Clinical trial NCT03740425: Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) Study
Official title: Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transcatheter Aortic Valve Implantation (TAVI)
Blood Transfusion
AKI
Prognosis
Aortic Valve Stenosis
Lead sponsor: G. d'Annunzio University
Sponsor class: OTHER
Collaborators: name: IRCCS Policlinico S. Donato
name: University Hospital, Catania
name: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Hospital Clínico Universitario de Valladolid
First posted: 2018-11-14
Enrollment: 3235
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All-consecutive patients referring at the participants centers undergoing 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).

Eligibility criteria: Inclusion Criteria:

* patients undergoing transcatheter aortic valve implantation (TAVI)

Exclusion Criteria:

* age\<18 years

Primary outcomes:
measure: Major adverse cardiovascular events (MACE)
timeFrame: 30 days and end of follow-up (3 years)
Secondary outcomes:
measure: Death
timeFrame: 30 days and end of follow-up (3 years)
Other outcomes:
measure: Myocardial infarction
timeFrame: 30 days and end of follow-up (3 years)
measure: acute kidney injury (AKI)
timeFrame: 30 days
measure: stroke
timeFrame: 30 days and end of follow-up (3 years)
Locations:
city: Chieti
country: Italy
facility: Santissima Annunziata Hospital
Study officials:
affiliation: G. d'Annunzio University
name: Marco Zimarino, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mazer CD, Whitlock RP, Fergusson DA, Hall J, Belley-Cote E, Connolly K, Khanykin B, Gregory AJ, de Medicis E, McGuinness S, Royse A, Carrier FM, Young PJ, Villar JC, Grocott HP, Seeberger MD, Fremes S, Lellouche F, Syed S, Byrne K, Bagshaw SM, Hwang NC, Mehta C, Painter TW, Royse C, Verma S, Hare GMT, Cohen A, Thorpe KE, Juni P, Shehata N; TRICS Investigators and Perioperative Anesthesia Clinical Trials Group. Restrictive or Liberal Red-Cell Transfusion for Cardiac Surgery. N Engl J Med. 2017 Nov 30;377(22):2133-2144. doi: 10.1056/NEJMoa1711818. Epub 2017 Nov 12.
citation: Mazer CD, Whitlock RP, Fergusson DA, Belley-Cote E, Connolly K, Khanykin B, Gregory AJ, de Medicis E, Carrier FM, McGuinness S, Young PJ, Byrne K, Villar JC, Royse A, Grocott HP, Seeberger MD, Mehta C, Lellouche F, Hare GMT, Painter TW, Fremes S, Syed S, Bagshaw SM, Hwang NC, Royse C, Hall J, Dai D, Mistry N, Thorpe K, Verma S, Juni P, Shehata N; TRICS Investigators and Perioperative Anesthesia Clinical Trials Group. Six-Month Outcomes after Restrictive or Liberal Transfusion for Cardiac Surgery. N Engl J Med. 2018 Sep 27;379(13):1224-1233. doi: 10.1056/NEJMoa1808561. Epub 2018 Aug 26.
citation: Zimarino M, Barbanti M, Dangas GD, Testa L, Capodanno D, Stefanini GG, Radico F, Marchioni M, Amat-Santos I, Piva T, Saia F, Reimers B, De Innocentiis C, Picchi A, Toro A, Rodriguez-Gabella T, Nicolini E, Moretti C, Gallina S, Maddestra N, Bedogni F, Tamburino C. Early Adverse Impact of Transfusion After Transcatheter Aortic Valve Replacement: A Propensity-Matched Comparison From the TRITAVI Registry. Circ Cardiovasc Interv. 2020 Dec;13(12):e009026. doi: 10.1161/CIRCINTERVENTIONS.120.009026. Epub 2020 Dec 4.