Considerations on the Transfusion Threshold in Cardiac Surgery

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: Cardiac Surgery
• Intervention / Treatment: Procedure: Cardiac surgery

• Study Type: Observational
• Enrollment (Actual): 852

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1020
    • CHU Brugmann

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

1

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

Collaborators and Investigators

• Sponsor: Pierre Wauthy
• Investigators: Principal Investigator: Kenza Bradly, MD, CHU Brugmann

Study record dates

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