NCT06549842

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 451 (actual)
• Sponsor: Regional Hospital of Scranton · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	Heparin	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.
DEVICE	Terumo Radial Band	Group 1 will receive TR band post cardiac catheterization for radial hemostasis.
DEVICE	Vaosband	Group 2 will receive Vasoband post cardiac catheterization for radial hemostasis.

Timeline

• Start date: 2024-08-15
• Primary completion: 2026-02-15
• Completion: 2026-02-20
• First posted: 2024-08-12
• Last updated: 2026-03-03

Locations

2 sites across 2 countries: United States, India

Regulatory

• FDA-regulated device study