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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-15

Study Completion Date

2026-08-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cardiovascular Diseases Bleeding Arterial Puncture Catheter Complications Occlusion of Artery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1-Regular dose heparin

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 ®.

Group Type ACTIVE_COMPARATOR

Heparin

Intervention Type DRUG

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.

Terumo Radial Band

Intervention Type DEVICE

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

Group 2-Low dose heparin

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 Type EXPERIMENTAL

Heparin

Intervention Type DRUG

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.

Vaosband

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DRUG

Terumo Radial Band

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

Intervention Type DEVICE

Vaosband

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

Intervention Type DEVICE

Other Intervention Names

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TR Band Radial artery compression device

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No