Antagonization of Heparin With Protamine Sulfate After TAVI
Key facts
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Where
- France1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 940 people, planned
- Started
- 25 May 2025
- Expected to end
- 1 Mar 2027
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Antagonization of heparin with protamine sulfate
- Record updated
- 22 August 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Fish allergy
- Non-femoral approach for the TAVI procedure
- Protamine sulfate exposure within 24h of randomization
- 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
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
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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
The 2 groups in the trial
- Systematic heparine antagonization with protamine sulphateTreatment being tested
Complete reversal of the Heparin administered during the TAVI achieved through the infusion of a protamine solution until the ACT returns to its baseline level.
Treatment: Antagonization of heparin with protamine sulfate
- No Systematic heparine antagonization with protamine sulphateNo study treatment, for comparison
No administration of protamine solution unless a participant encounters a bleeding event requiring a surgery or percutanous intervention.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Antagonization of Heparin With Protamine Sulfate to Lower All Neurological Ischemic and Hemorrhagic Events After Transcatheter Aortic Valve Implantation for Aortic Stenosis
- Record updated
- 22 August 2025