Routine Versus Selective Protamine Administration to Reduce Bleeding Complications After Transcatheter Aortic Valve Implantation

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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 cardiovascular mortality or clinically relevant bleeding within 30 days after transcatheter aortic valve implantation.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Aged \> 18 years

• Undergoing transfemoral TAVI with any commercially available transcatheter heart valve

• Provided written informed consent

Locations
Other Locations
Belgium
A.S.Z. Aalst
RECRUITING
Aalst
University Hospitals Leuven
RECRUITING
Leuven
Netherlands
Amsterdam University Medical Center
NOT_YET_RECRUITING
Amsterdam
Leiden University Medical Center
RECRUITING
Leiden
Maastricht UMC
NOT_YET_RECRUITING
Maastricht
St. Antonius Hospital
RECRUITING
Nieuwegein
Contact Information
Primary
Prof. J.M. ten Berg, MD, PhD
jurtenberg@gmail.com
0031 088 320 3000
Backup
D.C. Overduin, MD
c.overduin@antoniusziekenhuis.nl
0031 088 320 3000
Time Frame
Start Date: 2023-11-01
Estimated Completion Date: 2025-12
Participants
Target number of participants: 1000
Treatments
Active_comparator: Routine protamine administration
Routine protamine administration in a ratio of 1 mg per 100 IU of unfractionated heparin.
Active_comparator: Selective protamine administration
Selective protamine administration, in case of (threatening) bleeding.
Sponsors
Leads: St. Antonius Hospital
Collaborators: St. Antonius Research Fund

This content was sourced from clinicaltrials.gov