SvO2 Trigger in Transfusion Strategy After Cardiac Surgery

NCT ID: NCT02761564

Last Updated: 2019-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-06
• Study Completion Date: 2018-10-17

Brief 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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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%.

Group Type: EXPERIMENTAL

ScvO2 measure

Intervention Type: OTHER

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%.

Control group

Anemia (\<9g/dL) requiring blood transfusion : Transfusion is performed following national guidelines for red blood cell transfusion

Group Type: OTHER

Red blood cell tranfusion

Intervention Type: OTHER

Red blood cell transfusion according to transfusion guidelines.

Interventions

Red blood cell tranfusion

Red blood cell transfusion according to transfusion guidelines.

Intervention Type: 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%.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Norddine ZEOURAL, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

UHMontpellier

Montpellier, , France

Countries

France

Other Identifiers

9655

Identifier Type: -

Identifier Source: org_study_id