Cardiac Surgery Outcomes in Blood-transfusion Acceptors and no Acceptors

• Conditions: Thoracic Surgery; Blood Transfusion; Hemoglobinemia; Cardiac Disease
• Interventions: Other: Acceptance of blood-transfusions; Other: Non-acceptance of blood-transfusions

• Registration Number: NCT04609228
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-15
• Study First Submitted QC: 2020-10-29
• Study Start: 2020-10-30
• Study First Posted: 2020-10-30
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-15
• Last Update Posted: 2022-03-16
• Primary Completion: 2022-10-01
• Study Completion: 2022-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1911

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Blood-transfusion acceptors	Acceptance of blood-transfusions	Blood-transfusion acceptors
Blood-transfusion non-acceptors	Non-acceptance of blood-transfusions	Blood-transfusion non-acceptors

Primary Outcome Measures

Name	Time	Method
Change on Hemoglobin values from preoperative to end-of-surgery levels	End-of-surgery	Changes on Hemoglobin values in percentage from preoperative level to the end of the surgery level

Secondary Outcome Measures

Name	Time	Method
Hemoglobin at discharge	At discharge, an average of 10 days	Hemoglobin level at discharge
Intraoperative fluid balance	End of surgery	Resting the fluid outputs to inputs
Rate of postoperative morbidity	At discharge, an average of 10 days	Postoperative complications: hemodynamic, respiratory, renal, neurological, infective complications
Rate of operative mortality	At discharge or within the first 30 postoperative days	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.

Trial Locations

Locations (1)

Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain