Heparin Dose for Radial Angiography

July 2, 2012 updated by: Robert Welsh, University of Alberta

Low Versus High Dose Unfractionated Heparin in Patients Undergoing Angiography Via the Radial Artery

At present, coronary angiogram is usually performed either through an artery in your groin or wrist. An important limitation of the wrist approach is an increase rate of blockage of the wrist artery. It is possible that the dose of blood thinner (i.e. heparin) may decrease the risk of blockage. Early studies seem to suggest that higher dose is required to reduce the risk of this important complication. However, to date there has not been a definitive study to determine the most appropriate heparin dose for the prevention of this complication. The main goal of this study is to determine the appropriate heparin dose to prevent wrist artery blockage and to determine risk factors for developing such a complication.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 4

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
    • Alberta
      • Edmonton, Alberta, Canada, T6G2B7
        • Mazankowski Alberta Heart Institute

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:

  • Patients older than 18 years of age who were referred for either urgent or elective cardiac catheterization were eligible for the study if a normal Allen's test was demonstrated

Exclusion Criteria:

  • myocardial infarction with shock,
  • ST-elevation myocardial infarction,
  • patients undergoing planned percutaneous coronary intervention, and
  • patients in whom transradial approach is contraindicated such as hemodialysis patients

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: low dose heparin
30 units per kilogram of unfractionated heparin
Drug: unfractionated heparin
unfractionated heparin
ACTIVE_COMPARATOR: High dose heparin
70 units per kilogram of unfractionated heparin (UFH) intravenously
Drug: unfractionated heparin
unfractionated heparin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
radial artery occlusion
Time Frame: one month
The primary endpoint was radial artery occlusion defined as absence palpable radial artery with no flow as assessed by Doppler study
one month

Collaborators and Investigators

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

Sponsor

University of Alberta

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

July 1, 2008

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

December 1, 2010

Study Registration Dates

First Submitted

June 28, 2012

First Submitted That Met QC Criteria

July 2, 2012

First Posted (ESTIMATE)

July 6, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

July 6, 2012

Last Update Submitted That Met QC Criteria

July 2, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00001925

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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