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

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: Unknown
• Conditions: Blood Transfusion; Adult Cardiac Surgery
• Intervention / Treatment: Procedure: Retrograde Autologous Prime; Device: Cell Salvage

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: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: alison Murphy; Phone Number: 028 9063 6349; Email: alison.murphy@belfasttrust.hscni.net
• Study Contact Backup: Name: Christine Fawsett; Phone Number: 028 92 603107; Email: info.orecni@hscni.net

Study Locations

• United Kingdom
  • Belfast, United Kingdom
    • Recruiting
    • Department of Medicine
    • Contact: Karen Booth; Email: karen_booth@btopenworld.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Number of units of packed red blood cells transfused	through study completion, an average of 2 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse reaction to RAP measured by systolic BP <90mmHg during initiation of bypass.	intra-operatively

Collaborators and Investigators

• Sponsor: Belfast Health and Social Care Trust
• Investigators: Principal Investigator: Reuben Jeganathan, Belfast Health and Social Care Trust

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Anticipated): February 1, 2016
• Study Completion (Anticipated): August 1, 2016

Study Registration Dates

• First Submitted: October 16, 2015
• First Submitted That Met QC Criteria: November 2, 2015
• First Posted (Estimate): November 3, 2015

Study Record Updates

• Last Update Posted (Estimate): November 3, 2015
• Last Update Submitted That Met QC Criteria: November 2, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 134964