Rapid Clamp Release Post Trans-radial Cardiac Catheterization (PRACTICAL-II)

Lawson Health Research Institute

Status: Completed

Conditions: Cardiac Catheterization

Treatments: Other: Compression clamp release

Study type: Interventional

Funder types: Other

Identifiers

NCT03645837

112619

Details and patient eligibility

About

The purpose of the study is to compare different short durations of radial clamp application following an angiogram via a trans-radial approach.

Full description

This is a single-center, prospective, randomized study that will enroll patients that are referred for an angiogram and will compare 3 different durations of radial clamp applications. Patients will be randomly assigned to either 10, 20 or 30-minute clamp applications. The clamps will be gradually released at the end of the assigned durations and participants will be assessed for the radial artery occlusion, hematoma, and other bleeding events.

Enrollment: 450 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnostic catheterization
2. 5 F slender sheath
3. Normal ulno-palmar circulation

Exclusion criteria

1. Abnormal ulno-palmar circulation type D
2. Ad hoc percutaneous coronary intervention
3. Heparin or other anticoagulation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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450 participants in 3 patient groups

10 minutes

Experimental group

Description:

Compression clamp release start after 10 minutes

Treatment:

Other: Compression clamp release

20 minutes

Experimental group

Description:

Compression clamp release start after 20 minutes

Treatment:

Other: Compression clamp release

30 minutes

Active Comparator group

Description:

Compression clamp release start after 30 minutes

Treatment:

Other: Compression clamp release