Adult Cardiac SurgeryCONSERVENCT02595385
Blood Conservation in Adult Cardiac Surgery, What is the Way Forward in Today's Practice?
A study testing Cell Salvage and Retrograde Autologous Prime in people with Adult Cardiac Surgery and Blood Transfusion, run by Belfast Health and Social Care Trust at 1 site in United Kingdom.
Trial summary
The aim of this study is to compare retrograde autologous priming (RAP) of the bypass circuit to cell salvage (CS) as part of blood conservation strategies in adult cardiac surgery. It hypothesizes that RAP is at least as effective as cell salvage in terms of blood conservation but at the same time more cost effective. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Adult Cardiac Surgery, Blood Transfusion
- What is being tested?
- Cell Salvage and Retrograde Autologous Prime
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2015to Aug 2016
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Less than 80 years of age
- Undergoing single procedure surgery
- Be on single anti-platelet therapy
- To have stopped warfarin pre-operatively with a INR of <1.5
- Have stable coronary disease
- Have good Left Ventricular function
Who cannot join
- Redo procedures
- Emergency Surgery
- Be on dual antiplatelet therapy
- Have pre-operative kidney dysfunction with eGFR <60ml/min
- Have post-operative drainage >200ml per hour or require re-exploration for bleeding.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Department of Medicine
Belfast
Karen Booth, karen_booth@btopenworld.com
About this study
The aim of this study is to compare retrograde autologous priming (RAP) of the bypass circuit to cell salvage (CS) as part of blood conservation strategies in adult cardiac surgery. It hypothesizes that RAP is at least as effective as cell salvage in terms of blood conservation but at the same time more cost effective.
Read the detailed description
Cardiac surgery is a major blood consumer. Current evidence shows there is no benefit from transfusion for haematocrits as low as 21% and the risk of death within 30 days of surgery is almost 6 times higher for patients who receive blood. In addition, transfused patients are more likely to experience increased infections and ischaemic complications like myocardial infarction, stroke and renal compromise. While it is agreed to avoid blood transfusion when feasible, there is no current consensus on the best strategy to maintain an acceptable haemocrit and minimise the need for allogenic blood transfusion. Two of the many strategies that have been employed are Retrograde Autologous Prime (RAP) of the bypass circuit and cell salvage (CS) with reinfusion of shed blood.
This study is a prospective, randomised controlled trial with 240 patients undergoing a single procedure adult cardiac surgery that will be randomised to either full crystalloid prime volume or RAP, with or without cell salvage. There will be four study arms;
- RAP alone
- Cell Salvage alone
- RAP plus cell salvage
- Control group
Results will follow analyse of the data using a logistic regression using a design matric with blood transfused as a key explanatory variable with scope to add in patient covariables. It is expected that date will be analysed after 100 patients and if significance is achieved then the study can be terminated.
The study will aim to identify those patients that receive a blood transfusion intra or post-operatively. Symptomatology from anaemia is subjective and hard to measure. The studies linking transfusion to cardiac surgery outcomes are retrospective; despite careful risk adjustment, it is possible that these associations reflect a tendency amongst clinicians to transfuse the most critically ill patients or miss another important confounder.
In 2001, Spiess referred to current transfusion practice as a 'silent epidemic'. His description is still accurate. In 2006, almost half of all patients undergoing coronary artery bypass grafting in the united states received blood transfusion and the probability of receiving blood is greater when procedures are more complex. Although the infectious risk of blood transfusion have been successfully minimised the weight of evidence increasingly suggests that transfusing less in stable patients could prevent a significant amount of morbidity and mortality. This study will help guide management in those in whom transfusion is avoidable.
- Conditions
- Adult Cardiac Surgery, Blood Transfusion
- Being tested
- Cell Salvage, Retrograde Autologous Prime
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cell SalvageDevice
Reinfusion of shed blood during the operation
Retrograde Autologous PrimeProcedure or surgery
Removal of fluid from the bypass circuit
| Study group | Role | What they receive |
|---|---|---|
| RAP | Active comparator | Retrograde Autologous Prime of the bypass circuit. To remove 500-900ML of fluid. Receives: Procedure: Retrograde Autologous Prime |
| CS | Active comparator | Reinfusion of shed blood during the operation Receives: Device: Cell Salvage |
| RAP and CS | Active comparator | RAP and CS used in combination Receives: Device: Cell Salvage; Procedure: Retrograde Autologous Prime |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of units of packed red blood cells transfused
Measured: through study completion, an average of 2 weeks
Secondary outcomes (1)
Adverse reaction to RAP measured by systolic BP <90mmHg during initiation of bypass.
