Radial Artery OcclusionRADIAL-HEMONCT07621185
Manual vs Pneumatic Compression to Prevent Radial Artery Occlusion After Transradial Procedures
A study testing Manual Radial Compression and Pneumatic Radial Compression Device in people with Radial Artery Occlusion and Cardiac Catheterization, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
This study evaluates two commonly used methods of achieving hemostasis after transradial cardiac catheterization: manual compression and pneumatic compression with gradual deflation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radial Artery Occlusion, Cardiac Catheterization
- What is being tested?
- Manual Radial Compression and Pneumatic Radial Compression Device
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,168 participants
- Where
- 1 siteSpain
- Study dates
- 2 Nov 2022to 27 Nov 2024
- 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
- Adults aged ≥18 years
- Undergoing diagnostic or interventional cardiac catheterization via transradial access
- Preserved dual hand circulation confirmed by Barbeau test
- Ability to provide informed consent
- Ability to complete 30-day follow-up
Who cannot join
- Refusal to participate
- Inability to complete follow-up
- Abnormal collateral circulation (Barbeau type D)
- Initial failure of radial access
- Contraindication to prolonged radial compression
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Manual Radial Compression Versus Gradual Pneumatic Compression for the Prevention of Radial Artery Occlusion After Transradial Cardiac Catheterization: A Pragmatic Multicenter Study
This study evaluates two commonly used methods of achieving hemostasis after transradial cardiac catheterization: manual compression and pneumatic compression with gradual deflation.
Transradial access is widely used for diagnostic and interventional cardiac procedures due to its safety profile, but radial artery occlusion remains a relevant complication that may limit future vascular access.
Read more
In this pragmatic, prospective, multicenter study conducted in routine clinical practice, adult patients undergoing transradial cardiac catheterization were assigned to receive either manual compression or pneumatic compression using a standardized patent hemostasis protocol. The primary objective is to compare the incidence of radial artery occlusion at 30 days between both strategies.
Secondary outcomes include local vascular complications, patient-reported pain, and total compression time.
Read the detailed description
Transradial access has become the preferred approach for diagnostic and interventional coronary procedures due to its association with reduced bleeding complications, earlier mobilization, and shorter hospital stay compared with transfemoral access. However, radial artery occlusion (RAO) remains a relevant access-site complication that may limit future vascular access or the use of the radial artery as a conduit for coronary artery bypass grafting.
Hemostasis following radial sheath removal is a critical step in preserving arterial patency. Two commonly used strategies include manual compression using sterile gauze and non-circumferential adhesive dressing, and pneumatic compression using dedicated mechanical devices typically applied with gradual deflation protocols. Both approaches aim to achieve effective hemostasis while maintaining antegrade arterial flow, a concept known as patent hemostasis.
This study was designed as a pragmatic, prospective, multicenter interventional study conducted across eight hospitals in Spain, with central coordination from Hospital Clinic of Barcelona. The objective was to compare the effectiveness and safety of manual radial compression versus pneumatic compression with gradual deflation under standardized patent hemostasis protocols in real-world clinical practice.
Consecutive adult patients undergoing diagnostic or interventional cardiac catheterization via transradial access were included. After sheath removal, participants were assigned in a 1:1 predefined alternating sequence to either manual compression or pneumatic compression strategies.
In the manual compression group, hemostasis was achieved using direct pressure with sterile gauze and a non-circumferential adhesive dressing, with progressive adjustment of pressure to maintain arterial patency assessed by plethysmography. In the pneumatic compression group, a dedicated compression device was applied and gradually deflated according to a standardized protocol to achieve patent hemostasis.
The primary outcome was radial artery occlusion at 30 days, defined as absence of distal plethysmographic signal during radial artery compression assessed using the Barbeau test. Secondary outcomes included local vascular complications (such as hematoma, persistent bleeding, or pseudoaneurysm), patient-reported pain assessed using a visual analog scale (VAS), and total compression time.
All participating centers followed a unified protocol, and hemostasis procedures were performed by trained nursing staff. The study was designed to reflect routine clinical practice conditions and to evaluate whether clinical outcomes are primarily influenced by the type of compression strategy or by the standardized implementation of patent hemostasis protocols.
