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OpenTrials
Completed

NCT Number: NCT03645837

Rapid Clamp Release 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.

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Key information

Conditions

Cardiac Catheterization

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

London Health Sciences Centre

London, Ontario, N6A5A5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnostic catheterization
  • 5 F slender sheath
  • Normal ulno-palmar circulation

Exclusion criteria

  • Abnormal ulno-palmar circulation type D
  • Ad hoc percutaneous coronary intervention
  • Heparin or other anticoagulation

Treatment and study plan

Compression clamp release

Other

Standard compression clamp is used and will be released at different times according to randomization

Primary outcomes

  1. Hematoma

    Time frame: 1 hour

    Hematoma larger than 5 cm

  2. Radial artery occlusion

    Time frame: 1 hour

    Assessed by Doppler

Secondary outcomes

  1. Bleeding - any

    Time frame: 1 hour

    Minor hematoma

Other outcomes

  1. Comparison to prior study results

    Time frame: 1 hour

    Compared to PRACTICAL study

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Registry information

Official study title

Reducing Compression Duration Post Trans Radial Cardiac Catheterization

Acronym: PRACTICAL-II

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 24, 2018
Registry last updated
May 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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