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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02595385
Acronym
CONSERVE
Enrollment
240
Registered
2015-11-03
Start date
2015-02-28
Completion date
2016-08-31
Last updated
2015-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult Cardiac Surgery, Blood Transfusion

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.

Interventions

DEVICECell Salvage

Reinfusion of shed blood during the operation

PROCEDURERetrograde Autologous Prime

Removal of fluid from the bypass circuit

Sponsors

Belfast Health and Social Care Trust
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Number of units of packed red blood cells transfusedthrough study completion, an average of 2 weeks

Secondary

MeasureTime frame
Adverse reaction to RAP measured by systolic BP <90mmHg during initiation of bypass.intra-operatively

Countries

United Kingdom

Contacts

Primary Contactalison Murphy
alison.murphy@belfasttrust.hscni.net028 9063 6349
Backup ContactChristine Fawsett
info.orecni@hscni.net028 92 603107

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026