Access for Interventions

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

Sponsors

Wilhelminenspital Vienna
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Occurrence of local complications at the puncture site6 weeksLocal 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

MeasureTime frameDescription
Post-interventional pain at puncture site24 hoursEvaluation of local pain according to V.A.S. score by asking patients after intervention

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026