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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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

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

0 / 2Eligibility criteria met