Blood Conservation in Adult Cardiac Surgery, What is the Way Forward in Today's Practice? (CONSERVE)

November 2, 2015 updated by: Alison Murphy, Belfast Health and Social Care Trust
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
No intervention
Active Comparator: RAP
Retrograde Autologous Prime of the bypass circuit. To remove 500-900ML of fluid.
Procedure: Retrograde Autologous Prime
Removal of fluid from the bypass circuit
Active Comparator: CS
Reinfusion of shed blood during the operation
Device: Cell Salvage
Reinfusion of shed blood during the operation
Active Comparator: RAP and CS
RAP and CS used in combination
Procedure: Retrograde Autologous Prime
Removal of fluid from the bypass circuit
Device: Cell Salvage
Reinfusion of shed blood during the operation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of units of packed red blood cells transfused
Time Frame: through study completion, an average of 2 weeks
through study completion, an average of 2 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Adverse reaction to RAP measured by systolic BP <90mmHg during initiation of bypass.
Time Frame: intra-operatively
intra-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Belfast Health and Social Care Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Reuben Jeganathan, Belfast Health and Social Care Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 16, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 3, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 3, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 134964

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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