Postoperative Complications Clinical Trial
Official title:
Red Blood Cells (RBC) Transfusion Related to Central Venous O2 Saturation
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.
red blood cells central venous O2 saturation surgery transfusion XXIIIth French Consensus Conference adult ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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