Measured: intra-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Cardiac SurgeryStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Belfast Health and Social Care Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alison Murphy, Belfast Health and Social Care Trust
- Investigators
- Reuben Jeganathan, Principal investigator, Belfast Health and Social Care Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02595385
- Sponsor's protocol ID
- 134964
- Acronym
- CONSERVE
- Status last verified
- Nov 2015
- First submitted
- 16 Oct 2015
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Conservation in Adult Cardiac Surgery, What is the Way Forward in Today's Practice?
- ClinicalTrials.gov ID
- NCT02595385
- Acronym / sponsor ID
- CONSERVE / 134964
- Conditions
- Adult Cardiac Surgery, Blood Transfusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Belfast Health and Social Care TrustUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 3 Nov 2015 (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 aim of this study is to compare retrograde autologous priming (RAP) of the bypass circuit to cell salvage (CS) as part of blood conservation strategies in adult cardiac surgery. It hypothesizes that RAP is at least as effective as cell salvage in terms of blood conservation but at the same time more cost effective.
Detailed description
Cardiac surgery is a major blood consumer. Current evidence shows there is no benefit from transfusion for haematocrits as low as 21% and the risk of death within 30 days of surgery is almost 6 times higher for patients who receive blood. In addition, transfused patients are more likely to experience increased infections and ischaemic complications like myocardial infarction, stroke and renal compromise. While it is agreed to avoid blood transfusion when feasible, there is no current consensus on the best strategy to maintain an acceptable haemocrit and minimise the need for allogenic blood transfusion. Two of the many strategies that have been employed are Retrograde Autologous Prime (RAP) of the bypass circuit and cell salvage (CS) with reinfusion of shed blood.
This study is a prospective, randomised controlled trial with 240 patients undergoing a single procedure adult cardiac surgery that will be randomised to either full crystalloid prime volume or RAP, with or without cell salvage. There will be four study arms;
- RAP alone
- Cell Salvage alone
- RAP plus cell salvage
- Control group
Results will follow analyse of the data using a logistic regression using a design matric with blood transfused as a key explanatory variable with scope to add in patient covariables. It is expected that date will be analysed after 100 patients and if significance is achieved then the study can be terminated.
The study will aim to identify those patients that receive a blood transfusion intra or post-operatively. Symptomatology from anaemia is subjective and hard to measure. The studies linking transfusion to cardiac surgery outcomes are retrospective; despite careful risk adjustment, it is possible that these associations reflect a tendency amongst clinicians to transfuse the most critically ill patients or miss another important confounder.
In 2001, Spiess referred to current transfusion practice as a 'silent epidemic'. His description is still accurate. In 2006, almost half of all patients undergoing coronary artery bypass grafting in the united states received blood transfusion and the probability of receiving blood is greater when procedures are more complex. Although the infectious risk of blood transfusion have been successfully minimised the weight of evidence increasingly suggests that transfusing less in stable patients could prevent a significant amount of morbidity and mortality. This study will help guide management in those in whom transfusion is avoidable.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| RAP | Active comparator | Procedure: Retrograde Autologous PrimeRetrograde Autologous Prime of the bypass circuit. To remove 500-900ML of fluid. |
| CS | Active comparator | Device: Cell SalvageReinfusion of shed blood during the operation |
| RAP and CS | Active comparator | Device: Cell Salvage, Procedure: Retrograde Autologous PrimeRAP and CS used in combination |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Less than 80 years of age
- Undergoing single procedure surgery
- Be on single anti-platelet therapy
- To have stopped warfarin pre-operatively with a INR of <1.5
- Have stable coronary disease
Key exclusion criteria (5 listed)
- Redo procedures
- Emergency Surgery
- Be on dual antiplatelet therapy
- Have pre-operative kidney dysfunction with eGFR <60ml/min
- Have post-operative drainage >200ml per hour or require re-exploration for bleeding.
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 |
|---|---|---|
| Cell SalvageReinfusion of shed blood during the operation | Device | CS, RAP and CS |
| Retrograde Autologous PrimeRemoval of fluid from the bypass circuit | Procedure or surgery | RAP, RAP and CS |
Primary outcome
Number of units of packed red blood cells transfused
Time frame: through study completion, an average of 2 weeks
1 secondary outcome
Adverse reaction to RAP measured by systolic BP <90mmHg during initiation of bypass.
Time frame: intra-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2015.
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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.
Reuben Jeganathan principal investigator
Belfast Health and Social Care Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cell Salvage and Retrograde Autologous Prime in people with Adult Cardiac Surgery and Blood Transfusion, run by Belfast Health and Social Care Trust at 1 site in United Kingdom.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 3 Nov 2015. 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 Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact alison Murphy (028 9063 6349, alison.murphy@belfasttrust.hscni.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of units of packed red blood cells transfused (time frame: through study completion, an average of 2 weeks). 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 3 Nov 2015.