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Anticoagulant
Combination Strategies for Catheter Complications
N/A
Recruiting
Led By Nishant Sethi, MD
Research Sponsored by Regional Hospital of Scranton
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years
Be older than 18 years old
Must not have
Patients requiring a heparin dose of greater than 50 units per kilogram before, during, or after the procedure for any reason
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to reduce complications after heart procedures done through the wrist by combining different strategies. The goal is to decrease the risk of artery blockage and bleeding while also shortening the time needed for compression
Who is the study for?
This trial is for individuals who have undergone transradial procedures, such as coronary angiography or interventions. Participants should not currently be experiencing complications like bleeding or artery occlusion. The study aims to include those who could benefit from improved hemostasis methods post-procedure.
What is being tested?
The SAFE & FAST Trial is testing whether a combination of lower-dose heparin and two different radial compression devices (Terumo Radial Band and Vaosband) can reduce problems like artery blockage and bleeding after wrist-access heart procedures.
What are the potential side effects?
Potential side effects may include discomfort at the site of compression, bruising, delayed bleeding if the band is removed too early, or rare cases of artery occlusion despite preventive measures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I need more than 50 units/kg of heparin for medical procedures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Hematoma formation
Radial artery occlusion
Rebound bleeding
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group 2-Low dose heparinExperimental Treatment2 Interventions
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 II: Group 1-Regular dose heparinActive Control2 Interventions
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 ®.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Heparin
2003
Completed Phase 4
~22600
Find a Location
Who is running the clinical trial?
Regional Hospital of ScrantonLead Sponsor
1 Previous Clinical Trials
Nishant Sethi, MDPrincipal InvestigatorRegional Hospital of Scranton