Comparison of Heparin Types; Efficacy and Safety

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01343381

Enrollment

Registered

2011-04-28

Start date

2011-06-30

Completion date

2011-09-30

Last updated

2012-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Heparin, Coronary artery bypass graft surgery, Anti-coagulation efficacy

Brief summary

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?

Interventions

DRUGHepalean Heparin

400 units per kilogram bolus prior to initiation of CPB

DRUGPPC Heparin

400 unit per kilogram bolus prior to initiation of CPB

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Allergy or intolerance to Heparin

Design outcomes

Primary

Measure	Time frame	Description
Feasibility to conduct a larger trial	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

Measure	Time frame	Description
ACT after initial dose of heparin	pre-cardiopulmonary bypass initiation; peri-operatively(in seconds)	A dose of 400 units/kgm will be used
Total Heparin Dose used	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.
Coagulation	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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026