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| Name | Class |
|---|---|
| St. Antonius Research Fund | UNKNOWN |
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Heparin reversal by protamine administration after transcatheter aortic valve implantation (TAVI) may reduce bleeding events. However, protamine can also cause life-threatening allergic reactions. High-quality evidence regarding the clinical safety and efficacy of routine protamine administration after TAVI is lacking.
The aim of this clinical trial is to determine if routine protamine administration, compared with selective protamine administration, reduces the risk of all-cause mortality or clinically relevant bleeding within 30 days after transcatheter aortic valve implantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Routine protamine administration | Active Comparator | Routine protamine administration in a ratio of 1 IE per 1 IE of unfractionated heparin. |
|
| Selective protamine administration | Active Comparator | Selective protamine administration, in case of (threatening) bleeding. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protamine sulfate | Drug | Routine protamine administration in a ratio of 1 IE per 1 IE of unfractionated heparin. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite of all-cause mortality or type 1-4 bleeding | According to the VARC-3 criteria | 30 days after TAVI |
| Measure | Description | Time Frame |
|---|---|---|
| All bleeding | According to the VARC-3 criteria type 1-4 bleeding | 30 days after TAVI |
| Major, life-threatening or fatal bleeding | According to the VARC-3 criteria type 2-4 bleeding |
| Measure | Description | Time Frame |
|---|---|---|
| Safety endpoint: Anaphylaxis | According to the National Institute of Allergy and Infectious Disease criteria | 30 days after TAVI |
| Safety endpoint: Thromboembolic events | Composite of myocardial infarction, ischaemic stroke, transient ischaemic attack or non-cerebral distal embolization according to the VARC-3 criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A.S.Z. Aalst | Aalst | Belgium | ||||
| University Hospitals Leuven |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41177203 | Derived | Overduin DC, van Ginkel DJ, Dubois C, Lesizza P, Broeze GM, Montero-Cabezas JM, Rosseel L, van der Kley F, van Nuland PJ, Smits TP, Hemelrijk KI, Aarts HM, Rensing BJWM, Timmers L, Swaans MJ, Sonker U, Veenstra L, van 't Hof AWJ, Peper J, Tijssen JGP, Delewi R, Vriesendorp PA, Ten Berg JM. Routine versus selective protamine administration to reduce bleeding after TAVI: Rationale and design of the POPular ACE TAVI trial. Am Heart J. 2026 Mar;293:107296. doi: 10.1016/j.ahj.2025.107296. Epub 2025 Oct 31. |
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Parallel Assignment
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| Protamine sulfate | Drug | Selective protamine administration, in case of (threatening) bleeding |
|
|
| 30 days after TAVI |
| Major vascular complications | According to the VARC-3 criteria | 30 days after TAVI |
| Cardiovascular mortality | According to the VARC-3 criteria | 30 days after TAVI |
| All-cause mortality | According to the VARC-3 criteria | 30 days after TAVI |
| 30 days after TAVI |
| Neurologic events | According to the VARC-3 criteria | 30 days after TAVI |
| Hospitalization | According to the VARC-3 criteria | 30 days after TAVI |
| Vascular and access-related complications | According to the VARC-3 criteria | 30 days after TAVI |
| Cardiac structural complications | According to the VARC-3 criteria | 30 days after TAVI |
| Other procedural or valve-related complications | According to the VARC-3 criteria | 30 days after TAVI |
| New conduction disturbances and arrhythmias | According to the VARC-3 criteria | 30 days after TAVI |
| Acute kidney injury | According to the VARC-3 criteria | 30 days after TAVI |
| Myocardial infarction | According to the VARC-3 criteria | 30 days after TAVI |
| Bioprosthetic valve dysfunction | According to the VARC-3 criteria | 30 days after TAVI |
| Leaflet thickening and reduced motion | According to the VARC-3 criteria | 30 days after TAVI |
| Clinically significant valve thrombosis | According to the VARC-3 criteria | 30 days after TAVI |
| Time to hemostasis | Is defined as elapsed time after sheath removal and first observed and confirmed arterial hemostasis. | 30 days after TAVI |
| Haemoglobin level | 30 days after TAVI |
| Need for transfusion | Any bleeding requiring transfusion of 1 or more units of whole blood/RBC | 30 days after TAVI |
| Procedural haemostasis failure | Procedural haemostasis failure is defined as failure to achieve haemostasis at the arteriotomy site within 20 minutes or leading to alternative treatment (e.g. fem-stop device, or adjunctive endovascular ballooning/stenting). | 30 days after TAVI |
| Delayed haemostasis failure | The occurrence of bleeding requiring prolonged manual compression or alternative interventions (new pressure bandage, fem-stop device, endovascular or surgical repair) after initial haemostasis was achieved and patient is no longer in the catheterization laboratory. | 30 days after TAVI |
| Post-procedural length of stay | Post-procedural length of stay will be measured in the time (days) from procedure to discharge. | 30 days after TAVI |
| Freedom from mortality | According to the VARC-3 criteria | 30 days after TAVI |
| Successful access, delivery of the device, and retrieval of the delivery system | According to the VARC-3 criteria | 30 days after TAVI |
| Correct positioning of a single prosthetic heart valve into the proper anatomical location | According to the VARC-3 criteria | 30 days after TAVI |
| Freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication | According to the VARC-3 criteria | 30 days after TAVI |
| Technical success | According to the VARC-3 criteria | 30 days after TAVI |
| Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication | According to the VARC-3 criteria | 30 days after TAVI |
| Intended performance of the valve (mean gradient <20 mmHg, peak velocity <3 m/s, Doppler velocity index ≥0.25, and less than moderate aortic regurgitation) | According to the VARC-3 criteria | 30 days after TAVI |
| Freedom from all-cause mortality | According to the VARC-3 criteria | 30 days after TAVI |
| Freedom from all stroke | According to the VARC-3 criteria | 30 days after TAVI |
| Freedom from VARC type 2-4 bleeding | According to the VARC-3 criteria | 30 days after TAVI |
| Freedom from major vascular, access-related, or cardiac structural complication | According to the VARC-3 criteria | 30 days after TAVI |
| Freedom from acute kidney injury stage 3 or 4 | According to the VARC-3 criteria | 30 days after TAVI |
| Freedom from moderate or severe aortic regurgitation | According to the VARC-3 criteria | 30 days after TAVI |
| Freedom from new permanent pacemaker due to procedure-related conduction abnormalities | According to the VARC-3 criteria | 30 days after TAVI |
| Freedom from surgery or intervention related to the device | According to the VARC-3 criteria | 30 days after TAVI |
| Leuven |
| Belgium |
| Maastricht UMC | Maastricht | Limburg | Netherlands |
| Leiden University Medical Center | Leiden | South Holland | Netherlands |
| St. Antonius Hospital | Nieuwegein | Utrecht | Netherlands |
| Amsterdam University Medical Center | Amsterdam | Netherlands |
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D006470 | Hemorrhage |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D011479 | Protamines |
| ID | Term |
|---|---|
| D009687 | Nuclear Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009698 | Nucleoproteins |
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