Clinical trial NCT06549842: Safe and Fast Radial Hemostasis Using Synergistic Strategies: SAFE & FAST Trial
Official title: Safe and Fast Radial Hemostasis Using Synergistic Strategies: SAFE & FAST Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Bleeding
Arterial Puncture
Catheter Complications
Occlusion of Artery
Keywords: Radial artery occlusion
Rebound Bleeding
Transradial access
Coronary angiography
Lead sponsor: Regional Hospital of Scranton
Sponsor class: OTHER
First posted: 2024-08-12
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: The Safe and Fast Radial Hemostasis using Synergistic Strategies (SAFE \&amp; 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rebound bleeding
timeFrame: 24 hours
measure: Radial artery occlusion
timeFrame: 24 hours
measure: Hematoma formation
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Scranton
country: United States
facility: Regional Hospital of Scranton
state: Pennsylvania
Study officials:
affiliation: Regional Hospital of Scranton
name: Nishant Sethi, MD
role: PRINCIPAL_INVESTIGATOR
References: