Transbrachial Access for Interventions in Patients With Peripheral Arterial Occlusive Disease

NCT05892367 | Completed DMC

• 1 other identifier: TBA 1.2
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

Complication of Treatment

Keywords

transbrachial access, intervention, bleeding, hematoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Post-interventional pain at puncture site

  24 hours

Study Arms (2)

Control group

OTHER

Application of a compression bandage following transbrachial puncture for 24 hours

Other: Transbrachial Access for Interventions

Study group

ACTIVE COMPARATOR

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

Other: Transbrachial Access for Interventions

Interventions

Transbrachial Access for Interventions OTHER

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

Control group; Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• unability or refusal to participate
• dialysis patients/AV-fistula interventions
• usage of closure devices

Sponsors & Collaborators

• Wilhelminenspital Vienna: lead

Study Sites (1)

Department of Vascular and Endovascular Surgery

Vienna, 1160, Austria

Location

MeSH Terms

Conditions

Hemorrhage; Hematoma

Interventions

Methods

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Afshin Assadian, Prim. PD Dr.

  Vascular and Endovascular Surgery, Klinik Ottakring

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

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

Study Record Dates

• First Submitted: February 4, 2018
• First Posted: June 7, 2023
• Study Start: July 10, 2018
• Primary Completion: August 21, 2020
• Study Completion: October 2, 2020
• Last Updated: June 7, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)