Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) Study

Completed

• Conditions: AKI; Prognosis; Blood Transfusion; Transcatheter Aortic Valve Implantation (TAVI); Aortic Valve Stenosis
• Interventions: Procedure: Blood Transfusion

• Registration Number: NCT03740425
• Lead Sponsor: G. d'Annunzio University

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).

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-11-10
• Study First Submitted QC: 2018-11-10
• Study First Posted: 2018-11-14
• Primary Completion: 2019-02-28
• Study Completion: 2019-03-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-16
• Last Update Posted: 2019-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3235

Inclusion Criteria

• patients undergoing transcatheter aortic valve implantation (TAVI)

Exclusion Criteria

• age<18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No Transfusion	Blood Transfusion	Patients not requiring blood transfusion after transcatheter aortic valve implantation (TAVI)
Transfusion	Blood Transfusion	Patients requiring blood transfusion after transcatheter aortic valve implantation (TAVI)

Primary Outcome Measures

Name	Time	Method
Major adverse cardiovascular events (MACE)	30 days and end of follow-up (3 years)	all-cause death, myocardial infarction (MI), stroke, or acute kidney injury (AKI)

Secondary Outcome Measures

Name	Time	Method
Death	30 days and end of follow-up (3 years)	all-cause death, cardiovascular death, non cardiovascular death

Trial Locations

Locations (1)

Santissima Annunziata Hospital; 🇮🇹 Chieti, Italy