Cardiovascular DiseasesNCT06549842
Safe and Fast Radial Hemostasis Using Synergistic Strategies: SAFE & FAST Trial
A study testing Heparin, Terumo Radial Band and Vaosband in people with Cardiovascular Diseases and Bleeding, run by Regional Hospital of Scranton at 2 sites in 2 countries.
Trial summary
The Safe and Fast Radial Hemostasis using Synergistic Strategies (SAFE \& FAST) trial is an interventional study aimed at reducing the incidence of radial artery occlusion (RAO) rebound bleeding, and the required compression time after transradial approach (TRA) procedures, which have become the default access for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Bleeding, Arterial Puncture
- What is being tested?
- Heparin, Terumo Radial Band and Vaosband
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 451 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Aug 2024to 20 Feb 2026
- 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
- Patients referred for diagnostic transradial cardiac catheterization
- Age ≥ 18 years
- Ability to provide written informed consent
Who cannot join
- Absence of written informed consent
- Patients on long-term systemic anticoagulation therapy for a different indication
- Patients requiring a heparin dose of greater than 50 units per kilogram before, during, or after the procedure for any reason.
- Patients requiring greater than 6 French catheter access
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Regional Hospital of Scranton
Scranton, Pennsylvania, 18510
About this study
The Safe and Fast Radial Hemostasis using Synergistic Strategies (SAFE \& FAST) trial is an interventional study aimed at reducing the incidence of radial artery occlusion (RAO) rebound bleeding, and the required compression time after transradial approach (TRA) procedures, which have become the default access for coronary procedures globally. The hypothesis is that combining lower-dose heparin and radial hemostasis with simultaneous ipsilateral ulnar artery compression could achieve these improved outcomes.
Read the detailed description
Patients referred for diagnostic trans-radial cardiac catheterization who meet the inclusion criteria will be randomized into two groups. Group 1 will receive a standard heparin dose (50 U/Kg) with a total compression time of 2 hours using the TR band ® . Group 2 will receive a reduced heparin dose (25 U/Kg) and a compression time of 60 minutes using the VASOBand™, with simultaneous ipsilateral ulnar artery compression.
The study's primary endpoint is a composite of rebound bleeding, post-procedural RAO, and hematoma formation. Radial artery patency will be evaluated using ultrasonography.
With an expected complication rate of 8.2% in Group 1 and 4.5% in Group 2, a sample size of 207 patients per group will provide an 80% power to demonstrate non-inferiority for the treatment group at the alpha 2.5% level. The statistical analysis plan will use descriptive statistics for baseline data and 95% confidence intervals for outcome variables. If non-inferiority is demonstrated, there will be a superiority test performed to examine if Group 2 is superior.
In conclusion, the SAFE \& FAST trial intends to establish a safer, quicker protocol for hemostasis after TRA procedures, with the potential to reduce patient recovery time and improve procedure throughput in cardiac catheterization laboratories.
- Conditions
- Cardiovascular Diseases, Bleeding, Arterial Puncture, Catheter Complications, Occlusion of Artery
- Being tested
- Heparin, Terumo Radial Band, Vaosband
- Keywords
- Radial artery occlusion, Rebound Bleeding, Transradial access, Coronary angiography
- Medical subject headings
- Cardiovascular Diseases, Hemorrhage, Arterial Occlusive Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeparinDrug
The intervention for this study is the dose of heparin. Patients randomized to group 1 will receive a heparin dose of 50U/kg and those in group 2 will receive a lower dose of heparin at 25U/kg. Recovery period for group 1 would be 2 hours whereas for group 2 would be 1 hour.
Terumo Radial BandDevice
Also called TR Band, Radial artery compression device
Group 1 will receive TR band post cardiac catheterization for radial hemostasis.
VaosbandDevice
Group 2 will receive Vasoband post cardiac catheterization for radial hemostasis.
| Study group | Role | What they receive |
|---|---|---|
| Group 1-Regular dose heparin | Active comparator | Patients in this arm will be labeled as Group 1. Patients will receive a standard heparin dose (50U/Kg) with a total compression time of 2 hours using the TR band ®. Receives: Drug: Heparin; Device: Terumo Radial Band |
| Group 2-Low dose heparin | Experimental | Patients in this arm will be labeled as Group 2. Patients will receive a reduced heparin dose (25 U/Kg) and a compression time of 60 minutes using the VASOBand™, with simultaneous ipsilateral ulnar artery compression. Receives: Drug: Heparin; Device: Vaosband |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rebound bleeding
Rebound bleeding necessitating the reapplication of the hemostatic compression.
Measured: 24 hours
Radial artery occlusion
Post-procedural predischarge radial artery occlusion is evaluated between 30 minutes and 24 hours after the procedure.
Measured: 24 hours
Hematoma formation
Hematoma formation during or after the procedure as ranked by the EASY criteria.
