SvO2 Trigger in Transfusion Strategy After Cardiac Surgery

NCT02761564 | Completed

• 1 other identifier: 9655
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

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

Keywords

Cardiac surgery; Blood transfusion; ScvO2

Outcome Measures

Primary Outcomes (1)

• Number of patients transfused

  Number of patients transfused during ICU stay

  Between 1 and 28 days (ICU stay)

Secondary Outcomes (3)

• Number of patients transfused

  Day 28

• Number of blood units transfused in ICU

  Between 1 and 28 days (ICU stay)

• Number of blood units transfused on day 28

  Day 28

Other Outcomes (5)

• Incidence of mortality

  Day 28

• total duration of mechanical ventilation

  Day 1 to 28

• length of stay in ICU

  Day 1 to 28

Study Arms (2)

ScVO2 group

EXPERIMENTAL

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

Control group

OTHER

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

Other: Red blood cell tranfusion

Interventions

Red blood cell tranfusion OTHER

Red blood cell transfusion according to transfusion guidelines.

Control group

ScvO2 measure 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%.

ScVO2 group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

UHMontpellier

Montpellier, Montpellier, France

Location

Related Publications (1)

• Zeroual N, Blin C, Saour M, David H, Aouinti S, Picot MC, Colson PH, Gaudard P. Restrictive Transfusion Strategy after Cardiac Surgery. Anesthesiology. 2021 Mar 1;134(3):370-380. doi: 10.1097/ALN.0000000000003682.

  PMID: 33475735 RESULT

MeSH Terms

Conditions

Anemia; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Norddine ZEOURAL, MD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2016
• First Posted: May 4, 2016
• Study Start: October 6, 2016
• Primary Completion: September 17, 2018
• Study Completion: October 17, 2018
• Last Updated: June 12, 2026

Record last verified: 2016-05

Locations

FR (1)