Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Transfusion Patients requiring blood transfusion after transcatheter aortic valve implantation (TAVI) |
Procedure: Blood Transfusion
Blood Transfusion in patients who underwent transcatheter aortic valve implantation (TAVI)
|
| No Transfusion Patients not requiring blood transfusion after transcatheter aortic valve implantation (TAVI) |
Procedure: Blood Transfusion
Blood Transfusion in patients who underwent transcatheter aortic valve implantation (TAVI)
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Death [30 days and end of follow-up (3 years)]
all-cause death, cardiovascular death, non cardiovascular death
Other Outcome Measures
- Myocardial infarction [30 days and end of follow-up (3 years)]
Myocardial infarction
- acute kidney injury (AKI) [30 days]
need for dialYsis or increase in serum creatinine ≥0.3 mg/dL [≥26.4 μmol/L] or ≥50% increase ≤72 hours
- stroke [30 days and end of follow-up (3 years)]
stroke or transient ischemic attack (TIA)
Eligibility Criteria
Criteria
Inclusion Criteria:
- patients undergoing transcatheter aortic valve implantation (TAVI)
Exclusion Criteria:
- age<18 years
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Santissima Annunziata Hospital | Chieti | Italy |
Sponsors and Collaborators
- G. d'Annunzio University
- IRCCS Policlinico S. Donato
- University Hospital, Catania
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Hospital Clínico Universitario de Valladolid
Investigators
- Principal Investigator: Marco Zimarino, MD, PhD, G. d'Annunzio University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TRITAVI18