Coronary Artery DiseasePhase 4NCT01343381
Comparison of Heparin Types; Efficacy and Safety
A Phase 4 study testing Hepalean Heparin and PPC Heparin in people with Coronary Artery Disease, run by McMaster University at 1 site in Canada.
Trial 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? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Hepalean Heparin and PPC Heparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2011to Sep 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- will be undergoing cardiopulmonary bypass for coronary artery disease
- has provided written informed consent
Who cannot join
- Allergy or intolerance to Heparin
Trial locations and contacts
1 site in 1 country.
Canada1 site
Hamilton Health Sciences: Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
About this study
Official title: Anticoagulant Effect and Reversal of Hepalean Compared With PPC Heparin in Patients Undergoing Cardiopulmonary Bypass: a Pilot Randomized Trial
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?
- Conditions
- Coronary Artery Disease
- Being tested
- Hepalean Heparin, PPC Heparin
- Keywords
- Heparin, Coronary artery bypass graft surgery, Anti-coagulation efficacy
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepalean HeparinDrug
400 units per kilogram bolus prior to initiation of CPB
PPC HeparinDrug
400 unit per kilogram bolus prior to initiation of CPB
| Study group | Role | What they receive |
|---|---|---|
| Hepalean Heparin | Active comparator | Not described Receives: Drug: Hepalean Heparin |
| PPC Heparin | Active comparator | Not described Receives: Drug: PPC Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility to conduct a larger trial
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
Measured: pre-cardiopulmonary bypass initiation; peri-operative period (in minutes) to 24 hours post-operatively
Secondary outcomes (3)
ACT after initial dose of heparin
A dose of 400 units/kgm will be used
Measured: pre-cardiopulmonary bypass initiation; peri-operatively(in seconds)
Total Heparin Dose used
The total dose of heparin needed to maintain an ACT of 480 seconds throught bypass time.
Measured: pre-cardiopulmonary bypass initiation to termination of cardiopulmonary bypass; peri-operatively(in minutes)
Coagulation
aPTT, TCT, anti-Xa and anti IL IIa activity ant TAT levels after initial heparin dose and after 45 minutes on CPB.
Measured: post-cardiopulmonary inition, at the 45 minute on pump time point; perioperatively to 24 hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2011 (estimated)
- Study startJun 2011
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin H Teoh, MD, Principal investigator, Hamilton Health Sciences: Hamilton General Site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01343381
- Sponsor's protocol ID
- CANNeCTIN
- Status last verified
- May 2012
- First submitted
- 26 Apr 2011
- Last updated
- 15 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anticoagulant Effect and Reversal of Hepalean Compared With PPC Heparin in Patients Undergoing Cardiopulmonary Bypass: a Pilot Randomized Trial
- ClinicalTrials.gov ID
- NCT01343381
- Acronym / sponsor ID
- CANNeCTIN
- Conditions
- Coronary Artery Disease
- Keywords
- Heparin, Coronary artery bypass graft surgery, Anti-coagulation efficacy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 28 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hepalean Heparin | Active comparator | Drug: Hepalean Heparin |
| PPC Heparin | Active comparator | Drug: PPC Heparin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- will be undergoing cardiopulmonary bypass for coronary artery disease
- has provided written informed consent
Key exclusion criteria (1 listed)
- Allergy or intolerance to Heparin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hepalean Heparin400 units per kilogram bolus prior to initiation of CPB | Drug | Hepalean Heparin |
| PPC Heparin400 unit per kilogram bolus prior to initiation of CPB | Drug | PPC Heparin |
Primary outcome
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
3 secondary outcomes
ACT after initial dose of heparin
Time frame: pre-cardiopulmonary bypass initiation; peri-operatively(in seconds)
Total Heparin Dose used
Time frame: pre-cardiopulmonary bypass initiation to termination of cardiopulmonary bypass; peri-operatively(in minutes)
Coagulation
Time frame: post-cardiopulmonary inition, at the 45 minute on pump time point; perioperatively to 24 hours post-operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin H Teoh, MD principal investigator
Hamilton Health Sciences: Hamilton General Site
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hepalean Heparin and PPC Heparin in people with Coronary Artery Disease, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility to conduct a larger trial (time frame: pre-cardiopulmonary bypass initiation; peri-operative period (in minutes) to 24 hours post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2012.