Retransfusion or Not of Cardiotomy Blood
Blood Loss With Cardiopulmonary Bypass, Re-transfusion or Not.
1 other identifier
interventional
40
1 country
1
Brief Summary
This randomised controlled trial has a non-inferiority design. The aim is to test if the blood loss (volume in mL and hemoglobin) is effected by heart and lung cardiotomy retransfusion, or not? Forty CABG (Coronary Artery By pass Grafting) patients will be allocated to either receive retransfusion (n=20) of cardiotomy blood via the heart and lung mashine, or no retransfusion (n=20).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2020
Typical duration for not_applicable
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
First Submitted
Initial submission to the registry
September 21, 2020
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedFirst Posted
Study publicly available on registry
October 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2022
CompletedOctober 5, 2020
September 1, 2020
11 months
September 21, 2020
September 28, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
blood loss
Hemoglobin
During 5 days hemoglobin will be measured as the clinical rutine or as needed.
Blood loss
Blood volume in millilitre (mL)
During 2 days or while surgical drains remains, blood volume in mL is measured.
Study Arms (2)
Retransfusion of cardiotomy blood or not
EXPERIMENTALIntervention group does not get cardiotomy blood retransfusion via heart-and lung machine while control does.
No retransfusion of cardiotomy blood
NO INTERVENTIONInterventions
No retransfusion of cardiotomy blood via heart- and lung mashine
Eligibility Criteria
You may qualify if:
- Elective CABG.
You may not qualify if:
- Anaemia, infection, massive bleeding, CABG off pump.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital in Örebro
Örebro, 70185, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Camilla Wistrand, PhD
Örebro University, Sweden
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Masking Details
- The person that controle the heart- and lung mashine is not masked. Other members of the surgical team is masked.
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2020
First Posted
October 5, 2020
Study Start
October 1, 2020
Primary Completion
August 30, 2021
Study Completion
December 30, 2022
Last Updated
October 5, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share
The datasets generated and/or analysed during the current study are not publicly available due to ethical considerations of the participant integrity. Bacterial growth can be seen as sensitive data. The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.