Retransfusion or Not of Cardiotomy Blood
Primary Purpose
Blood Loss, Surgical
Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
No retransfusion of cardiotomy blood
Sponsored by
About this trial
This is an interventional treatment trial for Blood Loss, Surgical
Eligibility Criteria
Inclusion Criteria:
- Elective CABG.
Exclusion Criteria:
- Anaemia, infection, massive bleeding, CABG off pump.
Sites / Locations
- University Hospital in Örebro
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Retransfusion of cardiotomy blood or not
No retransfusion of cardiotomy blood
Arm Description
Intervention group does not get cardiotomy blood retransfusion via heart-and lung machine while control does.
Outcomes
Primary Outcome Measures
blood loss
Hemoglobin
Blood loss
Blood volume in millilitre (mL)
Secondary Outcome Measures
Full Information
NCT ID
NCT04574128
First Posted
September 21, 2020
Last Updated
September 28, 2020
Sponsor
Örebro University, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT04574128
Brief Title
Retransfusion or Not of Cardiotomy Blood
Official Title
Blood Loss With Cardiopulmonary Bypass, Re-transfusion or Not.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2020 (Anticipated)
Primary Completion Date
August 30, 2021 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Örebro University, Sweden
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss, Surgical
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Randomised controlled non-inferiority trial
Masking
ParticipantCare Provider
Masking Description
The person that controle the heart- and lung mashine is not masked. Other members of the surgical team is masked.
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Retransfusion of cardiotomy blood or not
Arm Type
Experimental
Arm Description
Intervention group does not get cardiotomy blood retransfusion via heart-and lung machine while control does.
Arm Title
No retransfusion of cardiotomy blood
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
No retransfusion of cardiotomy blood
Intervention Description
No retransfusion of cardiotomy blood via heart- and lung mashine
Primary Outcome Measure Information:
Title
blood loss
Description
Hemoglobin
Time Frame
During 5 days hemoglobin will be measured as the clinical rutine or as needed.
Title
Blood loss
Description
Blood volume in millilitre (mL)
Time Frame
During 2 days or while surgical drains remains, blood volume in mL is measured.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Elective CABG.
Exclusion Criteria:
Anaemia, infection, massive bleeding, CABG off pump.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Camilla Wistrand, PhD
Phone
+460707686938
Email
camilla.wistrand@regionorebrolan.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Camilla Wistrand, PhD
Organizational Affiliation
Örebro University, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital in Örebro
City
Örebro
ZIP/Postal Code
70185
Country
Sweden
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camilla Wistrand, PhD
Phone
+46707686938
Email
camilla.wistrand@regionorebrolan.se
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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.
Learn more about this trial
Retransfusion or Not of Cardiotomy Blood
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