Considerations on the Transfusion Threshold in Cardiac Surgery

April 18, 2019 updated by: Pierre Wauthy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

852

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1020
        • CHU Brugmann

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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:

  • N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Cardiac surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin rate
Time Frame: Baseline (just before cardiac surgery)
Hemoglobin rate
Baseline (just before cardiac surgery)
Hemoglobin rate
Time Frame: One day after surgery (J1)
Hemoglobin rate
One day after surgery (J1)
Hemoglobin rate
Time Frame: Two days after surgery (J2)
Hemoglobin rate
Two days after surgery (J2)
Hemoglobin rate
Time Frame: Five days after surgery (J5)
Hemoglobin rate
Five days after surgery (J5)
Hematocrit rate
Time Frame: Baseline (just before cardiac surgery)
Hematocrit rate
Baseline (just before cardiac surgery)
Hematocrit rate
Time Frame: One day after surgery (J1)
Hematocrit rate
One day after surgery (J1)
Hematocrit rate
Time Frame: Two days after surgery (J2)
Hematocrit rate
Two days after surgery (J2)
Hematocrit rate
Time Frame: Five days after surgery (J5)
Hematocrit rate
Five days after surgery (J5)
International Normalized Ratio (INR)
Time Frame: Baseline (just before cardiac surgery)
Coagulation indicator
Baseline (just before cardiac surgery)
International Normalized Ratio (INR)
Time Frame: One day after surgery (J1)
Coagulation indicator
One day after surgery (J1)
International Normalized Ratio (INR)
Time Frame: Two days after surgery (J2)
Coagulation indicator
Two days after surgery (J2)
International Normalized Ratio (INR)
Time Frame: Five days after surgery (J5)
Coagulation indicator
Five days after surgery (J5)
Creatinin rate
Time Frame: Baseline (just before cardiac surgery)
Renal function indicator
Baseline (just before cardiac surgery)
Creatinin rate
Time Frame: One day after surgery (J1)
Renal function indicator
One day after surgery (J1)
Creatinin rate
Time Frame: Two days after surgery (J2)
Renal function indicator
Two days after surgery (J2)
Creatinin rate
Time Frame: Five days after surgery (J5)
Renal function indicator
Five days after surgery (J5)
Total amount of blood perfusions
Time Frame: Five days after surgery (J5)
Total amount of blood perfusions
Five days after surgery (J5)
Liquid balance
Time Frame: One day after surgery
Ratio between total fluid intake (perfusion) and loss (blood and urine)
One day after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pierre Wauthy

Investigators

  • Principal Investigator: Kenza Bradly, MD, CHU Brugmann

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

June 14, 2016

Study Completion (Actual)

June 14, 2016

Study Registration Dates

First Submitted

November 15, 2017

First Submitted That Met QC Criteria

November 15, 2017

First Posted (Actual)

November 17, 2017

Study Record Updates

Last Update Posted (Actual)

April 19, 2019

Last Update Submitted That Met QC Criteria

April 18, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • CHUB-perfusion

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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