Thoracic SurgeryNCT04609228
Cardiac Surgery Outcomes in Blood-transfusion Acceptors and no Acceptors
An observational study of Thoracic Surgery and Blood Transfusion; Hemoglobinemia, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Thoracic Surgery, Blood Transfusion; Hemoglobinemia, Cardiac Disease
- What is being tested?
- Non-acceptance of blood-transfusions and Acceptance of blood-transfusions
- How many people
- 1,911 participants
- Where
- 1 siteSpain
- Study dates
- 30 Oct 2020to 1 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- Patients undergoing heart surgery in our hospital from 2009 to June 2020
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Elena Roselló-Díez, MD, PhD, +34 935565957, erosello@santpau.cat
About this study
Official title: 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.
- Being tested
- Non-acceptance of blood-transfusions, Acceptance of blood-transfusions
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-acceptance of blood-transfusionsOther
Patients who do not accept blood products transfusions
Acceptance of blood-transfusionsOther
Patients who accept blood products transfusions
| Study group | Role | What they receive |
|---|---|---|
| Blood-transfusion non-acceptors | Blood-transfusion non-acceptors Receives: Other: Non-acceptance of blood-transfusions | |
| Blood-transfusion acceptors | Blood-transfusion acceptors Receives: Other: Acceptance of blood-transfusions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: End-of-surgery
Secondary outcomes (4)
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.
Measured: At discharge or within the first 30 postoperative days
Intraoperative fluid balance
Resting the fluid outputs to inputs
Measured: End of surgery
Hemoglobin at discharge
Hemoglobin level at discharge
Measured: At discharge, an average of 10 days
Rate of postoperative morbidity
Postoperative complications: hemodynamic, respiratory, renal, neurological, infective complications
Measured: At discharge, an average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start30 Oct 2020
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic SurgeryStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,911 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elena Roselló-Díez, MD, PhD, Principal investigator, Cardiac surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04609228
- Sponsor's protocol ID
- IIBSP-TRA-2020-36
- Status last verified
- Mar 2022
- First submitted
- 15 Oct 2020
- Last updated
- 16 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Surgery Outcomes in Blood-transfusion Acceptors and no Acceptors: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT04609228
- Acronym / sponsor ID
- IIBSP-TRA-2020-36
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,911 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 30 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood-transfusion non-acceptors | – | Other: Non-acceptance of blood-transfusionsBlood-transfusion non-acceptors |
| Blood-transfusion acceptors | – | Other: Acceptance of blood-transfusionsBlood-transfusion acceptors |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (1 listed)
- Patients undergoing heart surgery in our hospital from 2009 to June 2020
Key exclusion criteria (6 listed)
- Preoperative hemoglobin lower than 120g/L
- EuroSCORE-II higher than 20%
- Heart transplant
- Assist device implantation
- Surgery of acute myocardial infarction-derived complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-acceptance of blood-transfusionsPatients who do not accept blood products transfusions | Other | Blood-transfusion non-acceptors |
| Acceptance of blood-transfusionsPatients who accept blood products transfusions | Other | Blood-transfusion acceptors |
Primary outcome
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
4 secondary outcomes
Rate of operative mortality
Time frame: At discharge or within the first 30 postoperative days
Intraoperative fluid balance
Time frame: End of surgery
Hemoglobin at discharge
Time frame: At discharge, an average of 10 days
Rate of postoperative morbidity
Time frame: At discharge, an average of 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Individual participant dataSharing planned: Undecided. Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Roselló-Díez, MD, PhD principal investigator
Cardiac surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Surgery and Blood Transfusion; Hemoglobinemia, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elena Roselló-Díez, MD, PhD (+34 935565957, erosello@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change on Hemoglobin values from preoperative to end-of-surgery levels (time frame: End-of-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.