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

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Complications; Erythrocyte Transfusion; Oxygen Disorders
• Intervention / Treatment: Procedure: Transfusion; Procedure: Transfusion

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France, 59037
    • University Hospital, Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SCVO2 < 70%; guidelines transfusion + SCVO2 < 70%	Procedure: Transfusion; Red Blood Cells (RBC) Transfusion if SCVO2 < 70% and guidelines; Procedure: Transfusion; transfusion based on guidelines
Active Comparator: currently intervention; guidelines transfusion	Procedure: Transfusion; Red Blood Cells (RBC) Transfusion if SCVO2 < 70% and guidelines; Procedure: Transfusion; transfusion based on guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of RBC units transfused by group	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	5 days

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Benoît VALLET, PU-PH, Lille University Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: April 21, 2011
• First Submitted That Met QC Criteria: April 22, 2011
• First Posted (Estimate): April 25, 2011

Study Record Updates

• Last Update Posted (Estimate): May 13, 2015
• Last Update Submitted That Met QC Criteria: May 12, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Postoperative Care; red blood cell transfusion; venous oxygen saturation
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: 2008-A01247-48; 2008/0834 (Other Identifier: sponsor); B81159-60 (Other Identifier: AFSSAPS)