Red Blood Cells (RBC) Transfusion Related to Central Venous O2 Saturation (ScvO2) Measurement
Primary Purpose
Postoperative Complications, Erythrocyte Transfusion, Oxygen Disorders
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Transfusion
Transfusion
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Complications focused on measuring Postoperative Care, red blood cell transfusion, venous oxygen saturation
Eligibility Criteria
Inclusion Criteria:
- central venous catheter
- anemia With reference to french consensus about transfusion
Exclusion Criteria:
- intensive care
- emergency transfusion
- shock, hypovolemia
- need to go under surgery into 4 hours
- acute kidney injury or chronic renal disease
- brain injury
- pregnancy
- heart disease : ischemia <1 mois
Sites / Locations
- university Hospital, lille
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SCVO2 < 70%
currently intervention
Arm Description
guidelines transfusion + SCVO2 < 70%
guidelines transfusion
Outcomes
Primary Outcome Measures
Number of RBC units transfused by group
to compare the number of RBC units transfused by group (standard group or optimization group) over a period of 5 days counted from the first decision of transfusion taken post-operative
Secondary Outcome Measures
Full Information
NCT ID
NCT01341002
First Posted
April 21, 2011
Last Updated
May 12, 2015
Sponsor
University Hospital, Lille
1. Study Identification
Unique Protocol Identification Number
NCT01341002
Brief Title
Red Blood Cells (RBC) Transfusion Related to Central Venous O2 Saturation (ScvO2) Measurement
Official Title
Red Blood Cells (RBC) Transfusion Related to Central Venous O2 Saturation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of this study is to estimate red blood cells (RBC) transfusion related to central venous O2 saturation (ScvO2) measurement. This prospective, randomized trial is performed in visceral, vascular and thoracic surgery units in the university hospital of Lille.
One hundred patients need to be included. Inclusion criteria are: age 18 to 99 year old, patient with central venous catheter in place and fulfilling the haemoglobin (Hb) threshold criteria for RBC transfusion according to the XXIIIth French Consensus Conference in critical care medicine recommendations.
After randomisation, patients will be eligible to receive RBC according to their level of Hb in the standard group and according to the Hb and ScvO2 in the optimization group. Patients without any disease are transfused if their Hb level is below 7g/dL; patients older than 60 years or having sepsis are transfused if their Hb level is 8g/dL or lower and cardiac patients are transfused if their Hb level is 9g/dL or lower. In the second group, transfusion is performed if and only if the ScvO2 level is les than 70% when Hb is under the same threshold levels.
The primary aim of the study is to compare the number of RBC units transfused by group (standard group or optimization group) over a period of 5 days counted from the first decision of transfusion taken post-operative. Considering the randomisation and considering the 50 % reduction of the decisions of transfusion in the group optimization, the absolute blood savings is estimated 25 % for the whole population. Secondary end points include the number of side effects associated with transfusion or when avoiding transfusion, length of hospital stay, and hospital mortality as well as major adverse events.
Detailed Description
red blood cells central venous O2 saturation surgery transfusion XXIIIth French Consensus Conference adult
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications, Erythrocyte Transfusion, Oxygen Disorders
Keywords
Postoperative Care, red blood cell transfusion, venous oxygen saturation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SCVO2 < 70%
Arm Type
Experimental
Arm Description
guidelines transfusion + SCVO2 < 70%
Arm Title
currently intervention
Arm Type
Active Comparator
Arm Description
guidelines transfusion
Intervention Type
Procedure
Intervention Name(s)
Transfusion
Intervention Description
Red Blood Cells (RBC) Transfusion if SCVO2 < 70% and guidelines
Intervention Type
Procedure
Intervention Name(s)
Transfusion
Intervention Description
transfusion based on guidelines
Primary Outcome Measure Information:
Title
Number of RBC units transfused by group
Description
to compare the number of RBC units transfused by group (standard group or optimization group) over a period of 5 days counted from the first decision of transfusion taken post-operative
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
central venous catheter
anemia With reference to french consensus about transfusion
Exclusion Criteria:
intensive care
emergency transfusion
shock, hypovolemia
need to go under surgery into 4 hours
acute kidney injury or chronic renal disease
brain injury
pregnancy
heart disease : ischemia <1 mois
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benoît VALLET, PU-PH
Organizational Affiliation
Lille University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
university Hospital, lille
City
Lille
ZIP/Postal Code
59037
Country
France
12. IPD Sharing Statement
Learn more about this trial
Red Blood Cells (RBC) Transfusion Related to Central Venous O2 Saturation (ScvO2) Measurement
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