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Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) Study

Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03740425
Acronym
TRITAVI
Enrollment
3235
Registered
2018-11-14
Start date
2018-01-01
Completion date
2019-03-01
Last updated
2019-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AKI, Aortic Valve Stenosis, Blood Transfusion, Prognosis, Transcatheter Aortic Valve Implantation (TAVI)

Brief summary

Periprocedural bleeding events are frequent during transcatheter aortic valve implantation (TAVI), mainly driven by vascular complications and are associated to a worse prognosis. Therefore, red blood cell (RBC) transfusion is often required, although it is associated with worsened outcomes. There is no consensus on the optimal transfusion strategy after bleeding. The Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) will be a multicenter retrospective registry enrolling consecutive patients who underwent TAVI; the primary aim of the study will be to test whether RBC transfusion is a marker or an independent predictor of adverse events.

Detailed description

Periprocedural bleeding events are frequent during transcatheter aortic valve implantation (TAVI), mainly driven by vascular complications and are associated to a worse prognosis. Therefore, red blood cell (RBC) transfusion is often required, although it is associated with worsened outcomes. There is no consensus on the optimal transfusion strategy after bleeding: among patients undergoing cardiac surgery, the Transfusion Requirements in Cardiac Surgery (TRICS) III trial documented that a restrictive RBC transfusion strategy (if hemoglobin level was \<7.5 g/dl) was noninferior to a liberal approach (if hemoglobin level was \<9.5 g/dl) with respect to the composite occurrence of death, myocardial infarction (MI), stroke, or new-onset renal failure with dialysis. The Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) will be a multicenter retrospective registry enrolling consecutive patients who underwent TAVI; the primary aim of the study will be to test whether RBC transfusion is a marker or an independent predictor of adverse events. Patients will be stratified according to their lowest hemoglobin value (\>9.5 g/dl, 7.5-9.5 g/dl and \<7.5 g/dl) and to whether they received or not periprocedural RBC transfusion. The primary endpoint will be the 30-day occurrence of major adverse cardiovascular events (MACE), as death, myocardial infarction (MI), stroke, or acute kidney injury (AKI, as absolute increase in serum creatinine ≥0.3 mg/dL \[≥26.4 μmol/L\] or ≥50% increase ≤72 hours).

Interventions

PROCEDUREBlood Transfusion

Blood Transfusion in patients who underwent transcatheter aortic valve implantation (TAVI)

Sponsors

IRCCS Policlinico S. Donato
CollaboratorOTHER
University Hospital, Catania
CollaboratorOTHER
IRCCS Azienda Ospedaliero-Universitaria di Bologna
CollaboratorOTHER
Hospital Clínico Universitario de Valladolid
CollaboratorOTHER
G. d'Annunzio University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* patients undergoing transcatheter aortic valve implantation (TAVI)

Exclusion criteria

* age\<18 years

Design outcomes

Primary

MeasureTime frameDescription
Major adverse cardiovascular events (MACE)30 days and end of follow-up (3 years)all-cause death, myocardial infarction (MI), stroke, or acute kidney injury (AKI)

Secondary

MeasureTime frameDescription
Death30 days and end of follow-up (3 years)all-cause death, cardiovascular death, non cardiovascular death

Other

MeasureTime frameDescription
Myocardial infarction30 days and end of follow-up (3 years)Myocardial infarction
acute kidney injury (AKI)30 daysneed for dialYsis or increase in serum creatinine ≥0.3 mg/dL \[≥26.4 μmol/L\] or ≥50% increase ≤72 hours
stroke30 days and end of follow-up (3 years)stroke or transient ischemic attack (TIA)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026