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

April 30, 2020 updated by: Lawson Health Research Institute

Reducing Compression Duration Post Trans Radial Cardiac Catheterization

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A5A5
        • London Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 10 minutes
Compression clamp release start after 10 minutes
Other: Compression clamp release
Standard compression clamp is used and will be released at different times according to randomization
Experimental: 20 minutes
Compression clamp release start after 20 minutes
Other: Compression clamp release
Standard compression clamp is used and will be released at different times according to randomization
Active Comparator: 30 minutes
Compression clamp release start after 30 minutes
Other: Compression clamp release
Standard compression clamp is used and will be released at different times according to randomization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hematoma
Time Frame: 1 hour
Hematoma larger than 5 cm
1 hour
Radial artery occlusion
Time Frame: 1 hour
Assessed by Doppler
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding - any
Time Frame: 1 hour
Minor hematoma
1 hour

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison to prior study results
Time Frame: 1 hour
Compared to PRACTICAL study
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Investigators

  • Principal Investigator: Shahar Lavi, MD, London Health Sceinces Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

August 22, 2018

First Submitted That Met QC Criteria

August 22, 2018

First Posted (Actual)

August 24, 2018

Study Record Updates

Last Update Posted (Actual)

May 4, 2020

Last Update Submitted That Met QC Criteria

April 30, 2020

Last Verified

February 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 112619

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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