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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by University Hospital, Lille.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT01341002
First received: April 21, 2011
Last updated: April 22, 2011
Last verified: August 2010
  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

Resource links provided by NLM:


Further study details as provided by University Hospital, Lille:

Primary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01341002

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   
Sponsors and Collaborators
University Hospital, Lille
Investigators
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 July 28, 2014