Cardiac Surgery Outcomes in Blood-transfusion Acceptors and no Acceptors
1 other identifier
observational
1,911
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 15, 2020
CompletedFirst Posted
Study publicly available on registry
October 30, 2020
CompletedStudy Start
First participant enrolled
October 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedMarch 16, 2022
March 1, 2022
1.9 years
October 15, 2020
March 15, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Rate of operative mortality
At discharge or within the first 30 postoperative days
Intraoperative fluid balance
End of surgery
Hemoglobin at discharge
At discharge, an average of 10 days
Rate of postoperative morbidity
At discharge, an average of 10 days
Study Arms (2)
Blood-transfusion non-acceptors
Blood-transfusion non-acceptors
Blood-transfusion acceptors
Blood-transfusion acceptors
Interventions
Patients who do not accept blood products transfusions
Patients who accept blood products transfusions
Eligibility Criteria
Patients undergoing heart surgery in our hospital from 2009 to June 2020. Patients were categorized in blood-transfusion non-acceptors (exposed cohort) and blood-transfusion acceptors (control cohort)
You may qualify if:
- Patients undergoing heart surgery in our hospital from 2009 to June 2020
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau
Barcelona, 08025, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elena Roselló-Díez, MD, PhD
Cardiac surgeon
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2020
First Posted
October 30, 2020
Study Start
October 30, 2020
Primary Completion
October 1, 2022
Study Completion
October 1, 2022
Last Updated
March 16, 2022
Record last verified: 2022-03