- Conditions
- Radial Artery Occlusion, Cardiac Catheterization
- Being tested
- Manual Radial Compression, Pneumatic Radial Compression Device
- Keywords
- Transradial Access, Patent Hemostasis, Radial Compression, Pneumatic Compression Device, Manual Compression, Interventional Cardiology
- Medical subject headings
- Arterial Occlusive Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Radial CompressionProcedure or surgery
Direct manual compression using sterile gauze and a non-circumferential adhesive dressing applied after radial sheath removal, with progressive pressure adjustment to achieve patent hemostasis.
Pneumatic Radial Compression DeviceDevice
Application of a pneumatic compression device with gradual deflation following a standardized patent hemostasis protocol to maintain arterial flow while achieving hemostasis.
| Study group | Role | What they receive |
|---|---|---|
| Manual Compression | Experimental | Hemostasis achieved by direct manual compression using sterile gauze and a non-circumferential adhesive dressing, with progressive adjustment of pressure to maintain arterial patency. Compression duration was approximately 3-4 hours depending on the procedure. Receives: Procedure: Manual Radial Compression |
| Pneumatic Compression | Experimental | Hemostasis achieved using a pneumatic compression device with gradual deflation following a standardized patent hemostasis protocol, ensuring bleeding control while maintaining arterial flow. The device was progressively deflated until complete removal. Receives: Device: Pneumatic Radial Compression Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radial Artery Occlusion
Radial artery occlusion assessed by absence of distal plethysmographic signal during radial artery compression using the Barbeau test.
Measured: 30 days
Secondary outcomes (3)
Local Vascular Complications
Incidence of access-site complications including hematoma, persistent bleeding, pseudoaneurysm, or other local vascular complications.
Measured: During hospital stay and up to 30 days
Pain During Compression
Patient-reported pain during the compression period assessed using a visual analog scale (VAS).
Measured: Immediately after compression
Total Compression Time
Total duration of radial compression measured in minutes from sheath removal to device or dressing removal.
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start2 Nov 2022
- Primary completion27 Nov 2024
- Study completion27 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radial Artery OcclusionStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants were assigned in a 1:1 predefined alternating sequence to either manual radial compression or pneumatic compression with gradual deflation following sheath removal.
- Masking
- None (open label)
- Enrolment
- 1,168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Montserrat Pardo, RN, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07621185
- Sponsor's protocol ID
- HCB-RAO-HEMOSTASIS-2022
- Other IDs
- HCB/2021/1166
- Acronym
- RADIAL-HEMO
- Status last verified
- Mar 2026
- First submitted
- 27 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manual Radial Compression Versus Gradual Pneumatic Compression for the Prevention of Radial Artery Occlusion After Transradial Cardiac Catheterization: A Pragmatic Multicenter Study
- ClinicalTrials.gov ID
- NCT07621185
- Acronym / sponsor ID
- RADIAL-HEMO / HCB-RAO-HEMOSTASIS-2022
- Conditions
- Radial Artery Occlusion, Cardiac Catheterization
- Keywords
- Transradial Access, Patent Hemostasis, Radial Compression, Pneumatic Compression Device, Manual Compression, Interventional Cardiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,168 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 2 Nov 2022 (actual)
- Primary completion
- 27 Nov 2024 (actual)
- Study completion
- 27 Nov 2024 (actual)
- First posted
- 2 Jun 2026 (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.
This study evaluates two commonly used methods of achieving hemostasis after transradial cardiac catheterization: manual compression and pneumatic compression with gradual deflation.
Transradial access is widely used for diagnostic and interventional cardiac procedures due to its safety profile, but radial artery occlusion remains a relevant complication that may limit future vascular access.
In this pragmatic, prospective, multicenter study conducted in routine clinical practice, adult patients undergoing transradial cardiac catheterization were assigned to receive either manual compression or pneumatic compression using a standardized patent hemostasis protocol. The primary objective is to compare the incidence of radial artery occlusion at 30 days between both strategies.
Secondary outcomes include local vascular complications, patient-reported pain, and total compression time.
Detailed description
Transradial access has become the preferred approach for diagnostic and interventional coronary procedures due to its association with reduced bleeding complications, earlier mobilization, and shorter hospital stay compared with transfemoral access. However, radial artery occlusion (RAO) remains a relevant access-site complication that may limit future vascular access or the use of the radial artery as a conduit for coronary artery bypass grafting.
