Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) Study

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

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