Cardiac Surgery Outcomes in Blood-transfusion Acceptors and no Acceptors

Cardiac Disease Clinical Trial

Official title:

Cardiac Surgery Outcomes in Blood-transfusion Acceptors and no Acceptors: a Retrospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04609228
• Other study ID #: IIBSP-TRA-2020-36
• Status: Recruiting
• Start date: October 30, 2020
• Est. completion date: October 1, 2022

Study information

• Verified date: March 2022
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Elena Roselló-Díez, MD, PhD
• Phone: +34 935565957
• Email: erosello[@]santpau.cat
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary objective of this study is to analyze mortality after cardiac surgery in blood-transfusion non-acceptors (BTNA), and the secondary one to perform an adjusted comparison with a blood-transfusion acceptors (BTA) matched cohort.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1911
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Patients undergoing heart surgery in our hospital from 2009 to June 2020

Exclusion Criteria:

• Preoperative hemoglobin lower than 120g/L
• EuroSCORE-II higher than 20%
• Heart transplant
• Assist device implantation
• Surgery of acute myocardial infarction-derived complications
• Other emergent cardiac surgeries (acute aortic dissection, heart injuries).

Related Conditions & MeSH terms

• Blood Transfusion; Hemoglobinemia
• Cardiac Disease
• Heart Diseases
• Thoracic Surgery

Intervention

Other:
• Non-acceptance of blood-transfusions
Patients who do not accept blood products transfusions
• Acceptance of blood-transfusions
Patients who accept blood products transfusions

Locations

Country	Name	City	State
Spain	Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change on Hemoglobin values from preoperative to end-of-surgery levels	Changes on Hemoglobin values in percentage from preoperative level to the end of the surgery level	End-of-surgery
Secondary	Rate of operative mortality	Any death occurring i) within the first 30 postoperative days in or out of the hospital, and ii) after 30 days during the same hospitalization subsequent to the operation.	At discharge or within the first 30 postoperative days
Secondary	Intraoperative fluid balance	Resting the fluid outputs to inputs	End of surgery
Secondary	Hemoglobin at discharge	Hemoglobin level at discharge	At discharge, an average of 10 days
Secondary	Rate of postoperative morbidity	Postoperative complications: hemodynamic, respiratory, renal, neurological, infective complications	At discharge, an average of 10 days