Hemostasis following radial sheath removal is a critical step in preserving arterial patency. Two commonly used strategies include manual compression using sterile gauze and non-circumferential adhesive dressing, and pneumatic compression using dedicated mechanical devices typically applied with gradual deflation protocols. Both approaches aim to achieve effective hemostasis while maintaining antegrade arterial flow, a concept known as patent hemostasis.
This study was designed as a pragmatic, prospective, multicenter interventional study conducted across eight hospitals in Spain, with central coordination from Hospital Clinic of Barcelona. The objective was to compare the effectiveness and safety of manual radial compression versus pneumatic compression with gradual deflation under standardized patent hemostasis protocols in real-world clinical practice.
Consecutive adult patients undergoing diagnostic or interventional cardiac catheterization via transradial access were included. After sheath removal, participants were assigned in a 1:1 predefined alternating sequence to either manual compression or pneumatic compression strategies.
In the manual compression group, hemostasis was achieved using direct pressure with sterile gauze and a non-circumferential adhesive dressing, with progressive adjustment of pressure to maintain arterial patency assessed by plethysmography. In the pneumatic compression group, a dedicated compression device was applied and gradually deflated according to a standardized protocol to achieve patent hemostasis.
The primary outcome was radial artery occlusion at 30 days, defined as absence of distal plethysmographic signal during radial artery compression assessed using the Barbeau test. Secondary outcomes included local vascular complications (such as hematoma, persistent bleeding, or pseudoaneurysm), patient-reported pain assessed using a visual analog scale (VAS), and total compression time.
All participating centers followed a unified protocol, and hemostasis procedures were performed by trained nursing staff. The study was designed to reflect routine clinical practice conditions and to evaluate whether clinical outcomes are primarily influenced by the type of compression strategy or by the standardized implementation of patent hemostasis protocols.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were assigned in a 1:1 predefined alternating sequence to either manual radial compression or pneumatic compression with gradual deflation following sheath removal.
| Arm | Type | Receives |
|---|---|---|
| Manual Compression | Experimental | Procedure: Manual Radial CompressionHemostasis achieved by direct manual compression using sterile gauze and a non-circumferential adhesive dressing, with progressive adjustment of pressure to maintain arterial patency. Compression duration was approximately 3-4 hours depending on the procedure. |
| Pneumatic Compression | Experimental | Device: Pneumatic Radial Compression DeviceHemostasis achieved using a pneumatic compression device with gradual deflation following a standardized patent hemostasis protocol, ensuring bleeding control while maintaining arterial flow. The device was progressively deflated until complete removal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged ≥18 years
- Undergoing diagnostic or interventional cardiac catheterization via transradial access
- Preserved dual hand circulation confirmed by Barbeau test
- Ability to provide informed consent
- Ability to complete 30-day follow-up
Key exclusion criteria (5 listed)
- Refusal to participate
- Inability to complete follow-up
- Abnormal collateral circulation (Barbeau type D)
- Initial failure of radial access
- Contraindication to prolonged radial compression
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 |
|---|---|---|
| Manual Radial CompressionDirect manual compression using sterile gauze and a non-circumferential adhesive dressing applied after radial sheath removal, with progressive pressure adjustment to achieve patent hemostasis. | Procedure or surgery | Manual Compression |
| Pneumatic Radial Compression DeviceApplication of a pneumatic compression device with gradual deflation following a standardized patent hemostasis protocol to maintain arterial flow while achieving hemostasis. | Device | Pneumatic Compression |
Primary outcome
Radial Artery Occlusion
Time frame: 30 days
Radial artery occlusion assessed by absence of distal plethysmographic signal during radial artery compression using the Barbeau test.
3 secondary outcomes
Local Vascular Complications
Time frame: During hospital stay and up to 30 days
Pain During Compression
Time frame: Immediately after compression
Total Compression Time
Time frame: During procedure
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 2 Jun 2026.
- 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.
Montserrat Pardo, RN principal investigator
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Radial Compression and Pneumatic Radial Compression Device in people with Radial Artery Occlusion and Cardiac Catheterization, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 5 inclusion and 5 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 2 Jun 2026. 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 Spain. 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?
Radial Artery Occlusion (time frame: 30 days). 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 2 Jun 2026.