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SvO2 Trigger in Transfusion Strategy After Cardiac Surgery (ReTSEACS)

Primary Purpose

Undergoing Nonemergent Cardiac Surgery, Central Venous Catheter on the Superior Vena Cava (to Perform ScVO2 Measure), Anemia (<9g/dL) Requiring Blood Transfusion

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Red blood cell tranfusion
ScvO2 measure
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Undergoing Nonemergent Cardiac Surgery focused on measuring Cardiac surgery, Blood transfusion, ScvO2

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UHMontpellier

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

ScVO2 group

Control group

Arm Description

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%.

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

Outcomes

Primary Outcome Measures

Number of patients transfused
Number of patients transfused during ICU stay

Secondary Outcome Measures

Number of patients transfused
Number of patients transfused on day 28
Number of blood units transfused in ICU
Number of blood units transfused during ICU stay
Number of blood units transfused on day 28
Number of blood units transfused

Full Information

First Posted
April 28, 2016
Last Updated
March 20, 2019
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT02761564
Brief Title
SvO2 Trigger in Transfusion Strategy After Cardiac Surgery
Acronym
ReTSEACS
Official Title
Restrictive Transfusion Strategy Early After Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
October 6, 2016 (Actual)
Primary Completion Date
September 17, 2018 (Actual)
Study Completion Date
October 17, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
Cardiac surgery, Blood transfusion, ScvO2

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ScVO2 group
Arm Type
Experimental
Arm Description
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%.
Arm Title
Control group
Arm Type
Other
Arm Description
Anemia (<9g/dL) requiring blood transfusion : Transfusion is performed following national guidelines for red blood cell transfusion
Intervention Type
Other
Intervention Name(s)
Red blood cell tranfusion
Intervention Description
Red blood cell transfusion according to transfusion guidelines.
Intervention Type
Other
Intervention Name(s)
ScvO2 measure
Intervention Description
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%.
Primary Outcome Measure Information:
Title
Number of patients transfused
Description
Number of patients transfused during ICU stay
Time Frame
Between 1 and 28 days (ICU stay)
Secondary Outcome Measure Information:
Title
Number of patients transfused
Description
Number of patients transfused on day 28
Time Frame
Day 28
Title
Number of blood units transfused in ICU
Description
Number of blood units transfused during ICU stay
Time Frame
Between 1 and 28 days (ICU stay)
Title
Number of blood units transfused on day 28
Description
Number of blood units transfused
Time Frame
Day 28
Other Pre-specified Outcome Measures:
Title
Incidence of mortality
Description
Incidence of 28-day mortality
Time Frame
Day 28
Title
total duration of mechanical ventilation
Description
total duration of mechanical ventilation on D28
Time Frame
Day 1 to 28
Title
length of stay in ICU
Description
The length of stay in ICU
Time Frame
Day 1 to 28
Title
length of hospital stay
Description
The length of stay during hospitalization (Between 1 and 28 days)
Time Frame
Between 1 and 28 days
Title
Organ failure incidence
Description
incidence of organ failure at day 28
Time Frame
Day 1 to 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norddine ZEOURAL, MD
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
UHMontpellier
City
Montpellier
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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SvO2 Trigger in Transfusion Strategy After Cardiac Surgery

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