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NCT03645837 Clinical Trial

Rapid Clamp Release Post Trans-radial Cardiac Catheterization

Cardiac Catheterization Clinical Trial

— PRACTICAL-II  

Official title:
Reducing Compression Duration Post Trans Radial Cardiac Catheterization

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03645837
Other study ID # 112619
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2018
Est. completion date June 1, 2019

Study information
Verified date February 2019
Source Lawson Health Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 450
Est. completion date June 1, 2019
Est. primary completion date June 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Compression clamp release
Standard compression clamp is used and will be released at different times according to randomization

Locations
Country Name City State
Canada London Health Sciences Centre London Ontario

Sponsors (1)
Lead Sponsor Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Lavi S, Cheema A, Yadegari A, Israeli Z, Levi Y, Wall S, Alemayehu M, Parviz Y, Murariu BD, McPherson T, Syed J, Bagur R. Randomized Trial of Compression Duration After Transradial Cardiac Catheterization and Intervention. J Am Heart Assoc. 2017 Feb 3;6(2). pii: e005029. doi: 10.1161/JAHA.116.005029. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Other Comparison to prior study results Compared to PRACTICAL study 1 hour
Primary Hematoma Hematoma larger than 5 cm 1 hour
Primary Radial artery occlusion Assessed by Doppler 1 hour
Secondary Bleeding - any Minor hematoma 1 hour
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