Skip to main content
OpenTrials
Completed

NCT Number: NCT01343381

Comparison of Heparin Types; Efficacy and Safety

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?

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hamilton Health Sciences: Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • Allergy or intolerance to Heparin

Treatment and study plan

Hepalean Heparin

Drug

400 units per kilogram bolus prior to initiation of CPB

PPC Heparin

Drug

400 unit per kilogram bolus prior to initiation of CPB

Primary outcomes

  1. Feasibility to conduct a larger trial

    Time frame: pre-cardiopulmonary bypass initiation; peri-operative period (in minutes) to 24 hours post-operatively

    Will the pilot show that the pilot's design is feasible with respect to timely patient enrolment, blinding of treatment allocation, study drug dosage requirements and the collection and measurement of study outcomes; ACT of > 450 seconds after initial pre-CPB heparin bolus, dosage of additional heparin (if any) to maintain an ACT of greater than 450 seconds, differences (if any) in coagulation profiles, differences if any in chest tube drainage, differences (if any) in post-operative transfusion requiements

Secondary outcomes

  1. ACT after initial dose of heparin

    Time frame: pre-cardiopulmonary bypass initiation; peri-operatively(in seconds)

    A dose of 400 units/kgm will be used

  2. Total Heparin Dose used

    Time frame: pre-cardiopulmonary bypass initiation to termination of cardiopulmonary bypass; peri-operatively(in minutes)

    The total dose of heparin needed to maintain an ACT of 480 seconds throught bypass time.

  3. Coagulation

    Time frame: post-cardiopulmonary inition, at the 45 minute on pump time point; perioperatively to 24 hours post-operatively

    aPTT, TCT, anti-Xa and anti IL IIa activity ant TAT levels after initial heparin dose and after 45 minutes on CPB.

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Official study title

Anticoagulant Effect and Reversal of Hepalean Compared With PPC Heparin in Patients Undergoing Cardiopulmonary Bypass: a Pilot Randomized Trial

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Apr 28, 2011
Registry last updated
May 15, 2012

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.