Arterial Puncture, Bleeding, Cardiovascular Diseases, Catheter Complications, Occlusion of Artery
Conditions
Keywords
Radial artery occlusion, Rebound Bleeding, Transradial access, Coronary angiography
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.
Interventions
DRUGHeparin
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.
DEVICETerumo Radial Band
Group 1 will receive TR band post cardiac catheterization for radial hemostasis.
DEVICEVaosband
Group 2 will receive Vasoband post cardiac catheterization for radial hemostasis.
Sponsors
Regional Hospital of Scranton
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized Controlled Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Hematoma formation | 24 hours | Hematoma formation during or after the procedure as ranked by the EASY criteria. |
Countries
India, United States
Contacts
PRINCIPAL_INVESTIGATORNishant Sethi, MD
Regional Hospital of Scranton
Outcome results
None listed