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

NCT ID: NCT02595385

Last Updated: 2015-11-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2016-08-31

Brief 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.

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.

Conditions

Adult Cardiac Surgery; Blood Transfusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

RAP

Retrograde Autologous Prime of the bypass circuit. To remove 500-900ML of fluid.

Group Type: ACTIVE_COMPARATOR

Retrograde Autologous Prime

Intervention Type: PROCEDURE

Removal of fluid from the bypass circuit

CS

Reinfusion of shed blood during the operation

Group Type: ACTIVE_COMPARATOR

Cell Salvage

Intervention Type: DEVICE

Reinfusion of shed blood during the operation

RAP and CS

RAP and CS used in combination

Group Type: ACTIVE_COMPARATOR

Cell Salvage

Intervention Type: DEVICE

Reinfusion of shed blood during the operation

Retrograde Autologous Prime

Intervention Type: PROCEDURE

Removal of fluid from the bypass circuit

Control

No intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cell Salvage

Reinfusion of shed blood during the operation

Intervention Type: DEVICE

Retrograde Autologous Prime

Removal of fluid from the bypass circuit

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Belfast Health and Social Care Trust

OTHER

Sponsor Role: lead

Responsible Party

Alison Murphy

Research Administrator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Reuben Jeganathan

Role: PRINCIPAL_INVESTIGATOR

Belfast Health and Social Care Trust

Locations

Department of Medicine

Belfast, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

alison Murphy

Role: CONTACT

alison.murphy@belfasttrust.hscni.net

028 9063 6349

Christine Fawsett

Role: CONTACT

info.orecni@hscni.net

028 92 603107

Facility Contacts

Karen Booth

Role: primary

karen_booth@btopenworld.com

Other Identifiers

134964

Identifier Type: -

Identifier Source: org_study_id