Brief Title
Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) Study
Official Title
Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) Study
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).
Study Type
Observational
Primary Outcome
Major adverse cardiovascular events (MACE)
Secondary Outcome
Death
Condition
Transcatheter Aortic Valve Implantation (TAVI)
Intervention
Blood Transfusion
Study Arms / Comparison Groups
Transfusion
Description: Patients requiring blood transfusion after transcatheter aortic valve implantation (TAVI)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
3235
Start Date
January 1, 2018
Completion Date
March 1, 2019
Primary Completion Date
February 28, 2019
Eligibility Criteria
Inclusion Criteria:
- patients undergoing transcatheter aortic valve implantation (TAVI)
Exclusion Criteria:
- age<18 years
Gender
All
Ages
18 Years - 100 Years
Accepts Healthy Volunteers
No
Contacts
Marco Zimarino, MD, PhD, ,
Location Countries
Italy
Location Countries
Italy
Administrative Informations
NCT ID
NCT03740425
Organization ID
TRITAVI18
Responsible Party
Principal Investigator
Study Sponsor
G. d'Annunzio University
Collaborators
IRCCS Policlinico S. Donato
Study Sponsor
Marco Zimarino, MD, PhD, Principal Investigator, G. d'Annunzio University
Verification Date
April 2019