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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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
  • Department of Medicine

    Belfast

    Karen Booth, karen_booth@btopenworld.com

    Recruiting

Other trials in United Kingdom

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;

  1. RAP alone
  2. Cell Salvage alone
  3. RAP plus cell salvage
  4. 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.

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 groups in NCT02595385
Study groupRoleWhat they receive
RAPActive comparatorRetrograde Autologous Prime of the bypass circuit. To remove 500-900ML of fluid.
Receives: Procedure: Retrograde Autologous Prime
CSActive comparatorReinfusion of shed blood during the operation
Receives: Device: Cell Salvage
RAP and CSActive comparatorRAP and CS used in combination
Receives: Device: Cell Salvage; Procedure: Retrograde Autologous Prime
ControlNo interventionNo intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of units of packed red blood cells transfused

    Measured: through study completion, an average of 2 weeks

Secondary outcomes (1)
  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.

  1. First posted3 Nov 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completionFeb 2016 (estimated)
  4. Study completionAug 2016 (estimated)

Resources

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)
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

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.

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