Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) Study

NCT03740425 | Completed

• 1 other identifier: TRITAVI18
• Study Type: observational
• Target: 3,235
• Locations: 1 country
• Sites: 1

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.

Conditions

Transcatheter Aortic Valve Implantation (TAVI); Blood Transfusion; AKI; Prognosis; Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiovascular events (MACE)

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

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

Secondary Outcomes (1)

• Death

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

Other Outcomes (3)

• Myocardial infarction

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

• acute kidney injury (AKI)

  30 days

• stroke

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

Study Arms (2)

Transfusion

Patients requiring blood transfusion after transcatheter aortic valve implantation (TAVI)

Procedure: Blood Transfusion

No Transfusion

Patients not requiring blood transfusion after transcatheter aortic valve implantation (TAVI)

Procedure: Blood Transfusion

Interventions

Blood Transfusion PROCEDURE

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

No Transfusion; Transfusion

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All-consecutive patients referring at the participants centers undergoing transcatheter aortic valve implantation (TAVI)

You may qualify if:

• patients undergoing transcatheter aortic valve implantation (TAVI)

You may not qualify if:

• age\<18 years

Sponsors & Collaborators

• G. d'Annunzio University: lead
• IRCCS Policlinico S. Donato: collaborator
• University Hospital, Catania: collaborator
• IRCCS Azienda Ospedaliero-Universitaria di Bologna: collaborator
• Hospital Clínico Universitario de Valladolid: collaborator

Study Sites (1)

Santissima Annunziata Hospital

Chieti, Italy

Location

Related Publications (4)

• 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.

  PMID: 29130845 RESULT

• 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.

  PMID: 30146969 RESULT

• 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.

  PMID: 39070183 DERIVED

• 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.

  PMID: 33272037 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Blood Transfusion

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Marco Zimarino, MD, PhD

  G. d'Annunzio University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: November 10, 2018
• First Posted: November 14, 2018
• Study Start: January 1, 2018
• Primary Completion: February 28, 2019
• Study Completion: March 1, 2019
• Last Updated: April 18, 2019

Record last verified: 2019-04

Locations

IT (1)