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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01341002
Enrollment
100
Registered
2011-04-25
Start date
2009-11-30
Completion date
2014-05-31
Last updated
2015-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erythrocyte Transfusion, Oxygen Disorders, Postoperative Complications

Keywords

Postoperative Care, red blood cell transfusion, venous oxygen saturation

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

Interventions

PROCEDURETransfusion

Red Blood Cells (RBC) Transfusion if SCVO2 \< 70% and guidelines

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of RBC units transfused by group5 daysto 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026