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CompletedNCT03346512Updated Apr 19, 2019

Considerations on the Transfusion Threshold in Cardiac Surgery

An observational study in Cardiac Surgery, sponsored by Pierre Wauthy. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-19.

Sponsored by Pierre Wauthy · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
852
Ages
18 Years and older
Sex
All
01

Study summary

This is a retrospective observational study of the transfusion threshold in cardiac surgery.

There is controversy in the literature regarding the transfusion threshold to be adopted, especially in a patient who has undergone cardiac surgery. Some authors suggest that the transfusion should be done in a restrictive way when a certain threshold in hemoglobin is reached, in order to avoid the risks it implies, especially infectious.This threshold is very controversial and remains to be defined (variations in the literature from 7g / dL to 9g / dL). Other authors conclude that there is no superiority of a restrictive transfusion compared to a more liberal transfusion, with regard to the morbidity or medical costs.

It is therefore interesting to study, in a retrospective manner, the global and multidisciplinary management of patients who have undergone a cardiac surgery within the CHU Brugmann hospital, to analyze if they have been adequately transfused.

02

Conditions studied

  • Cardiac Surgery
03

In context

Lead sponsor

Pierre Wauthy is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients having undergone cardiac surgery (other than the placement of a pacemaker or defibrillator) within the CHU Brugmann hospital between 2006 and 2015

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients having undergone cardiac surgery (other than the placement of a pacemaker or defibrillator) within the CHU Brugmann hospital between 2006 and 2015

Exclusion criteria

Exclusion Criteria:

  • N/A
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
852 participants (actual)
Patient registry
No

Groups and cohorts

  • Cardiac surgery

    Patients having undergone cardiac surgery (other than the placement of a pacemaker or defibrillator) within the CHU Brugmann hospital between 2006 and 2015

    Procedure: Cardiac surgery

Interventions

  • ProcedureCardiac surgery

    Cardiac surgery

06

What researchers measure

Primary outcomes

  1. Hemoglobin rate

    Hemoglobin rate

    Time frame: Baseline (just before cardiac surgery)

  2. Hemoglobin rate

    Hemoglobin rate

    Time frame: One day after surgery (J1)

  3. Hemoglobin rate

    Hemoglobin rate

    Time frame: Two days after surgery (J2)

  4. Hemoglobin rate

    Hemoglobin rate

    Time frame: Five days after surgery (J5)

  5. Hematocrit rate

    Hematocrit rate

    Time frame: Baseline (just before cardiac surgery)

  6. Hematocrit rate

    Hematocrit rate

    Time frame: One day after surgery (J1)

  7. Hematocrit rate

    Hematocrit rate

    Time frame: Two days after surgery (J2)

  8. Hematocrit rate

    Hematocrit rate

    Time frame: Five days after surgery (J5)

  9. International Normalized Ratio (INR)

    Coagulation indicator

    Time frame: Baseline (just before cardiac surgery)

  10. International Normalized Ratio (INR)

    Coagulation indicator

    Time frame: One day after surgery (J1)

  11. International Normalized Ratio (INR)

    Coagulation indicator

    Time frame: Two days after surgery (J2)

  12. International Normalized Ratio (INR)

    Coagulation indicator

    Time frame: Five days after surgery (J5)

  13. Creatinin rate

    Renal function indicator

    Time frame: Baseline (just before cardiac surgery)

  14. Creatinin rate

    Renal function indicator

    Time frame: One day after surgery (J1)

  15. Creatinin rate

    Renal function indicator

    Time frame: Two days after surgery (J2)

  16. Creatinin rate

    Renal function indicator

    Time frame: Five days after surgery (J5)

  17. Total amount of blood perfusions

    Total amount of blood perfusions

    Time frame: Five days after surgery (J5)

  18. Liquid balance

    Ratio between total fluid intake (perfusion) and loss (blood and urine)

    Time frame: One day after surgery

07

Study locations

1 site
  • CHU Brugmann
    Brussels, 1020, Belgium
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2016 to primary completion in Jun 2016, 4 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 15, 2017
First posted
Nov 17, 2017
StartActual
Feb 2016
Primary completionActual
Jun 14, 2016
CompletionActual
Jun 14, 2016
Last update
Apr 19, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03346512
Lead sponsor
Pierre Wauthy
Responsible party
Pierre Wauthy (Head of clinic, Brugmann University Hospital) — Sponsor-investigator
First posted
Nov 17, 2017
Start date
Feb 2016
Primary completion
Jun 14, 2016
Completion
Jun 14, 2016
Last update
Apr 19, 2019

Study contacts

Kenza Bradly, MD
principal investigator · CHU Brugmann

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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