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SvO2 Trigger in Transfusion Strategy After Cardiac Surgery (ReTSEACS)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2016 by University Hospital, Montpellier
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT02761564
First received: April 28, 2016
Last updated: May 18, 2016
Last verified: May 2016
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Restrictive Transfusion Strategy Early After Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • Number of patients transfused [ Time Frame: Between 1 and 28 days (ICU stay) ] [ Designated as safety issue: No ]
    Number of patients transfused during ICU stay


Secondary Outcome Measures:
  • Number of patients transfused [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
    Number of patients transfused on day 28

  • Number of blood units transfused in ICU [ Time Frame: Between 1 and 28 days (ICU stay) ] [ Designated as safety issue: No ]
    Number of blood units transfused during ICU stay

  • Number of blood units transfused on day 28 [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
    Number of blood units transfused


Other Outcome Measures:
  • Incidence of mortality [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
    Incidence of 28-day mortality

  • total duration of mechanical ventilation [ Time Frame: Day 1 to 28 ] [ Designated as safety issue: No ]
    total duration of mechanical ventilation on D28

  • length of stay in ICU [ Time Frame: Day 1 to 28 ] [ Designated as safety issue: No ]
    The length of stay in ICU

  • length of hospital stay [ Time Frame: Between 1 and 28 days ] [ Designated as safety issue: No ]
    The length of stay during hospitalization (Between 1 and 28 days)

  • Organ failure incidence [ Time Frame: Day 1 to 28 ] [ Designated as safety issue: No ]
    incidence of organ failure at day 28


Estimated Enrollment: 100
Study Start Date: September 2016
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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%.
Control group
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02761564

Contacts
Contact: Norddine ZEROUAL, MD 0467336059 ext 33 n-zeroual@chu-montpellier.fr
Contact: Pascal COLSON, MD 0467335937 ext 33

Locations
France
UHMontpellier
Montpellier, France
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Principal Investigator: Norddine ZEOURAL, MD University Hospital, Montpellier
  More Information

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02761564     History of Changes
Other Study ID Numbers: 9655 
Study First Received: April 28, 2016
Last Updated: May 18, 2016
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by University Hospital, Montpellier:
Cardiac surgery
Blood transfusion
ScvO2

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2016