NCT02963883

Brief Summary

Postoperative erythrocytes transfusion is associated with morbidity and excess mortality, which should lead to ask the indication for RBC transfusions only on metabolic needs. Currently, the majority of studies used to put hemoglobin values indicating red cell transfusions. Two observational studies have confirmed that a transfusion strategy based on a metabolic index (ScvO2) individual was accompanied by a different transfusion strategy than using the hemoglobin threshold values. We propose to conduct the first randomized multicenter study to evaluate erythrocyte transfusion strategy in postoperative cardiac surgery using the ScvO2 each patient versus a threshold value usually recommended for all patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 15, 2016

Completed
16 days until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2020

Completed
Last Updated

September 22, 2025

Status Verified

September 1, 2025

Enrollment Period

3.5 years

First QC Date

November 10, 2016

Last Update Submit

September 17, 2025

Conditions

Cardiac Surgery

Keywords

ScVO2Post operative red cell transfusion

Outcome Measures

Primary Outcomes (1)

  • Number of patients transfused

    Number of patients transfused at least one red blood cell concentrate in postoperative cardiac surgery for the ScvO2 group compared to the control group

    15 dys

Secondary Outcomes (19)

  • acute pulmonary edema due to the overload

    15 days

  • lesional pulmonary edema or TRALI,

    6 h

  • myocardial infarction

    15 days

  • stroke

    15 days

  • acute renal failure,

    15 days

  • +14 more secondary outcomes

Study Arms (2)

SVO2 group

EXPERIMENTAL

After optimization of oxygenation and blood volume, concentrate transfusion (s) of red blood cells by the individual value of ScvO2, whose value must be greater than 70% after elimination of hypovolemia, hypotension or hypoxemia.

Other: SVO2 group / control group

control group

ACTIVE COMPARATOR

After optimization of oxygenation and blood volume, concentrate transfusion (s) of red blood cells based on the hemoglobin values, as recommended by the National Health Authority for Anesthesiology, Surgery, Emergency (November 2014 ): transfusion threshold of \<9 g / dl for patients with cardiovascular antecedents.

Other: SVO2 group / control group

Interventions

SVO2 group / control groupOTHER
SVO2 groupcontrol group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient ≥ 18 years
  • programmed cardiac surgery
  • Central venous catheter placed in territory SVC
  • Affiliation to a social security system
  • Hemoglobin \<9 g / dL (transfusion threshold retained by the recommendations the HAS in November 2014 for perioperative patients with cardiovascular antecedents)

You may not qualify if:

  • Patient minor or under court protection
  • Pregnant or lactating women
  • severe acute hemorrhagic syndrome (defined by bleeding rate greater than 1.5 ml / kg / hour for 6 consecutive hours and / or surgical revision within the first 24 postoperative hours)
  • Installation of an external or internal circulatory support
  • emergency surgery (\<24 hours from admission)
  • Complex Aortic Surgery
  • Sepsis
  • Patient Refusal of transfusion (religious belief)
  • Patient under guardianship
  • Renal failure with dialysis treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Amiens Picardie

Amiens, 80054, France

Location

Caen

Caen, France

Location

Related Publications (1)

  • Fischer MO, Guinot PG, Debroczi S, Huette P, Beyls C, Babatasi G, Bafi K, Guilbart M, Caus T, Lorne E, Dupont H, Hanouz JL, Diouf M, Abou-Arab O. Individualised or liberal red blood cell transfusion after cardiac surgery: a randomised controlled trial. Br J Anaesth. 2022 Jan;128(1):37-44. doi: 10.1016/j.bja.2021.09.037. Epub 2021 Nov 30.

    PMID: 34862002RESULT

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Osama Abou Arab, Doctor

    CHU Amiens-Picardie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2016

First Posted

November 15, 2016

Study Start

December 1, 2016

Primary Completion

May 28, 2020

Study Completion

May 28, 2020

Last Updated

September 22, 2025

Record last verified: 2025-09

Locations

FR(2)