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NCT Number: NCT01341002

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

university Hospital, lille

Lille, 59037, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transfusion

Procedure

Red Blood Cells (RBC) Transfusion if SCVO2 < 70% and guidelines

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2013
Study completion
2014
First posted
Apr 25, 2011
Registry last updated
May 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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