Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) Study

Aortic Valve Stenosis Clinical Trial

— TRITAVI  

Official title:

Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03740425
• Other study ID #: TRITAVI18
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: April 2019
• Source: G. d'Annunzio University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3235
• Est. completion date: March 1, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• patients undergoing transcatheter aortic valve implantation (TAVI)

Exclusion Criteria:

• age<18 years

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Italy	Santissima Annunziata Hospital	Chieti

Sponsors (5)

Lead Sponsor	Collaborator
G. d'Annunzio University	Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi, Hospital Clínico Universitario de Valladolid, IRCCS Policlinico S. Donato, University Hospital, Catania

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Mazer CD, Whitlock RP, Fergusson DA, Belley-Cote E, Connolly K, Khanykin B, Gregory AJ, de Médicis É, 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, — View Citation

Mazer CD, Whitlock RP, Fergusson DA, Hall J, Belley-Cote E, Connolly K, Khanykin B, Gregory AJ, de Médicis É, 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, M — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Myocardial infarction	Myocardial infarction	30 days and end of follow-up (3 years)
Other	acute kidney injury (AKI)	need for dialYsis or increase in serum creatinine =0.3 mg/dL [=26.4 µmol/L] or =50% increase =72 hours	30 days
Other	stroke	stroke or transient ischemic attack (TIA)	30 days and end of follow-up (3 years)
Primary	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	Death	all-cause death, cardiovascular death, non cardiovascular death	30 days and end of follow-up (3 years)