Coronary Artery Bypass GraftingNCT00848796
Comparative Study of Two Brands of Heparin Already on the Market
A study testing Heparin Leo and Hepalean in people with Coronary Artery Bypass Grafting, run by Southlake Health at 1 site in Canada.
Trial summary
Two heparin brands have been in the market in Canada for several years. Heparin Leo from Leo Pharma and Hepalean from Organon. The former is standardized by B.P (British pharmacopeia) while the latter is standardized by U.S.P (United states pharmacopeia). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Artery Bypass Grafting
- What is being tested?
- Heparin Leo and Hepalean
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2006to Dec 2007
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Isolated Coronary Artery Bypass Surgery
- Normal Hematocrit
- Normal Creatinine
- Normal Liver function
Who cannot join
- Re-do
- Combination procedure
- Valve repair/replacement
- IABP-pre/Intra/Post-op
- Cell saver intra-op
- Anemia (70 g/L)/Bleeding disorder, e.g.,: Jehovah's witness, hemophilia etc.
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- Use of aprotinin
- Small adult < 50 kg
- Aortic surgery with/without circ. arrest
- Emergent patient with heart failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Do Different Heparin Brands Influence Bleeding in Coronary Surgery
Two heparin brands have been in the market in Canada for several years. Heparin Leo from Leo Pharma and Hepalean from Organon. The former is standardized by B.P (British pharmacopeia) while the latter is standardized by U.S.P (United states pharmacopeia). Previous studies have shown Heparin Leo to have roughly a 10% less efficacy then Hepalean. It has also been demonstrated that more protamine is required to reverse Heparin Leo. It is the investigators' intention to study the post-operative effects of the two brands of heparin and whether one of the two causes less bleeding after bypass surgery.
Read the detailed description
The study protocol attempts not to change the normal protocol for cardiac surgery too much.
The two different brands of heparin-Heparin Leo (Leo pharma) and Hepalean (Organon) are randomized by the float perfusionist using the program research randomizer.A 50 ml syringe is loaded with heparin for the Anesthesiologist and labelled. A 20 ml syringe is loaded with heparin and thenn labelled. It is a double blinded trial with the surgeon and anesthetist not knowing which brand heparin is being used. All cases are isolated Coronary Artery Bypass Grafting (C.A.B.G) with no concomittant conditions. The following are the patients excluded from the trial
- RE-DO
- COMBINATION PROCEDURE
- VALVE REPAIR/REPLACEMENT
- IABP-PRE/INTRA//POST-OP
- CELL SAVER INTRA-OP
- ANEMIA (70 g/L)/BLEEDING DISORDER eg:Jehovah's witness,hemophilia etc.
- USE OF APROTININ
- SMALL ADULT < 50 KG
- AORTIC SURGERY WITH/WITHOUT CIRC ARREST
- EMERGENT PATIENT WITH HEART FAILURE
Heparin will be administered in the trial to elevate the A.C.T-Activated clotting time to 480 s and above and the heparin level to 300u/Kg to intiate cardio-pulmonary bypass (C.P.B). Additional heparin will be given to maintain the above-mentioned levels.
The following data will be studied
- BSA
- Height
- Weight
- Diagnosis
- Procedure
- Surgeon
- Anesthetist
- Perfusionist
Pre pump Hb Pump Hb Post pump Hb
Pre pump ACT Pump ACT Post pump ACT
Projected heparin conc. Slope Protocol heparin conc Heparin time CPB time X-clamp time Heparin (initial dose) Extra heparin on pump Prime Volume RAP Volume Pump balance ml Urine output ml Average temp on CPB Phenylephrine Amt Levofed amt Creatinine AST Calculated protamine dose at the end of the case Extra protamine given Total protamine CBC after pump Total chest tube drainage in OR ml Total patient in OR time
Pre pump Post Pump Platelet INR PTT PT
Date Time NA Plavix stopped ASA stopped Heparin stopped Coumadin stopped
FFP given Total packed cells given Total platelets given Other factors given Other blood product given Ca2+ given DDAVP given
Post-op 6 hrs 12 hrs 24 hrs Chest tube drainage (ml) Chest tube removed time Hct Platelet INR PTT
ADDITIONS Packed cells Cryo Platelets Other blood product / factors
Chest reopening Yes No The reason if yes Patient transfer date- Time
Overall we are going to look at whether their is any impact on post-operative bleeding,hospital and ICU stay.
- Conditions
- Coronary Artery Bypass Grafting
- Being tested
- Heparin Leo and Hepalean
- Keywords
- Heparin Leo, Hepalean, CPB Cardiopuilmonary Bypass, CABG Coronary Artery Bypass Grafting, Anticoagulation efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heparin Leo and HepaleanDrug
Also called Heparin Leo, Hepalean
Dosage based on Heparin does response curve obtained from the Medtronic HMS plus
| Study group | Role | What they receive |
|---|---|---|
| Heparin | Other | Compare two market brands of Heparin Receives: Drug: Heparin Leo and Hepalean |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest tube drainage
Measured: 24 to 48 hrs
Secondary outcomes (3)
Amount of heparin used
Measured: 1 to 7 hrs
Amount of Protamine used
Measured: 1 to 7 hrs
Measured slope with heparin/ACT titration
Measured: 1 to 7 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2009 (estimated)
- Study startSep 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Bypass GraftingStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southlake Health
- Sponsor type
- University, hospital or other
- Investigators
- Charles M Peniston, MD,FRCP, Principal investigator, Department of Cardiac surgery-S.R.H.C
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00848796
- Sponsor's protocol ID
- southlake
- Status last verified
- Feb 2009
- First submitted
- 19 Feb 2009
- Last updated
- 20 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Dyck L, Friesen RM. Do different heparin brands influence activated clotting times? J Extra Corpor Technol. 1998 Jun;30(2):73-6.
