Comparison of Heparin Types; Efficacy and Safety

NCT ID: NCT01343381

Last Updated: 2012-05-15

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2011-09-30

Brief Summary

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Heparin, a blood thinner, is used routinely in Open-heart surgery. Do different brands of this drug have differing clinical effects despite both having exactly the same regulation and marketing specifications?

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Hepalean Heparin

Group Type ACTIVE_COMPARATOR

Hepalean Heparin

Intervention Type DRUG

400 units per kilogram bolus prior to initiation of CPB

PPC Heparin

Group Type ACTIVE_COMPARATOR

PPC Heparin

Intervention Type DRUG

400 unit per kilogram bolus prior to initiation of CPB

Interventions

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Hepalean Heparin

400 units per kilogram bolus prior to initiation of CPB

Intervention Type DRUG

PPC Heparin

400 unit per kilogram bolus prior to initiation of CPB

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* will be undergoing cardiopulmonary bypass for coronary artery disease
* has provided written informed consent

Exclusion Criteria

* Allergy or intolerance to Heparin
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kevin H Teoh, MD

Role: PRINCIPAL_INVESTIGATOR

Hamilton Health Sciences: Hamilton General Site

Locations

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Hamilton Health Sciences: Hamilton General Hospital

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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CANNeCTIN

Identifier Type: -

Identifier Source: org_study_id

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