None listed
Conditions
Brief summary
In patients with diseased aortic valves, catheter-based replacement of the sick valve (TAVI) is a less invasive alternative for surgical valve replacement. TAVI has become the procedure of first choice in patients with increased operative risk. Because the valve is implanted through a catheter from the groin, there is no need for open heart surgery and recovery is much quicker. However, there remains a risk of major or life-threatening bleeding from the access site, especially because patients require blood-thinners (heparin) during the valve implantation. At the end of the procedure, when blood-thinners are no longer required, the effect of heparin can be reversed by protamine injection, but routine use of protamine has not been tested in TAVI patients in a randomised trial. In this study we will evaluate if routine use of protamine reduces the risk of major bleeding and improves outcomes for patients who underwent TAVI. We will compare safety and effectiveness of routine use of protamine in a randomised controlled trial and will compare outcomes after 30 days. The results of this study will help to improve the safety of the TAVI procedure and its outcomes for patient (reduced morbidity and mortality) and society (reduced demand on constrained economic resources).
Interventions
The investigational treatment will be one dose of protamine IV in a 0.6-1.0 ratio of 1mg per 100IU of heparin.
Two 10cc syringes, one with protamine (10mg/mL) and one placebo (10mL NaCl 0.9%) will be prepared by either the anaesthetics team or the nursing staff. Dependent on outcome of randomisation, one syringe will be labelled with ‘A’ and contains protamine, and the other will be labelled ‘B’ and contains placebo, or vice versa. This will be documented, and primary operators will be blinded
The investigational treatment will be one dose of protamine IV in a 0.6-1.0 ratio of 1mg per 100IU of heparin. Two 10cc syringes, one with protamine (10mg/mL) and one placebo (10mL NaCl 0.9%) will be prepared by either the anaesthetics team or the nursing staff. Dependent on outcome of randomisation, one syringe will be labelled with ‘A’ and contains protamine, and the other will be labelled ‘B’ and contains placebo, or vice versa. This will be documented, and primary operators will be blinded to the true contents of syringe A and B. Prior to removal of the large sheath, ACT will be assessed. Then syringe A will be injected and sheath-removal/arteriotomy closure per operator’s discretion will be performed. If haemostasis is achieved, time between sheath removal and confirmed arterial haemostasis will be recorded. If after 10 minutes no haemostasis is achieved, syringe B may be injected per operator’s request.
Sponsors
Antony Walton
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants eligible for inclusion in this study are: - aged 18 years or older. - undergoing elective trans-femoral TAVI with any commercially available transcatheter heart valve.
Exclusion criteria
Participants not eligible for inclusion in this study are: - Documented protamine allergy or anaphylaxis - Recent PCI (< 3 months) - Planned arterial access via surgical cut-down - Pregnancy
Outcome results
None listed