Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) Study
NCT ID: NCT03740425
Last Updated: 2019-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
3235 participants
OBSERVATIONAL
2018-01-01
2019-03-01
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Transfusion
Patients requiring blood transfusion after transcatheter aortic valve implantation (TAVI)
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)
Blood Transfusion
Blood Transfusion in patients who underwent transcatheter aortic valve implantation (TAVI)
Interventions
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Blood Transfusion
Blood Transfusion in patients who underwent transcatheter aortic valve implantation (TAVI)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
100 Years
ALL
No
Sponsors
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IRCCS Policlinico S. Donato
OTHER
University Hospital, Catania
OTHER
IRCCS Azienda Ospedaliero-Universitaria di Bologna
OTHER
Hospital Clínico Universitario de Valladolid
OTHER
G. d'Annunzio University
OTHER
Responsible Party
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Marco Zimarino
MD, PhD
Principal Investigators
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Marco Zimarino, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
G. d'Annunzio University
Locations
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Santissima Annunziata Hospital
Chieti, , Italy
Countries
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References
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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.
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.
Radico F, Biancari F, D'Ascenzo F, Saia F, Luzi G, Bedogni F, Amat-Santos IJ, De Marzo V, Dimagli A, Makikallio T, Stabile E, Blasco-Turrion S, Testa L, Barbanti M, Tamburino C, Porto I, Fabiocchi F, Conrotto F, Pelliccia F, Costa G, Stefanini GG, Macchione A, La Torre M, Bendandi F, Juvonen T, Pasceri V, Wanha W, Benedetto U, Miraldi F, Dobrev D, Zimarino M. Red blood cell transfusion and mortality after transcatheter aortic valve implantation via transapical approach: A propensity-matched comparison from the TRITAVI registry. Int J Cardiol Heart Vasc. 2024 Jul 6;53:101460. doi: 10.1016/j.ijcha.2024.101460. eCollection 2024 Aug.
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.
Other Identifiers
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TRITAVI18
Identifier Type: -
Identifier Source: org_study_id
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