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Recruiting

NCT Number: NCT04374799

Heparin vs Placebo for Cardiac Catheterization

Patients undergoing cardiac catheterization will be randomized to 3 groups: no anticoagulant, low dose anticoagulant and high dose anticoagulant.

Recruiting

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Key information

Conditions

Cardiac Disease Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hamilton Health Sciences, Hamilton, Ontario, Canada

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About this study

Patients undergoing diagnostic cardiac catheterization via the trans-radial approach will be randomly allocated (1:1:1) to receive either low-dose UFH (25 IU/Kg -maximal dose 3,000 IU), high-dose UFH 50 IU/kg -maximal dose 5,000 IU) or N/S 0.9%. After 30 minutes, patients will undergo a gradual wrist band release. Hematoma and radial artery occlusion will be assessed.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • diagnostic cardiac catheterization; Small size sheath; patency of the ulno-palmar circulation

Exclusion criteria

abnormal ulno-palmar circulation; Prior radial artery thrombosis; Prior surgery close to the access site; Emergent cardiac catheterization; History of HIT or allergy to heparin; Patients requiring anticoagulation

Treatment and study plan

Heparin

Drug

two doses of heparin

Placebos

Drug

placebo

Primary outcomes

  1. radial artery occlusion

    Time frame: 1 hour

    by ultrasound

Secondary outcomes

  1. Hematoma> 5 cm

    Time frame: one hour post procedure

    Hematoma at access site

  2. access site bleeding

    Time frame: 1 hour

    any bleeding

  3. non access site bleeding

    Time frame: 1 day

    bleeding not related to access site, such as gastrointestinal

  4. access site complications

    Time frame: 1 day

    pseudoaneurysm, arteriovenous fistula

  5. wrist band duration

    Time frame: 3 hours

    How long wrist band was on

  6. time to discharge

    Time frame: 1 day

    when patient was able to leave the post procedure care area

Study contacts

Contact information is provided by the study sponsor or research team.

Shahar Lavi, MD

CONTACT

[email protected]

519-6633611

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

A Randomized Trial of Heparin vs Placebo in Patients Undergoing Cardiac Catheterization Via the Trans-radial Approach

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
May 5, 2020
Registry last updated
Feb 20, 2026

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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