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 posted12 Aug 2024
- Study start15 Aug 2024
- Primary completion15 Feb 2026
- Study completion20 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 451 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regional Hospital of Scranton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nishant Sethi, Regional Hospital of Scranton
- Investigators
- Nishant Sethi, MD, Principal investigator, Regional Hospital of Scranton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06549842
- Sponsor's protocol ID
- 1378751
- Status last verified
- Feb 2026
- First submitted
- 6 Aug 2024
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safe and Fast Radial Hemostasis Using Synergistic Strategies: SAFE & FAST Trial
- ClinicalTrials.gov ID
- NCT06549842
- Acronym / sponsor ID
- 1378751
- Conditions
- Cardiovascular Diseases, Bleeding, Arterial Puncture, Catheter Complications, Occlusion of Artery
- Keywords
- Radial artery occlusion, Rebound Bleeding, Transradial access, Coronary angiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 451 participants (actual)
- Lead sponsor
- Regional Hospital of ScrantonUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 15 Feb 2026 (actual)
- Study completion
- 20 Feb 2026 (actual)
- First posted
- 12 Aug 2024 (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 Safe and Fast Radial Hemostasis using Synergistic Strategies (SAFE \& FAST) trial is an interventional study aimed at reducing the incidence of radial artery occlusion (RAO) rebound bleeding, and the required compression time after transradial approach (TRA) procedures, which have become the default access for coronary procedures globally. The hypothesis is that combining lower-dose heparin and radial hemostasis with simultaneous ipsilateral ulnar artery compression could achieve these improved outcomes.
Detailed description
Patients referred for diagnostic trans-radial cardiac catheterization who meet the inclusion criteria will be randomized into two groups. Group 1 will receive a standard heparin dose (50 U/Kg) with a total compression time of 2 hours using the TR band ® . Group 2 will receive a reduced heparin dose (25 U/Kg) and a compression time of 60 minutes using the VASOBand™, with simultaneous ipsilateral ulnar artery compression.
The study's primary endpoint is a composite of rebound bleeding, post-procedural RAO, and hematoma formation. Radial artery patency will be evaluated using ultrasonography.
With an expected complication rate of 8.2% in Group 1 and 4.5% in Group 2, a sample size of 207 patients per group will provide an 80% power to demonstrate non-inferiority for the treatment group at the alpha 2.5% level. The statistical analysis plan will use descriptive statistics for baseline data and 95% confidence intervals for outcome variables. If non-inferiority is demonstrated, there will be a superiority test performed to examine if Group 2 is superior.
In conclusion, the SAFE \& FAST trial intends to establish a safer, quicker protocol for hemostasis after TRA procedures, with the potential to reduce patient recovery time and improve procedure throughput in cardiac catheterization laboratories.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Group 1-Regular dose heparin | Active comparator | Drug: Heparin, Device: Terumo Radial BandPatients in this arm will be labeled as Group 1. Patients will receive a standard heparin dose (50U/Kg) with a total compression time of 2 hours using the TR band ®. |
| Group 2-Low dose heparin | Experimental | Drug: Heparin, Device: VaosbandPatients in this arm will be labeled as Group 2. Patients will receive a reduced heparin dose (25 U/Kg) and a compression time of 60 minutes using the VASOBand™, with simultaneous ipsilateral ulnar artery compression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients referred for diagnostic transradial cardiac catheterization
- Age ≥ 18 years
- Ability to provide written informed consent
Key exclusion criteria (4 listed)
- Absence of written informed consent
- Patients on long-term systemic anticoagulation therapy for a different indication
- Patients requiring a heparin dose of greater than 50 units per kilogram before, during, or after the procedure for any reason.
- Patients requiring greater than 6 French catheter access
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 |
|---|---|---|
| HeparinThe intervention for this study is the dose of heparin. Patients randomized to group 1 will receive a heparin dose of 50U/kg and those in group 2 will receive a lower dose of heparin at 25U/kg. Recovery period for group 1 would be 2 hours whereas for group 2 would be 1 hour. | Drug | Group 1-Regular dose heparin, Group 2-Low dose heparin |
| Terumo Radial BandAlso: TR Band, Radial artery compression deviceGroup 1 will receive TR band post cardiac catheterization for radial hemostasis. | Device | Group 1-Regular dose heparin |
| VaosbandGroup 2 will receive Vasoband post cardiac catheterization for radial hemostasis. | Device | Group 2-Low dose heparin |
Primary outcome
Rebound bleeding
Time frame: 24 hours
Rebound bleeding necessitating the reapplication of the hemostatic compression.
Radial artery occlusion
Time frame: 24 hours
Post-procedural predischarge radial artery occlusion is evaluated between 30 minutes and 24 hours after the procedure.
Hematoma formation
Time frame: 24 hours
Hematoma formation during or after the procedure as ranked by the EASY criteria.
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 3 Mar 2026.
- Radial Artery Occlusion After Transradial Interventions: A Systematic Review and Meta-AnalysisLink provided by the sponsor.
- Influence of the ratio between radial artery inner diameter and sheath outer diameter on radial artery flow after transradial coronary interventionLink provided by the sponsor.
- Multicenter Randomized Evaluation of High Versus Standard Heparin Dose on Incident Radial Arterial Occlusion After Transradial Coronary Angiography: The SPIRIT OF ARTEMIS StudyLink provided by the sponsor.
- Radial compression guided by mean artery pressure versus standard compression with a pneumatic device (RACOMAP)Link provided by the sponsor.
- Randomized clinical trial on short-time compression with Kaolin-filled pad: a new strategy to avoid early bleeding and subacute radial artery occlusion after percutaneous coronary interventionLink provided by the sponsor.
- The Leipzig prospective vascular ultrasound registry in radial artery catheterization: impact of sheath size on vascular complicationsLink provided by the sponsor.
- 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.
Nishant Sethi, MD principal investigator
Regional Hospital of Scranton
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heparin, Terumo Radial Band and Vaosband in people with Cardiovascular Diseases and Bleeding, run by Regional Hospital of Scranton at 2 sites in 2 countries.
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 4 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 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, India. 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?
Rebound bleeding (time frame: 24 hours). The study lists 3 primary outcomes in all. 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 3 Mar 2026.