Complication of TreatmentTBANCT05892367
Transbrachial Access for Interventions in Patients With Peripheral Arterial Occlusive Disease
A study testing Transbrachial Access for Interventions in people with Complication of Treatment, run by Wilhelminenspital Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complication of Treatment
- What is being tested?
- Transbrachial Access for Interventions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteAustria
- Study dates
- 10 Jul 2018to 2 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- unability or refusal to participate
- dialysis patients/AV-fistula interventions
- usage of closure devices
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Complication of Treatment
- Being tested
- Transbrachial Access for Interventions
- Keywords
- transbrachial access, intervention, bleeding, hematoma
- Medical subject headings
- Hemorrhage, Hematoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transbrachial Access for InterventionsOther
Adding a positioning splint in addition to compression bandage after intervention in order to guarantee immobilization of puncture site
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | Application of a compression bandage following transbrachial puncture for 24 hours Receives: Other: Transbrachial Access for Interventions |
| Study group | Active comparator | Application of a compression bandage and a positioning splint following transbrachial puncture for 24 hours Receives: Other: Transbrachial Access for Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks
Secondary outcomes (1)
Post-interventional pain at puncture site
Evaluation of local pain according to V.A.S. score by asking patients after intervention
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start10 Jul 2018
- Primary completion21 Aug 2020
- Study completion2 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication of TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Control group: compression bandage Study group: compression bandage and positioning splint
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wilhelminenspital Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edda Skrinjar, M.D., Wilhelminenspital Vienna
- Investigators
- Afshin Assadian, Prim. PD Dr., Principal investigator, Vascular and Endovascular Surgery, Klinik Ottakring
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05892367
- Sponsor's protocol ID
- TBA 1.2
- Acronym
- TBA
- Status last verified
- May 2023
- First submitted
- 4 Feb 2018
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05892367
- Acronym / sponsor ID
- TBA / TBA 1.2
- Conditions
- Complication of Treatment
- Keywords
- transbrachial access, intervention, bleeding, hematoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Wilhelminenspital ViennaUniversity, hospital or other
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- 21 Aug 2020 (actual)
- Study completion
- 2 Oct 2020 (actual)
- First posted
- 7 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Control group: compression bandage Study group: compression bandage and positioning splint
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: Transbrachial Access for InterventionsApplication of a compression bandage following transbrachial puncture for 24 hours |
| Study group | Active comparator | Other: Transbrachial Access for InterventionsApplication of a compression bandage and a positioning splint following transbrachial puncture for 24 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- unability or refusal to participate
- dialysis patients/AV-fistula interventions
- usage of closure devices
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transbrachial Access for InterventionsAdding a positioning splint in addition to compression bandage after intervention in order to guarantee immobilization of puncture site | Other | Control group, Study group |
Primary outcome
Occurrence of local complications at the puncture site
Time frame: 6 weeks
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
1 secondary outcome
Post-interventional pain at puncture site
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Afshin Assadian, Prim. PD Dr. principal investigator
Vascular and Endovascular Surgery, Klinik Ottakring
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transbrachial Access for Interventions in people with Complication of Treatment, run by Wilhelminenspital Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of local complications at the puncture site (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023; AzTrials last refreshed its copy on 6 Nov 2026.