PubMed 10182116
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Different Heparin Brands Influence Bleeding in Coronary Surgery
- ClinicalTrials.gov ID
- NCT00848796
- Acronym / sponsor ID
- southlake
- Conditions
- Coronary Artery Bypass Grafting
- Keywords
- Heparin Leo, Hepalean, CPB Cardiopuilmonary Bypass, CABG Coronary Artery Bypass Grafting, Anticoagulation efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Southlake HealthUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 20 Feb 2009 (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.
Two heparin brands have been in the market in Canada for several years. Heparin Leo from Leo Pharma and Hepalean from Organon. The former is standardized by B.P (British pharmacopeia) while the latter is standardized by U.S.P (United states pharmacopeia). Previous studies have shown Heparin Leo to have roughly a 10% less efficacy then Hepalean. It has also been demonstrated that more protamine is required to reverse Heparin Leo. It is the investigators' intention to study the post-operative effects of the two brands of heparin and whether one of the two causes less bleeding after bypass surgery.
Detailed description
The study protocol attempts not to change the normal protocol for cardiac surgery too much.
The two different brands of heparin-Heparin Leo (Leo pharma) and Hepalean (Organon) are randomized by the float perfusionist using the program research randomizer.A 50 ml syringe is loaded with heparin for the Anesthesiologist and labelled. A 20 ml syringe is loaded with heparin and thenn labelled. It is a double blinded trial with the surgeon and anesthetist not knowing which brand heparin is being used. All cases are isolated Coronary Artery Bypass Grafting (C.A.B.G) with no concomittant conditions. The following are the patients excluded from the trial
- RE-DO
- COMBINATION PROCEDURE
- VALVE REPAIR/REPLACEMENT
- IABP-PRE/INTRA//POST-OP
- CELL SAVER INTRA-OP
- ANEMIA (70 g/L)/BLEEDING DISORDER eg:Jehovah's witness,hemophilia etc.
- USE OF APROTININ
- SMALL ADULT < 50 KG
- AORTIC SURGERY WITH/WITHOUT CIRC ARREST
- EMERGENT PATIENT WITH HEART FAILURE
Heparin will be administered in the trial to elevate the A.C.T-Activated clotting time to 480 s and above and the heparin level to 300u/Kg to intiate cardio-pulmonary bypass (C.P.B). Additional heparin will be given to maintain the above-mentioned levels.
The following data will be studied
- BSA
- Height
- Weight
- Diagnosis
- Procedure
- Surgeon
- Anesthetist
- Perfusionist
Pre pump Hb Pump Hb Post pump Hb
Pre pump ACT Pump ACT Post pump ACT
Projected heparin conc. Slope Protocol heparin conc Heparin time CPB time X-clamp time Heparin (initial dose) Extra heparin on pump Prime Volume RAP Volume Pump balance ml Urine output ml Average temp on CPB Phenylephrine Amt Levofed amt Creatinine AST Calculated protamine dose at the end of the case Extra protamine given Total protamine CBC after pump Total chest tube drainage in OR ml Total patient in OR time
Pre pump Post Pump Platelet INR PTT PT
Date Time NA Plavix stopped ASA stopped Heparin stopped Coumadin stopped
FFP given Total packed cells given Total platelets given Other factors given Other blood product given Ca2+ given DDAVP given
Post-op 6 hrs 12 hrs 24 hrs Chest tube drainage (ml) Chest tube removed time Hct Platelet INR PTT
ADDITIONS Packed cells Cryo Platelets Other blood product / factors
Chest reopening Yes No The reason if yes Patient transfer date- Time
Overall we are going to look at whether their is any impact on post-operative bleeding,hospital and ICU stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heparin | Other | Drug: Heparin Leo and HepaleanCompare two market brands of Heparin |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Isolated Coronary Artery Bypass Surgery
- Normal Hematocrit
- Normal Creatinine
- Normal Liver function
Key exclusion criteria (10 listed)
- Re-do
- Combination procedure
- Valve repair/replacement
- IABP-pre/Intra/Post-op
- Cell saver intra-op
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 |
|---|---|---|
| Heparin Leo and HepaleanAlso: Heparin Leo, HepaleanDosage based on Heparin does response curve obtained from the Medtronic HMS plus | Drug | Heparin |
Primary outcome
Chest tube drainage
Time frame: 24 to 48 hrs
3 secondary outcomes
Amount of heparin used
Time frame: 1 to 7 hrs
Amount of Protamine used
Time frame: 1 to 7 hrs
Measured slope with heparin/ACT titration
Time frame: 1 to 7 hrs
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 20 Feb 2009.
- Results publication: PubMed 10182116Dyck L, Friesen RM. Do different heparin brands influence activated clotting times? J Extra Corpor Technol. 1998 Jun;30(2):73-6.
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Coronary Artery Disease, Left Ventricular Systolic Dysfunction
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Preoperative Gastric Ultrasound and Anaesthetic Management in Patients Undergoing Coronary Artery Bypass Grafting
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Coronary Artery Bypass Graft (CABG)
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.
Charles M Peniston, MD,FRCP principal investigator
Department of Cardiac surgery-S.R.H.C
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heparin Leo and Hepalean in people with Coronary Artery Bypass Grafting, run by Southlake Health 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 4 inclusion and 10 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 20 Feb 2009. 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.
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?
Chest tube drainage (time frame: 24 to 48 hrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00848796, which also lists 1 linked publication.
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 20 Feb 2009.