Red Blood Cells (RBC) Transfusion Related to Central Venous O2 Saturation (ScvO2) Measurement
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Postoperative Complications Red Blood Cell Transfusion Oxygen Disorders |
Procedure: Transfusion |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Red Blood Cells (RBC) Transfusion Related to Central Venous O2 Saturation |
- Number of RBC units transfused by group [ Time Frame: 5 days ] [ Designated as safety issue: No ]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
| Estimated Enrollment: | 100 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | November 2011 |
| Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: SCVO2 < 70%
guidelines transfusion + SCVO2 < 70%
|
Procedure: Transfusion
Red Blood Cells (RBC) Transfusion if SCVO2 < 70% and guidelines
|
|
Active Comparator: currently intervention
guidelines transfusion
|
Procedure: Transfusion
transfusion based on guidelines
|
Detailed Description:
red blood cells central venous O2 saturation surgery transfusion XXIIIth French Consensus Conference adult
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| France | |
| university Hospital, lille | Recruiting |
| Lille, France, 59037 | |
| Contact: Benoît VALLET, Pr +33.3.20.44.51.97 bvallet@chru-lille.fr | |
| Contact: Olivier BARREAU, Dr +33.3.20.44.51.97 olivier.barreau@chru-lille.fr | |
| Principal Investigator: | Benoît VALLET, PU-PH | Lille University Hospital |
More Information
No publications provided
| Responsible Party: | Pr B Vallet, University Hospital, Lille |
| ClinicalTrials.gov Identifier: | NCT01341002 History of Changes |
| Other Study ID Numbers: | 2008-A01247-48, 2008/0834, B81159-60 |
| Study First Received: | April 21, 2011 |
| Last Updated: | April 22, 2011 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by University Hospital, Lille:
|
Postoperative Care red blood cell transfusion venous oxygen saturation |
Additional relevant MeSH terms:
|
Postoperative Complications Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013