Comparing routine and selective use of protamine after heart valve surgery
Routine Versus Selective Protamine Administration to Reduce Bleeding Complications After Transcatheter Aortic Valve Implantation
This study is testing whether giving protamine routinely or only when needed after heart valve surgery can help reduce bleeding and save lives in patients undergoing the procedure.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | St. Antonius Hospital Academic / other |
| Locations | 6 sites (Aalst and 5 other locations) |
| Trial ID | NCT05774691 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of routine protamine administration versus selective protamine administration in reducing bleeding complications and cardiovascular mortality within 30 days after transcatheter aortic valve implantation (TAVI). The study will involve patients over 18 years old who are undergoing transfemoral TAVI with any commercially available heart valve. Participants will be monitored for bleeding events and mortality rates to determine the safety and efficacy of the protamine administration approach.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old scheduled for transfemoral TAVI.
Not a fit: Patients with a documented allergy to protamine or those who have had recent PCI may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved safety and reduced bleeding complications for patients undergoing TAVI.
How similar studies have performed: While there is limited high-quality evidence on this specific approach, similar studies have explored protamine use in other contexts, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged \> 18 years * Undergoing transfemoral TAVI with any commercially available transcatheter heart valve * Provided written informed consent Exclusion Criteria: * Documented protamine allergy or anaphylaxis * Recent PCI (\< 3 months before TAVI) * Planned arterial access via surgical cut-down
Where this trial is running
Aalst and 5 other locations
- A.S.Z. Aalst — Aalst, Belgium (Recruiting)
- University Hospitals Leuven — Leuven, Belgium (Recruiting)
- Maastricht UMC — Maastricht, Limburg, Netherlands (Not_yet_recruiting)
- Leiden University Medical Center — Leiden, South Holland, Netherlands (Recruiting)
- St. Antonius Hospital — Nieuwegein, Utrecht, Netherlands (Recruiting)
- Amsterdam University Medical Center — Amsterdam, Netherlands (Not_yet_recruiting)
Study contacts
- Study coordinator: Prof. J.M. ten Berg, MD, PhD
- Email: jurtenberg@gmail.com
- Phone: 0031 088 320 3000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.