Skip to main content
OpenTrials
Completed

NCT Number: NCT03740425

Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Santissima Annunziata Hospital

Chieti, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients undergoing transcatheter aortic valve implantation (TAVI)

Exclusion criteria

  • age<18 years

Treatment and study plan

Blood Transfusion

Procedure

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

Primary outcomes

  1. Major adverse cardiovascular events (MACE)

    Time frame: 30 days and end of follow-up (3 years)

    all-cause death, myocardial infarction (MI), stroke, or acute kidney injury (AKI)

Secondary outcomes

  1. Death

    Time frame: 30 days and end of follow-up (3 years)

    all-cause death, cardiovascular death, non cardiovascular death

Other outcomes

  1. Myocardial infarction

    Time frame: 30 days and end of follow-up (3 years)

    Myocardial infarction

  2. acute kidney injury (AKI)

    Time frame: 30 days

    need for dialYsis or increase in serum creatinine ≥0.3 mg/dL [≥26.4 μmol/L] or ≥50% increase ≤72 hours

  3. stroke

    Time frame: 30 days and end of follow-up (3 years)

    stroke or transient ischemic attack (TIA)

Sponsors and collaborators

Lead sponsor

G. d'Annunzio University

Other

Collaborators

  • Hospital Clínico Universitario de Valladolid
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna
  • IRCCS Policlinico S. Donato
  • University Hospital, Catania

Registry information

Acronym: TRITAVI

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 14, 2018
Registry last updated
Apr 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.