Informations générales (source: ClinicalTrials.gov)
Antagonization of Heparin With Protamine Sulfate to Lower All Neurological Ischemic and Hemorrhagic Events After Transcatheter Aortic Valve Implantation for Aortic Stenosis
Interventional
Phase 3
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
mai 2025
mars 2027
13 septembre 2025
Transcatheter aortic valve replacement (TAVR) is now the first therapeutic option offered
to high and intermediate risk patients with symptomatic aortic stenosis but even to
low-risk, when the aortic valve is tricuspid and the transfemoral approach is suitable.
Vascular and bleeding complications are the most frequent procedure-related unwanted
events associated with increased short-term morbidity and mortality. Selection of the
appropriate vascular access site and pre-closing devices as well as stent implantation
mitigate these complications.
ACT-guided heparin reaching a target of 300 seconds or more is recommended prior to the
placement of the guiding sheath in the common femoral artery. Protamine sulfate is the
heparin antidote, which antagonizes 100% of its anti-IIa activity and 60% of its anti-Xa
activity. Reversal of heparin using protamine sulfate is recommended for transapical and
complicated transfemoral aortic valve placement.However, there is a great heterogeneity
of protamine use in daily practice and supportive evidence for the prevention of bleeding
complications as well as its safety is lacking. In addition, the radial approach for the
second vascular access is more commonly used as well as the use of echo-guided femoral
puncture further questioning reversal of heparin when the procedure has been successfully
completed without overt bleeding complications.
Our study aims to demonstrate the superiority of a strategy of systematic ACT-guided
heparin administration followed by systematic antagonization with protamine sulfate over
usual of care to reduce in-hospital mortality, vascular/bleeding complications, stroke
and transcient ischemic attack, myocardial infarction or red blood cell transfusion, from
randomization to hospital discharge
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL PRIVE JACQUES CARTIER | GUEDENEY Paul | 18/09/2025 17:33:39 | Contacter | ||
| AP-HP Assistance publique - Hôpitaux de Paris | 18/09/2025 17:33:39 | Contacter | |||
| AP-HP - Hôpital Europeen Georges Pompidou | |||||
| AP-HP - Hôpital La Pitié-Salpêtrière | |||||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| 18/09/2025 17:33:39 | Contact (sur clinicalTrials) | ||||
| 18/09/2025 17:33:39 | Contact (sur clinicalTrials) | ||||
| 18/09/2025 17:33:39 | Contact (sur clinicalTrials) | ||||
| 18/09/2025 17:33:39 | Contact (sur clinicalTrials) | ||||
Critères
Tous
- Men and women ≥18 years of age
- Any patient eligible for transfemoral TAVI, irrespective of the chronic
antithrombotic treatment
- Written informed consent
- Registered at the French social healthcare
Exclusion Criteria:
- Any major protamine sulfate exposure contraindications defined as a history of
severe pulmonary hypertension, acute pulmonary edema or history of bronchospasm
related to protamine sulfate administration
- Known allergy to protamine sulfate
- Hypersensitivity to protamine sulfate including protamine contained as an excipient
in NPH [Neutral Protamine Hagedorn] insulin, known protamine or protamine-heparine
complex antibodies
- Non-femoral approach for the TAVI procedure
- Protamine sulfate exposure within 24h of randomization
- Fish allergy
- Mechanical valves
- For men: Sterile or Vasectomy
- Women of childbearing potential
- Pregnancy and breast feeding women
- Contemporaneous enrolment in an interventional clinical trial
- Patient under guardianship or curatorship