Clinical trial NCT01341002: 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
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Complications
Erythrocyte Transfusion
Oxygen Disorders
Keywords: Postoperative Care
red blood cell transfusion
venous oxygen saturation
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2011-04-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Number of RBC units transfused by group
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: university Hospital, lille
Study officials:
affiliation: Lille University Hospital
name: Benoît VALLET, PU-PH
role: PRINCIPAL_INVESTIGATOR
References: