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

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