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

Not Applicable

Recruiting

• Conditions: Cardiovascular Diseases; Arterial Puncture; Catheter Complications; Occlusion of Artery; Bleeding
• Interventions: Drug: Heparin; Device: Vaosband; Device: Terumo Radial Band

• Registration Number: NCT06549842
• Lead Sponsor: Regional Hospital of Scranton

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.

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 Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-06
• Study First Submitted QC: 2024-08-08
• Study First Posted: 2024-08-12
• Study Start: 2024-08-15
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-28
• Primary Completion: 2026-08-15
• Study Completion: 2026-08-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

1. Patients referred for diagnostic transradial cardiac catheterization
2. Age ≥ 18 years
3. Ability to provide written informed consent

Exclusion Criteria

1. Absence of written informed consent
2. Patients on long-term systemic anticoagulation therapy for a different indication
3. Patients requiring a heparin dose of greater than 50 units per kilogram before, during, or after the procedure for any reason.
4. Patients requiring greater than 6 French catheter access

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2-Low dose heparin	Heparin	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.
Group 2-Low dose heparin	Vaosband	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.
Group 1-Regular dose heparin	Terumo Radial Band	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 ®.
Group 1-Regular dose heparin	Heparin	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 ®.

Primary Outcome Measures

Name	Time	Method
Hematoma formation	24 hours	Hematoma formation during or after the procedure as ranked by the EASY criteria.
Rebound bleeding	24 hours	Rebound bleeding necessitating the reapplication of the hemostatic compression.
Radial artery occlusion	24 hours	Post-procedural predischarge radial artery occlusion is evaluated between 30 minutes and 24 hours after the procedure.

Trial Locations

Locations (1)

Regional Hospital of Scranton; 🇺🇸 Scranton, Pennsylvania, United States