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

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ClinicalTrials.gov Identifier: NCT01341002
Recruitment Status : Completed
First Posted : April 25, 2011
Last Update Posted : May 13, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

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.


Condition or disease Intervention/treatment
Postoperative Complications Erythrocyte Transfusion Oxygen Disorders Procedure: Transfusion

Detailed Description:
red blood cells central venous O2 saturation surgery transfusion XXIIIth French Consensus Conference adult

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Red Blood Cells (RBC) Transfusion Related to Central Venous O2 Saturation
Study Start Date : November 2009
Primary Completion Date : November 2013
Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Number of RBC units transfused by group [ Time Frame: 5 days ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01341002


Locations
France
university Hospital, lille
Lille, France, 59037
Sponsors and Collaborators
University Hospital, Lille
Investigators
Principal Investigator: Benoît VALLET, PU-PH Lille University Hospital

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT01341002     History of Changes
Other Study ID Numbers: 2008-A01247-48
2008/0834 ( Other Identifier: sponsor )
B81159-60 ( Other Identifier: AFSSAPS )
First Posted: April 25, 2011    Key Record Dates
Last Update Posted: May 13, 2015
Last Verified: May 2015

Keywords provided by University Hospital, Lille:
Postoperative Care
red blood cell transfusion
venous oxygen saturation

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes