Regional Hospital of Scranton
Nishant Sethi
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.
Cardiovascular Diseases
Bleeding
Arterial Puncture
Catheter Complications
Occlusion of Artery
Heparin
Terumo Radial Band
Vaosband
NA
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 Type : | INTERVENTIONAL |
| Estimated Enrollment : | 450 participants |
| Masking : | NONE |
| Primary Purpose : | TREATMENT |
| Official Title : | Safe and Fast Radial Hemostasis Using Synergistic Strategies: SAFE & FAST Trial |
| Actual Study Start Date : | 2024-08-15 |
| Estimated Primary Completion Date : | 2026-08-15 |
| Estimated Study Completion Date : | 2026-08-15 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
Regional Hospital of Scranton
Scranton, Pennsylvania, United States, 18510
RECRUITING
Apex Heart Institute
Ahmedabad, Gujarat, India, 380059