SvO2 Trigger in Transfusion Strategy After Cardiac Surgery (ReTSEACS)
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|ClinicalTrials.gov Identifier: NCT02761564|
Recruitment Status : Recruiting
First Posted : May 4, 2016
Last Update Posted : March 29, 2018
Current international guidelines suggest a restrictive transfusion strategy, setting that Hb level at 7 g/dl is a reasonable threshold. However, the idea of having only one threshold for all the patients has been challenged by authors, suggesting a more liberal strategy for certain cases. At the moment, there is no other parameter considered accurate enough to be taken into consideration for transfusion strategy management.
This study is to use ScVO2, a current, easily accessible parameter, before blood transfusion in order to stratify its indication after cardiac surgery.
Monocentric, randomised, single blind study (patient not aware of the group assignments) Patient inclusion will be made in ICU if the physician decides to perform blood transfusion according to standard transfusion strategy to treat a postoperative anemia (Hb<9g/dL).
Every patient will go through randomization to be placed in one of the two groups of the study: either the one whose transfusion strategy is adjusted by the pretransfusion ScvO2 (group ScvO2), or the control group.
Our main objective is to evaluate the impact of a new transfusion strategy founded on guidelines, but provided ScvO2 is less than 65%, on the incidence of red blood cells transfusion for anemia early after cardiac surgery.
|Condition or disease||Intervention/treatment||Phase|
|Undergoing Nonemergent Cardiac Surgery Central Venous Catheter on the Superior Vena Cava (to Perform ScVO2 Measure) Anemia (<9g/dL) Requiring Blood Transfusion Hemodynamic and Respiratory Stability Bleeding Graded as Insignificant, Mild, Moderate of Universal Definition of Perioperative Bleeding||Other: Red blood cell tranfusion Other: ScvO2 measure||Not Applicable|
Currently, the rate of transfusion of cardiac surgery patients is approximately 50%. The decision to transfuse is based on the hemoglobin (Hb), the transfusion threshold from 7 to 9 g / dL seems to be reasonable, based on clinical parameters, as well as patient history, as the degree of coronary stenosis . Several randomized studies have shown that a restrictive transfusion strategy was superior to a liberal strategy.
ScvO2 is a parameter reflecting the balance between transport O2 and O2 in tissue consumption, which Hb is one of the determinants. It requires that a levy on central venous used frequently for such patients. ScvO2 could make better account of the actual tolerance of anemia that the only value of Hb and the patient's clinical characteristics.
We therefore hypothesize that ScvO2 can help with the decision of RBC transfusions after heart surgery.
Primary and secondary endpoints Principal: To assess the value of ScvO2 threshold (65%) in the restrictive transfusion strategy on the incidence of transfusion after cardiac surgery.
- Assess the impact of transfusion strategy based on ScvO2 on the number of transfused patients at D28
- Assess the impact of transfusion strategy based on ScvO2 on the number of cells transfused concentrates.
- Assess the impact of transfusion strategy based on ScvO2 on mortality or incidence of disease events such as cardiac complications, renal, respiratory or neurological dysfunction in the immediate aftermath of surgery.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Restrictive Transfusion Strategy Early After Cardiac Surgery|
|Actual Study Start Date :||October 6, 2016|
|Actual Primary Completion Date :||November 25, 2016|
|Estimated Study Completion Date :||October 30, 2018|
Experimental: ScVO2 group
Anemia (<9g/dL) requiring blood transfusion Measure of ScvO2 : ScVO2 is measured using the central venous catheter placed in the superior vena cava. Transfusion is performed if the ScVO2 is inferior or equal to 65%.
Other: ScvO2 measure
ScvO2 (oximetry) is measured at the distal lumen of the central venous catheter placed in the superior vena cava. Transfusion is performed if ScvO2 is inferior or equal to 65%.
Anemia (<9g/dL) requiring blood transfusion : Transfusion is performed following national guidelines for red blood cell transfusion
Other: Red blood cell tranfusion
Red blood cell transfusion according to transfusion guidelines.
- Number of patients transfused [ Time Frame: Between 1 and 28 days (ICU stay) ]Number of patients transfused during ICU stay
- Number of patients transfused [ Time Frame: Day 28 ]Number of patients transfused on day 28
- Number of blood units transfused in ICU [ Time Frame: Between 1 and 28 days (ICU stay) ]Number of blood units transfused during ICU stay
- Number of blood units transfused on day 28 [ Time Frame: Day 28 ]Number of blood units transfused
- Incidence of mortality [ Time Frame: Day 28 ]Incidence of 28-day mortality
- total duration of mechanical ventilation [ Time Frame: Day 1 to 28 ]total duration of mechanical ventilation on D28
- length of stay in ICU [ Time Frame: Day 1 to 28 ]The length of stay in ICU
- length of hospital stay [ Time Frame: Between 1 and 28 days ]The length of stay during hospitalization (Between 1 and 28 days)
- Organ failure incidence [ Time Frame: Day 1 to 28 ]incidence of organ failure at day 28
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02761564
|Contact: Norddine ZEROUAL, MD||0467336059 ext email@example.com|
|Contact: Pascal COLSON, MD||0467335937 ext 33|
|Contact: Norddine ZEROUAL, MD 0467336059 ext 33|
|Contact: Pascal COLSON, MD 0467335957 ext 33|
|Sub-Investigator: GIANLUCA SAMARANI, MD, PhD|
|Principal Investigator:||Norddine ZEOURAL, MD||University Hospital, Montpellier|