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Safe and Fast Radial Hemostasis Using Synergistic Strategies: SAFE & FAST Trial

NCT06549842 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 451

Last updated 2026-03-03

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Heparin

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.

DEVICE

Terumo Radial Band

Group 1 will receive TR band post cardiac catheterization for radial hemostasis.

DEVICE

Vaosband

Group 2 will receive Vasoband post cardiac catheterization for radial hemostasis.

Sponsors & Collaborators

  • Regional Hospital of Scranton

    lead OTHER

Principal Investigators

  • Nishant Sethi, MD · Regional Hospital of Scranton

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-15
Primary Completion
2026-02-15
Completion
2026-02-20
FDA Device
Yes

Countries

  • United States
  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06549842 on ClinicalTrials.gov