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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2014-05-31

Brief Summary

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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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Detailed Description

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

Conditions

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Postoperative Complications Erythrocyte Transfusion Oxygen Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SCVO2 < 70%

guidelines transfusion + SCVO2 \< 70%

Group Type EXPERIMENTAL

Transfusion

Intervention Type PROCEDURE

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

currently intervention

guidelines transfusion

Group Type ACTIVE_COMPARATOR

Transfusion

Intervention Type PROCEDURE

transfusion based on guidelines

Interventions

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Transfusion

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

Intervention Type PROCEDURE

Transfusion

transfusion based on guidelines

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No