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Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) Study (TRITAVI)

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ClinicalTrials.gov Identifier: NCT03740425
Recruitment Status : Completed
First Posted : November 14, 2018
Last Update Posted : April 18, 2019
Sponsor:
Collaborators:
IRCCS Policlinico S. Donato
University Hospital, Catania
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Hospital Clínico Universitario de Valladolid
Information provided by (Responsible Party):
Marco Zimarino, 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.


Condition or disease Intervention/treatment
Transcatheter Aortic Valve Implantation (TAVI) Blood Transfusion AKI Prognosis Aortic Valve Stenosis Procedure: Blood Transfusion

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).


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Study Type : Observational
Actual Enrollment : 3235 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) Study
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : February 28, 2019
Actual Study Completion Date : March 1, 2019


Group/Cohort Intervention/treatment
Transfusion
Patients requiring blood transfusion after transcatheter aortic valve implantation (TAVI)
Procedure: 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)
Procedure: Blood Transfusion
Blood Transfusion in patients who underwent transcatheter aortic valve implantation (TAVI)




Primary Outcome Measures :
  1. Major adverse cardiovascular events (MACE) [ Time Frame: 30 days and end of follow-up (3 years) ]
    all-cause death, myocardial infarction (MI), stroke, or acute kidney injury (AKI)


Secondary Outcome Measures :
  1. Death [ Time Frame: 30 days and end of follow-up (3 years) ]
    all-cause death, cardiovascular death, non cardiovascular death


Other Outcome Measures:
  1. Myocardial infarction [ Time Frame: 30 days and end of follow-up (3 years) ]
    Myocardial infarction

  2. acute kidney injury (AKI) [ Time Frame: 30 days ]
    need for dialYsis or increase in serum creatinine ≥0.3 mg/dL [≥26.4 μmol/L] or ≥50% increase ≤72 hours

  3. stroke [ Time Frame: 30 days and end of follow-up (3 years) ]
    stroke or transient ischemic attack (TIA)



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All-consecutive patients referring at the participants centers undergoing transcatheter aortic valve implantation (TAVI)
Criteria

Inclusion Criteria:

  • patients undergoing transcatheter aortic valve implantation (TAVI)

Exclusion Criteria:

  • age<18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03740425


Locations
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Italy
Santissima Annunziata Hospital
Chieti, Italy
Sponsors and Collaborators
G. d'Annunzio University
IRCCS Policlinico S. Donato
University Hospital, Catania
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Hospital Clínico Universitario de Valladolid
Investigators
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Principal Investigator: Marco Zimarino, MD, PhD G. d'Annunzio University

Publications of Results:
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Responsible Party: Marco Zimarino, MD, PhD, G. d'Annunzio University
ClinicalTrials.gov Identifier: NCT03740425     History of Changes
Other Study ID Numbers: TRITAVI18
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data will be shared only to other Participants Centers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction