NCT03346512

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
852

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

February 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2016

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
Last Updated

April 19, 2019

Status Verified

April 1, 2019

Enrollment Period

4 months

First QC Date

November 15, 2017

Last Update Submit

April 18, 2019

Conditions

Cardiac Surgery

Outcome Measures

Primary Outcomes (18)

  • 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

Study Arms (1)

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

Cardiac surgeryPROCEDURE

Cardiac surgery

Cardiac surgery

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

MeSH Terms

Interventions

Cardiac Surgical Procedures

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Officials

  • Kenza Bradly, MD

    CHU Brugmann

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of clinic

Study Record Dates

First Submitted

November 15, 2017

First Posted

November 17, 2017

Study Start

February 1, 2016

Primary Completion

June 14, 2016

Study Completion

June 14, 2016

Last Updated

April 19, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)