Heparin vs Placebo for Cardiac Catheterization

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

3600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-05

Study Completion Date

2026-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Cardiac Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Low dose heparin

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

Group Type ACTIVE_COMPARATOR

Heparin

Intervention Type DRUG

two doses of heparin

High dose heparin

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

Group Type ACTIVE_COMPARATOR

Heparin

Intervention Type DRUG

two doses of heparin

Placebo

Normal saline 0.9%.

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

placebo

Interventions

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Heparin

two doses of heparin

Intervention Type DRUG

Placebos

placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No