Heparin vs Placebo for Cardiac Catheterization

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

Status and phase: Enrolling; Phase 3

Conditions: Cardiac Disease

Treatments: Drug: Placebos; Drug: Heparin

Study type: Interventional

Funder types: Other

Identifiers

NCT04374799

2102

Details and patient eligibility

About

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

Full description

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.

Enrollment: 3,600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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3,600 participants in 3 patient groups, including a placebo group

Low dose heparin

Active Comparator group

Description:

heparin (25 IU/Kg -maximal dose 3,000 IU)

Treatment:

Drug: Heparin

High dose heparin

Active Comparator group

Description:

heparin 50 IU/kg -maximal dose 5,000 IU

Treatment:

Drug: Heparin

Placebo

Placebo Comparator group

Description:

Normal saline 0.9%.

Treatment:

Drug: Placebos