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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04609228
Other study ID # IIBSP-TRA-2020-36
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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
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