Safe and Fast Radial Hemostasis Using Synergistic Strategies: SAFE & FAST Trial

NCT06549842 | Completed FDA Device

• 1 other identifier: 1378751
• Study Type: interventional
• Target: 451
• Locations: 2 countries
• Sites: 2

Brief 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 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.

Conditions

Bleeding; Arterial Puncture; Occlusion of Artery; Cardiovascular Diseases; Catheter Complications

Keywords

Radial artery occlusion; Rebound Bleeding; Transradial access; Coronary angiography

Outcome Measures

Primary Outcomes (3)

• Rebound bleeding

  Rebound bleeding necessitating the reapplication of the hemostatic compression.

  24 hours

• Radial artery occlusion

  Post-procedural predischarge radial artery occlusion is evaluated between 30 minutes and 24 hours after the procedure.

  24 hours

• Hematoma formation

  Hematoma formation during or after the procedure as ranked by the EASY criteria.

  24 hours

Study Arms (2)

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 ®.

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.

Drug: Heparin; Device: Vaosband

Interventions

Heparin DRUG

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.

Group 1-Regular dose heparin; Group 2-Low dose heparin

Terumo Radial Band DEVICE

Group 1 will receive TR band post cardiac catheterization for radial hemostasis.

Also known as: TR Band, Radial artery compression device

Group 1-Regular dose heparin

Vaosband DEVICE

Group 2 will receive Vasoband post cardiac catheterization for radial hemostasis.

Group 2-Low dose heparin

Eligibility Criteria

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

You may qualify if:

• Patients referred for diagnostic transradial cardiac catheterization
• Age ≥ 18 years
• Ability to provide written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Regional Hospital of Scranton: lead

Study Sites (2)

Regional Hospital of Scranton

Scranton, Pennsylvania, 18510, United States

Location

Apex Heart Institute

Ahmedabad, Gujarat, 380059, India

Location

Related Links

• Radial Artery Occlusion After Transradial Interventions: A Systematic Review and Meta-Analysis
• Multicenter Randomized Evaluation of High Versus Standard Heparin Dose on Incident Radial Arterial Occlusion After Transradial Coronary Angiography: The SPIRIT OF ARTEMIS Study
• Randomized Trial of Compression Duration After Transradial Cardiac Catheterization and Intervention
• 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 intervention
• The Leipzig prospective vascular ultrasound registry in radial artery catheterization: impact of sheath size on vascular complications
• Incidence, predictors, and clinical impact of bleeding after transradial coronary stenting and maximal antiplatelet therapy
• Randomized COmparison of Isolated Radial Artery ComPrEssioN Versus Radial and Ipsilateral Ulnar Artery Compression in Achieving Radial Artery Patency: The OPEN-Radial Trial

MeSH Terms

Conditions

Cardiovascular Diseases; Hemorrhage; Arterial Occlusive Diseases

Interventions

Heparin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Nishant Sethi, MD

  Regional Hospital of Scranton

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interventional Cardiologist

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 12, 2024
• Study Start: August 15, 2024
• Primary Completion: February 15, 2026
• Study Completion: February 20, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1); US (1)