Cardiac Surgery Outcomes in Blood-transfusion Acceptors and no Acceptors

March 15, 2022 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1911

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Barcelona, Spain, 08025
        • Recruiting
        • Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Blood-transfusion non-acceptors
Other: Non-acceptance of blood-transfusions
Patients who do not accept blood products transfusions
Blood-transfusion acceptors
Other: Acceptance of blood-transfusions
Patients who accept blood products transfusions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
End-of-surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Elena Roselló-Díez, MD, PhD, Cardiac surgeon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2020

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

October 15, 2020

First Submitted That Met QC Criteria

October 29, 2020

First Posted (Actual)

October 30, 2020

Study Record Updates

Last Update Posted (Actual)

March 16, 2022

Last Update Submitted That Met QC Criteria

March 15, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-TRA-2020-36

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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