Improving safety and speed of hemostasis after heart procedures
Safe and Fast Radial Hemostasis Using Synergistic Strategies: SAFE & FAST Trial
This study is testing whether a new way of using heparin and compression after heart procedures can help patients avoid bleeding problems and recover faster.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 450 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Regional Hospital of Scranton Academic / other |
| Locations | 1 site (Scranton, Pennsylvania) |
| Trial ID | NCT06549842 on ClinicalTrials.gov |
What this trial studies
The SAFE & FAST trial aims to reduce complications such as rebound bleeding and radial artery occlusion after transradial cardiac catheterization. Patients will be randomized into two groups: one receiving a standard heparin dose with longer compression time, and the other receiving a lower heparin dose with shorter compression time and additional ulnar artery compression. The study will evaluate outcomes like bleeding and artery patency using ultrasonography. This approach seeks to enhance patient recovery and efficiency in cardiac procedures.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older referred for diagnostic transradial cardiac catheterization.
Not a fit: Patients on long-term anticoagulation therapy or those requiring higher doses of heparin may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer and faster recovery protocols for patients undergoing cardiac catheterization.
How similar studies have performed: Other studies have explored similar hemostatic strategies, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Scranton, Pennsylvania
- Regional Hospital of Scranton — Scranton, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Nishant Sethi, MD — Regional Hospital of Scranton
- Study coordinator: Khyati Khattar, MD
- Email: khyati.khatter@gmail.com
- Phone: 5702092088
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.