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SvO2 Trigger in Transfusion Strategy After Cardiac Surgery

NCT02761564 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-03-22

No results posted yet for this study

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

Interventions

OTHER

Red blood cell tranfusion

Red blood cell transfusion according to transfusion guidelines.

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%.

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Norddine ZEOURAL, MD · University Hospital, Montpellier

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-06
Primary Completion
2018-09-17
Completion
2018-10-17

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02761564 on ClinicalTrials.gov