SvO2 Trigger in Transfusion Strategy After Cardiac Surgery

Anemia (<9g/dL) Requiring Blood Transfusion Clinical Trial

— ReTSEACS  

Official title:

Restrictive Transfusion Strategy Early After Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02761564
• Other study ID #: 9655
• Status: Completed
• Phase: N/A
• Start date: October 6, 2016
• Est. completion date: October 17, 2018

Study information

• Verified date: May 2016
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

secondary:

• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 17, 2018
• Est. primary completion date: September 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Age over 18 years

• Patients admitted to intensive care after heart surgery

• Anemic patient (Hb < 9 g/dL)

• Patient with a central venous catheter in the territory SVC

Exclusion Criteria:

• Patient with acute bleeding defined as a postoperative bleeding over 1000 ml in 12 hours or the need for a recovery operation for hemostasis or the transfusion of blood units over 4

• Patient with severe sepsis or septic shock criteria defined by the Surviving Sepsis compaign

Related Conditions & MeSH terms

• Anemia (<9g/dL) Requiring Blood Transfusion
• Bleeding Graded as Insignificant, Mild, Moderate of Universal Definition of Perioperative Bleeding
• Central Venous Catheter on the Superior Vena Cava (to Perform ScVO2 Measure)
• Hemodynamic and Respiratory Stability
• Hemorrhage
• Undergoing Nonemergent Cardiac Surgery

Intervention

Other:
• Red blood cell tranfusion
Red blood cell transfusion according to transfusion guidelines.
• 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%.

Locations

Country	Name	City	State
France	UHMontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of mortality	Incidence of 28-day mortality	Day 28
Other	total duration of mechanical ventilation	total duration of mechanical ventilation on D28	Day 1 to 28
Other	length of stay in ICU	The length of stay in ICU	Day 1 to 28
Other	length of hospital stay	The length of stay during hospitalization (Between 1 and 28 days)	Between 1 and 28 days
Other	Organ failure incidence	incidence of organ failure at day 28	Day 1 to 28
Primary	Number of patients transfused	Number of patients transfused during ICU stay	Between 1 and 28 days (ICU stay)
Secondary	Number of patients transfused	Number of patients transfused on day 28	Day 28
Secondary	Number of blood units transfused in ICU	Number of blood units transfused during ICU stay	Between 1 and 28 days (ICU stay)
Secondary	Number of blood units transfused on day 28	Number of blood units transfused	Day 28