Postoperative HemorrhagePhase 3Heparin DosingNCT00587444
Optimal Heparin Dosing Regimens for Cardiopulmonary Bypass
A Phase 3 study testing Heparin, HH or high heparin and heparin concentration HC in people with Postoperative Hemorrhage, run by Mayo Clinic at 1 site in United States.
Trial summary
Study has been completed and is in the data analysis and manuscript writing phase of the project. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Postoperative Hemorrhage
- What is being tested?
- Heparin, HH or high heparin and heparin concentration HC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2001to Oct 2007
- Phase
- Phase 3
- 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
- Adult male and non-pregnant female patients scheduled for elective cardiac surgery requiring CPB will be eligible for enrollment.
Who cannot join
- Age less than 18 or greater than 90 years; emergency surgery
- Circulatory arrest
- Combined non-cardiac procedures such as carotid endarterectomy
- Congenital heart repair
- Off-CPB coronary artery bypass grafting (CABG)
- Clotting disorder
Show all 11Show fewer
- Fibrinolytic agents (e.g. streptokinase), severe hepatic disease
- Aprotinin use
- Cooling < 28 degrees C during CPB
- Dialysis dependent renal failure; and
- Platelet receptor GP3a/2b antagonists medication received within 48 hours of surgery. Patients that are not receiving tranexamic acid (TA) intraoperatively will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Study has been completed and is in the data analysis and manuscript writing phase of the project.
- Conditions
- Postoperative Hemorrhage
- Being tested
- Heparin, HH or high heparin, heparin concentration HC
- Keywords
- heparin management
- Medical subject headings
- Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeparinDrug
300u/kg of heparin for CPB ACT performed. If ACT is < 480 seconds a bolus of 5000u heparin will be given. ACT will be repeated and bolus given until ACT is>480 seconds
HH or high heparinDrug
initial dose of 450u/kg for CPB ACT performed additional bolus given if result is <600 seconds anytime during CPB
heparin concentration HCDrug
will have anticoagulation during CPB assessed with heparin concentration monitoring and heparin dose response (HDR) to determine the optimal dosage of heparin. This group will evaluate the possible benefit of the HDR to determine heparin dosing and monitoring to achieve maximal suppression of thrombin compared to a fixed dose of heparin as the other two groups. Additional heparin doses will be given to maintain a specific heparin concentration according to the HDR. This is a recognized way of managing heparin dosing and anticoagulation for CPB.
All three groups will have heparin neutralized by protamine. Adequacy of heparin neutralization will be based on a difference between the ACT and heparinase-treated ACT values of less than 10%
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | control standard dose heparin dose Receives: Drug: Heparin |
| 2 | Active comparator | high dose heparin dose Receives: Drug: HH or high heparin |
| 3 | Active comparator | hepcon guided therapy Receives: Drug: heparin concentration HC |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure blood loss
Measured: within 48 hours
Secondary outcomes (1)
transfusion requirements
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2008 (estimated)
- Study startJun 2001
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative HemorrhageStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Investigators
- William Oliver, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00587444
- Sponsor's protocol ID
- 330-01
- Other IDs
- 3300100, CR4023159908
- Acronym
- Heparin Dosing
- Status last verified
- Oct 2009
- First submitted
- 21 Dec 2007
- Last updated
- 15 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Heparin Dosing Regimens for Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT00587444
- Acronym / sponsor ID
- Heparin Dosing / 330-01
- Conditions
- Postoperative Hemorrhage
- Keywords
- heparin management
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Jun 2001
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 7 Jan 2008 (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.
Study has been completed and is in the data analysis and manuscript writing phase of the project.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: Heparincontrol standard dose heparin dose |
| 2 | Active comparator | Drug: HH or high heparinhigh dose heparin dose |
| 3 | Active comparator | Drug: heparin concentration HChepcon guided therapy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult male and non-pregnant female patients scheduled for elective cardiac surgery requiring CPB will be eligible for enrollment.
Key exclusion criteria (11 listed)
- Age less than 18 or greater than 90 years; emergency surgery
- Circulatory arrest
- Combined non-cardiac procedures such as carotid endarterectomy
- Congenital heart repair
- Off-CPB coronary artery bypass grafting (CABG)
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 |
|---|---|---|
| Heparin300u/kg of heparin for CPB ACT performed. If ACT is < 480 seconds a bolus of 5000u heparin will be given. ACT will be repeated and bolus given until ACT is>480 seconds | Drug | 1 |
| HH or high heparininitial dose of 450u/kg for CPB ACT performed additional bolus given if result is <600 seconds anytime during CPB | Drug | 2 |
| heparin concentration HCwill have anticoagulation during CPB assessed with heparin concentration monitoring and heparin dose response (HDR) to determine the optimal dosage of heparin. This group will evaluate the possible benefit of the HDR to determine heparin dosing and monitoring to achieve maximal suppression of thrombin compared to a fixed dose of heparin as the other two groups. Additional heparin doses will be given to maintain a specific heparin concentration according to the HDR. This is a recognized way of managing heparin dosing and anticoagulation for CPB. All three groups will have heparin neutralized by protamine. Adequacy of heparin neutralization will be based on a difference between the ACT and heparinase-treated ACT values of less than 10% | Drug | 3 |
Primary outcome
measure blood loss
Time frame: within 48 hours
1 secondary outcome
transfusion requirements
Time frame: 48 hours
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 Oct 2009.
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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.
William Oliver, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Heparin, HH or high heparin and heparin concentration HC in people with Postoperative Hemorrhage, run by Mayo Clinic at 1 site in United States.
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 1 inclusion and 11 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 Oct 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 United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
measure blood loss (time frame: within 48 hours). 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 Oct 2009.