Cardiac SurgeryNCT00646373
Effect of Decreased Pump Prime Volume on Blood Transfusions and Postoperative Complications of Patients Undergoing High Risk Cardiac Surgical Procedures
A study testing Low Prime in people with Cardiac Surgery, run by University Health Network, Toronto.
Trial summary
The objective of this study is to evaluate the impact of reduced pump prime on blood transfusions and postoperative complications in patients at high risk of severe hemodilution during CPB. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- Low Prime
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Dec 2006to Dec 2006
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 y of age
- Non-emergent complex cardiac surgery (any procedure other than primary isolated CABG)
- Any of the following: Hb < 120 g/L (Females) or < 130 g/L (Males)BSA < 1.6 m2Creatinine Clearance < 60 mL/min (Cockcroft Gault Equation)
Who cannot join
- aPTT >50 s, INR>1.5
- Plt < 100,000 x 106
- Preoperative Hemodialysis
- Tight aortic stenosis (Aortic Valve Area < 1 cm2)
- Tight lesion of the left main coronary artery (> 60%)
- Use of Aprotinin requested by the Surgical Team
About this study
Official title: Effect of Decreased Pump Prime Volume on Blood Transfusions and Postoperative Complications of Patients Undergoing High Risk Cardiac Surgical Procedures: A Pilot Study
The objective of this study is to evaluate the impact of reduced pump prime on blood transfusions and postoperative complications in patients at high risk of severe hemodilution during CPB.
HYPOTHESIS The use of a new CPB circuit with a smaller internal volume, together with retrograde autologous priming of the lines (RAP) will allow a smaller prime volume and therefore less significant hemodilution on pump.
Read more
EXPERIMENTAL DESIGN Overview
Patients will be randomized on the morning of surgery to one of the two study groups in a 1:1 allocation scheme:
- Low pump prime
- Standard pump prime Outcomes The primary outcome is the number of units of blood products transfused within the first 24 hours post CPB.
- Conditions
- Cardiac Surgery
- Being tested
- Low Prime
- Keywords
- Cardiac surgery, Pump prime, Blood transfusions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low PrimeOther
The CPB circuit will be primed with mannitol (50 g of 20% solution) and crystalloid solution (Ringer's lactate) for a total volume of approximately 1200 ml.
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of units of blood products transfused within the first 24 hours post CPB.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2008 (estimated)
- Study startDec 2006
- Primary completionDec 2006
Why it stopped: Protocol was comparing to standard of practice, which has changed over the course of slow recruitment and no longer can be used as a comparator.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00646373
- Sponsor's protocol ID
- UHN REB#06-0012-B
- Status last verified
- Dec 2006
- First submitted
- 25 Mar 2008
- Last updated
- 20 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Decreased Pump Prime Volume on Blood Transfusions and Postoperative Complications of Patients Undergoing High Risk Cardiac Surgical Procedures: A Pilot Study
- ClinicalTrials.gov ID
- NCT00646373
- Acronym / sponsor ID
- UHN REB#06-0012-B
- Conditions
- Cardiac Surgery
- Keywords
- Cardiac surgery, Pump prime, Blood transfusions
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Protocol was comparing to standard of practice, which has changed over the course of slow recruitment and no longer can be used as a comparator.
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Dec 2006 (actual)
- First posted
- 28 Mar 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.
The objective of this study is to evaluate the impact of reduced pump prime on blood transfusions and postoperative complications in patients at high risk of severe hemodilution during CPB.
HYPOTHESIS The use of a new CPB circuit with a smaller internal volume, together with retrograde autologous priming of the lines (RAP) will allow a smaller prime volume and therefore less significant hemodilution on pump.
EXPERIMENTAL DESIGN Overview
Patients will be randomized on the morning of surgery to one of the two study groups in a 1:1 allocation scheme:
- Low pump prime
- Standard pump prime Outcomes The primary outcome is the number of units of blood products transfused within the first 24 hours post CPB.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >18 y of age
- Non-emergent complex cardiac surgery (any procedure other than primary isolated CABG)
- Any of the following: Hb < 120 g/L (Females) or < 130 g/L (Males)BSA < 1.6 m2Creatinine Clearance < 60 mL/min (Cockcroft Gault Equation)
Key exclusion criteria (6 listed)
- aPTT >50 s, INR>1.5
- Plt < 100,000 x 106
- Preoperative Hemodialysis
- Tight aortic stenosis (Aortic Valve Area < 1 cm2)
- Tight lesion of the left main coronary artery (> 60%)
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 |
|---|---|---|
| Low PrimeThe CPB circuit will be primed with mannitol (50 g of 20% solution) and crystalloid solution (Ringer's lactate) for a total volume of approximately 1200 ml. | Other | – |
Primary outcome
The number of units of blood products transfused within the first 24 hours post CPB.
Time frame: 24 hours
Results and safety
The study was stopped early (reason given: Protocol was comparing to standard of practice, which has changed over the course of slow recruitment and no longer can be used as a comparator.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Low Prime in people with Cardiac Surgery, run by University Health Network, Toronto.
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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 20 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: Protocol was comparing to standard of practice, which has changed over the course of slow recruitment and no longer can be used as a comparator.). Results are not available in the source record.
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?
The number of units of blood products transfused within the first 24 hours post CPB. (time frame: 24 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 20 Apr 2011.