Considerations on the Transfusion Threshold in Cardiac Surgery

Cardiac Surgery Clinical Trial

Official title:

Considerations on the Transfusion Threshold in Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03346512
• Other study ID #: CHUB-perfusion
• Status: Completed
• Start date: February 2016
• Est. completion date: June 14, 2016

Study information

• Verified date: April 2019
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 852
• Est. completion date: June 14, 2016
• Est. primary completion date: June 14, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

Procedure:
• Cardiac surgery
Cardiac surgery

Locations

Country	Name	City	State
Belgium	CHU Brugmann	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Pierre Wauthy

Country where clinical trial is conducted

Belgium, 

Outcome

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