Transcatheter Aortic Valve Implantation (TAVI)TRITAVINCT03740425
Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) Study
An observational study of Transcatheter Aortic Valve Implantation (TAVI) and Blood Transfusion, run by G. d'Annunzio University at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Transcatheter Aortic Valve Implantation (TAVI), Blood Transfusion, AKI
- What is being tested?
- Blood Transfusion
- Type of treatment
- Surgery or procedure
- How many people
- 3,235 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2018to 1 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All-consecutive patients referring at the participants centers undergoing transcatheter aortic valve implantation (TAVI)
Who may be able to join
- patients undergoing transcatheter aortic valve implantation (TAVI)
Who cannot join
- age<18 years
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Transcatheter Aortic Valve Implantation (TAVI), Blood Transfusion, AKI, Prognosis, Aortic Valve Stenosis
- Being tested
- Blood Transfusion
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood TransfusionProcedure or surgery
Blood Transfusion in patients who underwent transcatheter aortic valve implantation (TAVI)
| Study group | Role | What they receive |
|---|---|---|
| Transfusion | Patients requiring blood transfusion after transcatheter aortic valve implantation (TAVI) Receives: Procedure: Blood Transfusion | |
| No Transfusion | Patients not requiring blood transfusion after transcatheter aortic valve implantation (TAVI) Receives: Procedure: Blood Transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular events (MACE)
all-cause death, myocardial infarction (MI), stroke, or acute kidney injury (AKI)
Measured: 30 days and end of follow-up (3 years)
Secondary outcomes (1)
Death
all-cause death, cardiovascular death, non cardiovascular death
Measured: 30 days and end of follow-up (3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start1 Jan 2018
- Primary completion28 Feb 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Transcatheter Aortic Valve Implantation (TAVI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,235 participants (actual)
Sponsor and investigators
- Lead sponsor
- G. d'Annunzio University
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS Policlinico S. Donato, University Hospital, Catania, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Hospital Clínico Universitario de Valladolid
- Responsible party
- Principal investigator, Marco Zimarino, G. d'Annunzio University
- Investigators
- Marco Zimarino, MD, PhD, Principal investigator, G. d'Annunzio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03740425
- Sponsor's protocol ID
- TRITAVI18
- Acronym
- TRITAVI
- Status last verified
- Apr 2019
- First submitted
- 10 Nov 2018
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be shared only to other Participants Centers
Publications
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.
PubMed 29130845Mazer 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.
PubMed 30146969Pelliccia F, Pasceri V, Dangas G, Mehran R, Porto I, 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, Costa G, Fabbiocchi F, Chilmeran A, Stefanini G, Conrotto F, Tamburino C, Spaccarotella C, Cao D, Macchione A, La Torre M, Bendandi F, Wanha W, Wojakowski W, Benedetto U, Indolfi C, Hildick-Smith D, Capodanno D, Miraldi F, Dobrev D, Zimarino M; TRITAVI Study Group. Antiplatelet Therapy and All-Cause Mortality After Transcatheter Aortic Valve Replacement: The TRITAVI Registry. JACC Adv. 2026 May;5(5):102772. doi: 10.1016/j.jacadv.2026.102772.
PubMed 42206788Radico 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.
PubMed 39070183Zimarino 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.
PubMed 33272037
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) Study
- ClinicalTrials.gov ID
- NCT03740425
- Acronym / sponsor ID
- TRITAVI / TRITAVI18
- Conditions
- Transcatheter Aortic Valve Implantation (TAVI), Blood Transfusion, AKI, Prognosis, Aortic Valve Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,235 participants (actual)
- Lead sponsor
- G. d'Annunzio UniversityUniversity, hospital or other
- Collaborators
- IRCCS Policlinico S. Donato, University Hospital, Catania, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Hospital Clínico Universitario de Valladolid
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 14 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transfusion | – | Procedure: Blood TransfusionPatients requiring blood transfusion after transcatheter aortic valve implantation (TAVI) |
| No Transfusion | – | Procedure: Blood TransfusionPatients not requiring blood transfusion after transcatheter aortic valve implantation (TAVI) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All-consecutive patients referring at the participants centers undergoing transcatheter aortic valve implantation (TAVI)
Key inclusion criteria (1 listed)
- patients undergoing transcatheter aortic valve implantation (TAVI)
Key exclusion criteria (1 listed)
- age<18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood TransfusionBlood Transfusion in patients who underwent transcatheter aortic valve implantation (TAVI) | Procedure or surgery | No Transfusion, Transfusion |
Primary outcome
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)
1 secondary outcome
Death
Time frame: 30 days and end of follow-up (3 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Results publication: PubMed 29130845Mazer 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.
- Results publication: PubMed 30146969Mazer 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.
- Derived from this study: PubMed 42206788Pelliccia F, Pasceri V, Dangas G, Mehran R, Porto I, 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, Costa G, Fabbiocchi F, Chilmeran A, Stefanini G, Conrotto F, Tamburino C, Spaccarotella C, Cao D, Macchione A, La Torre M, Bendandi F, Wanha W, Wojakowski W, Benedetto U, Indolfi C, Hildick-Smith D, Capodanno D, Miraldi F, Dobrev D, Zimarino M; TRITAVI Study Group. Antiplatelet Therapy and All-Cause Mortality After Transcatheter Aortic Valve Replacement: The TRITAVI Registry. JACC Adv. 2026 May;5(5):102772. doi: 10.1016/j.jacadv.2026.102772.
- Derived from this study: PubMed 39070183Radico 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.
- Derived from this study: PubMed 33272037Zimarino 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.
- Individual participant dataSharing planned: Undecided. Data will be shared only to other Participants Centers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Zimarino, MD, PhD principal investigator
G. d'Annunzio University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transcatheter Aortic Valve Implantation (TAVI) and Blood Transfusion, run by G. d'Annunzio University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular events (MACE) (time frame: 30 days and end of follow-up (3 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03740425, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019.