Red Blood Cells (RBC) Transfusion Related to Central Venous O2 Saturation (ScvO2) Measurement

Study Overview
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Brief Summary
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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
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red blood cells central venous O2 saturation surgery transfusion XXIIIth French Consensus Conference adult

Official Title
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Red Blood Cells (RBC) Transfusion Related to Central Venous O2 Saturation

Conditions
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Postoperative Complications, Erythrocyte Transfusion, Oxygen Disorders

Intervention / Treatment
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* Procedure: Transfusion
* Procedure: Transfusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SCVO2 < 70%<br>guidelines transfusion + SCVO2 < 70% | Procedure: Transfusion<br>* Red Blood Cells (RBC) Transfusion if SCVO2 < 70% and guidelines<br>|
| Active Comparator: currently intervention<br>guidelines transfusion | Procedure: Transfusion<br>* transfusion based on guidelines<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative Care, red blood cell transfusion, venous oxygen saturation