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Routine Versus Selective Protamine Administration to Reduce Bleeding Complications After Transcatheter Aortic Valve Implantation (POPular ACE TAVI)

Primary Purpose

Aortic Valve Stenosis

Status
Not yet recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Protamine sulfate
Protamine sulfate
Sponsored by
St. Antonius Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Aortic Valve Stenosis focused on measuring TAVI, TAVR, Bleeding, Mortality, Allergy, Protamine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 Pregnancy

Sites / Locations

  • A.S.Z. Aalst
  • University Hospitals Leuven
  • Maastricht UMC
  • Leiden University Medical Center
  • St. Antonius Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Routine protamine administration

Selective protamine administration

Arm Description

Routine protamine administration in a ratio of 1 mg per 100 IU of unfractionated heparin.

Selective protamine administration, in case of (threatening) bleeding.

Outcomes

Primary Outcome Measures

Composite of cardiovascular mortality or type 1-4 bleeding
According to the VARC-3 criteria

Secondary Outcome Measures

Haemoglobin level
mmol/L
Procedural haemostasis failure
Failure to achieve haemostasis at the arteriotomy site leading to alternative treatment (e.g. fem-stop device, or adjunctive endovascular ballooning/stenting)
Delayed haemostasis failure
The occurrence of bleeding requiring prolonged manual compression or alternative interventions (new pressure bandage, fem-stop device, endovascular or surgical repair) after initial haemostasis was achieved and patient is no longer in the cathlab.
Length of post-procedural stay
Post-procedural length of stay will be measured in the time (days) from procedure to discharge
Need for transfusion
Any bleeding requiring transfusion of 1 or more units of whole blood/RBC
All bleeding
According to the VARC-3 criteria type 1-4 bleeding
Major, life-threatening or fatal bleeding
According to the VARC-3 criteria type 2-4 bleeding
Major vascular complications
According to the VARC-3 criteria
Cardiovascular mortality
According to the VARC-3 criteria
All-cause mortality
According to the VARC-3 criteria

Full Information

First Posted
March 3, 2023
Last Updated
September 4, 2023
Sponsor
St. Antonius Hospital
Collaborators
St. Antonius Research Fund
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1. Study Identification

Unique Protocol Identification Number
NCT05774691
Brief Title
Routine Versus Selective Protamine Administration to Reduce Bleeding Complications After Transcatheter Aortic Valve Implantation (POPular ACE TAVI)
Official Title
Routine Versus Selective Protamine Administration to Reduce Bleeding Complications After Transcatheter Aortic Valve Implantation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 15, 2023 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Antonius Hospital
Collaborators
St. Antonius Research Fund

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 bleeding within 30 days after transcatheter aortic valve implantation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis
Keywords
TAVI, TAVR, Bleeding, Mortality, Allergy, Protamine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Routine protamine administration
Arm Type
Active Comparator
Arm Description
Routine protamine administration in a ratio of 1 mg per 100 IU of unfractionated heparin.
Arm Title
Selective protamine administration
Arm Type
Active Comparator
Arm Description
Selective protamine administration, in case of (threatening) bleeding.
Intervention Type
Drug
Intervention Name(s)
Protamine sulfate
Other Intervention Name(s)
Routine heparin reversal
Intervention Description
Routine protamine administration in a ratio of 1 mg per 100 IU of unfractionated heparin
Intervention Type
Drug
Intervention Name(s)
Protamine sulfate
Other Intervention Name(s)
Selective heparin reversal
Intervention Description
Selective protamine administration, in case of (threatening) bleeding
Primary Outcome Measure Information:
Title
Composite of cardiovascular mortality or type 1-4 bleeding
Description
According to the VARC-3 criteria
Time Frame
30 days after TAVI
Secondary Outcome Measure Information:
Title
Haemoglobin level
Description
mmol/L
Time Frame
30 days after TAVI
Title
Procedural haemostasis failure
Description
Failure to achieve haemostasis at the arteriotomy site leading to alternative treatment (e.g. fem-stop device, or adjunctive endovascular ballooning/stenting)
Time Frame
30 days after TAVI
Title
Delayed haemostasis failure
Description
The occurrence of bleeding requiring prolonged manual compression or alternative interventions (new pressure bandage, fem-stop device, endovascular or surgical repair) after initial haemostasis was achieved and patient is no longer in the cathlab.
Time Frame
30 days after TAVI
Title
Length of post-procedural stay
Description
Post-procedural length of stay will be measured in the time (days) from procedure to discharge
Time Frame
30 days after TAVI
Title
Need for transfusion
Description
Any bleeding requiring transfusion of 1 or more units of whole blood/RBC
Time Frame
30 days after TAVI
Title
All bleeding
Description
According to the VARC-3 criteria type 1-4 bleeding
Time Frame
30 days after TAVI
Title
Major, life-threatening or fatal bleeding
Description
According to the VARC-3 criteria type 2-4 bleeding
Time Frame
30 days after TAVI
Title
Major vascular complications
Description
According to the VARC-3 criteria
Time Frame
30 days after TAVI
Title
Cardiovascular mortality
Description
According to the VARC-3 criteria
Time Frame
30 days after TAVI
Title
All-cause mortality
Description
According to the VARC-3 criteria
Time Frame
30 days after TAVI
Other Pre-specified Outcome Measures:
Title
Anaphylaxis
Description
According to the National Institute of Allergy and Infectious Disease criteria
Time Frame
30 days after TAVI
Title
Thromboembolic events
Description
Composite of myocardial infarction, ischaemic stroke, transient ischaemic attack or non-cerebral distal embolization according to the VARC-3 criteria
Time Frame
30 days after TAVI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
V.J. Nijenhuis, MD, PhD
Phone
+31(0)88 320 12 37
Email
v.nijenhuis@antoniusziekenhuis.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Prof. J.M. ten Berg, MD, PhD, MSc
Email
jurtenberg@gmail.com
Facility Information:
Facility Name
A.S.Z. Aalst
City
Aalst
Country
Belgium
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. L. Rosseel, MD, PhD
Facility Name
University Hospitals Leuven
City
Leuven
Country
Belgium
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prof. C. Dubois, MD, PhD
Facility Name
Maastricht UMC
City
Maastricht
State/Province
Limburg
Country
Netherlands
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. P. Vriesendorp, MD, PhD
Facility Name
Leiden University Medical Center
City
Leiden
State/Province
South Holland
Country
Netherlands
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Drs. J. Montero- Cabezas, MD
First Name & Middle Initial & Last Name & Degree
Drs. F. van der Kley, MD
Facility Name
St. Antonius Hospital
City
Nieuwegein
State/Province
Utrecht
Country
Netherlands
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prof. J.M. ten Berg, MD, PhD, MSc

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Routine Versus Selective Protamine Administration to Reduce Bleeding Complications After Transcatheter Aortic Valve Implantation (POPular ACE TAVI)

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