Cardiac Surgery Outcomes in Blood-transfusion Acceptors and no Acceptors
Overview
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.
Full Title of Study: “Cardiac Surgery Outcomes in Blood-transfusion Acceptors and no Acceptors: a Retrospective Cohort Study”
Study Type
- Study Type: Observational
- Study Design
- Time Perspective: Retrospective
- Study Primary Completion Date: October 1, 2022
Interventions
- Other: Non-acceptance of blood-transfusions
- Patients who do not accept blood products transfusions
- Other: Acceptance of blood-transfusions
- Patients who accept blood products transfusions
Arms, Groups and Cohorts
- Blood-transfusion non-acceptors
- Blood-transfusion non-acceptors
- Blood-transfusion acceptors
- Blood-transfusion acceptors
Clinical Trial Outcome Measures
Primary Measures
- Change on Hemoglobin values from preoperative to end-of-surgery levels
- Time Frame: End-of-surgery
- Changes on Hemoglobin values in percentage from preoperative level to the end of the surgery level
Secondary Measures
- Rate of operative mortality
- Time Frame: 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.
- Intraoperative fluid balance
- Time Frame: End of surgery
- Resting the fluid outputs to inputs
- Hemoglobin at discharge
- Time Frame: At discharge, an average of 10 days
- Hemoglobin level at discharge
- Rate of postoperative morbidity
- Time Frame: At discharge, an average of 10 days
- Postoperative complications: hemodynamic, respiratory, renal, neurological, infective complications
Participating in This Clinical Trial
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).
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 100 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Fundació Institut de Recerca de l’Hospital de la Santa Creu i Sant Pau
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Elena Roselló-Díez, MD, PhD, Principal Investigator, Cardiac surgeon
- Overall Contact(s)
- Elena Roselló-Díez, MD, PhD, +34 935565957, erosello@santpau.cat
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.