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

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01341002
• Other study ID #: 2008-A01247-48
• Secondary ID: 2008/0834B81159-
• Status: Completed
• Phase: N/A
• First received: April 21, 2011
• Last updated: May 12, 2015
• Start date: November 2009
• Est. completion date: May 2014

Study information

• Verified date: May 2015
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erythrocyte Transfusion
• Oxygen Disorders
• Postoperative Complications

Intervention

Procedure:
• Transfusion
Red Blood Cells (RBC) Transfusion if SCVO2 < 70% and guidelines
• Transfusion
transfusion based on guidelines

Locations

Country	Name	City	State
France	university Hospital, lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No