Blood Conservation in Adult Cardiac Surgery, What is the Way Forward in Today's Practice?
CONSERVE
1 other identifier
interventional
240
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 16, 2015
CompletedFirst Posted
Study publicly available on registry
November 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedNovember 3, 2015
November 1, 2015
1 year
October 16, 2015
November 2, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Number of units of packed red blood cells transfused
through study completion, an average of 2 weeks
Secondary Outcomes (1)
Adverse reaction to RAP measured by systolic BP <90mmHg during initiation of bypass.
intra-operatively
Study Arms (4)
RAP
ACTIVE COMPARATORRetrograde Autologous Prime of the bypass circuit. To remove 500-900ML of fluid.
CS
ACTIVE COMPARATORReinfusion of shed blood during the operation
RAP and CS
ACTIVE COMPARATORRAP and CS used in combination
Control
NO INTERVENTIONNo intervention
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Medicine
Belfast, United Kingdom
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Reuben Jeganathan
Belfast Health and Social Care Trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Administrator
Study Record Dates
First Submitted
October 16, 2015
First Posted
November 3, 2015
Study Start
February 1, 2015
Primary Completion
February 1, 2016
Study Completion
August 1, 2016
Last Updated
November 3, 2015
Record last verified: 2015-11