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Cardiac Surgery Outcomes in Blood-transfusion Acceptors and no Acceptors

Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other)
Overall Status
Recruiting
CT.gov ID
NCT04609228
Collaborator
(none)
1,911
Enrollment
1
Location
23
Anticipated Duration (Months)
83
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Non-acceptance of blood-transfusions
  • Other: Acceptance of blood-transfusions

Study Design

Study Type:
Observational
Anticipated Enrollment :
1911 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Cardiac Surgery Outcomes in Blood-transfusion Acceptors and no Acceptors: a Retrospective Cohort Study
Actual Study Start Date :
Oct 30, 2020
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Blood-transfusion non-acceptors

Blood-transfusion non-acceptors

Other: Non-acceptance of blood-transfusions
Patients who do not accept blood products transfusions
Blood-transfusion acceptors

Blood-transfusion acceptors

Other: Acceptance of blood-transfusions
Patients who accept blood products transfusions

Outcome Measures

Primary Outcome Measures

  1. Change on Hemoglobin values from preoperative to end-of-surgery levels [End-of-surgery]

    Changes on Hemoglobin values in percentage from preoperative level to the end of the surgery level

Secondary Outcome Measures

  1. Rate of operative mortality [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.

  2. Intraoperative fluid balance [End of surgery]

    Resting the fluid outputs to inputs

  3. Hemoglobin at discharge [At discharge, an average of 10 days]

    Hemoglobin level at discharge

  4. Rate of postoperative morbidity [At discharge, an average of 10 days]

    Postoperative complications: hemodynamic, respiratory, renal, neurological, infective complications

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau Barcelona Spain 08025

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT04609228
Other Study ID Numbers:
  • IIBSP-TRA-2020-36
First Posted:
Oct 30, 2020
Last Update Posted:
Mar 16, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Heart Diseases

Study Results

No Results Posted as of Mar 16, 2022