ADAPT Transcatheter Aortic Valve Intervention (TAVI & Chronic Total Occlusion Percutaneous Coronary Intervention (CTO PCI)

NCT ID: NCT05259241

Last Updated: 2022-07-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-20
• Study Completion Date: 2023-01-01

Brief Summary

Rationale: The choice of antithrombotic regimen during TAVI and CTO PCI includes the use of unfractionated heparin. The accuracy of ACT in this setting is disputed. ACT has never been compared to a point-of-care aPTT test for monitoring anticoagulation during percutaneous cardiac interventions.

Objective: The aim of the present study is to evaluate which point-of-care test (ACT or aPTT) gives the best correlation with the coagulation status in patients, defined with the anti-Xa measurement.

Study design: A Single-center, prospective, observational study Study population: patients undergoing TAVI (Cohort A) or CTO PCI (Cohort B) in the Erasmus University Medical Center

Main study parameters/endpoints: The main study endpoints are the correlation between the ACT and APTT point-of-care- tests and the coagulation status, defined as the laboratory anti-Xa measurement.

Detailed Description

The choice of antithrombotic regimen during TAVI and CTO PCI includes the use of unfractionated heparin. Heparin is the preferred anticoagulant drug in these percutaneous cardiac interventions aiming for an Activated Clotting Time (ACT) > 200sec or 250seconds depending on the procedure. Heparin has a short half-life time and can be neutralized by protamine.

Monitoring the use of unfractionated heparin during TAVI and PCI can be performed with several measurements, like the ACT and aPTT. To measure ACT, an activator is mixed with whole blood to provide a timing of haemostasis. aPTT is a plasma test in which a surface activator is used to measure the time it takes to form a fibrin clot. In nearly every center ACT is the preferred method because of its ease of use and the assumed reliability. ACT-guided heparin regime during TAVI seems effective in minimizing major bleeding events.

There are limited studies focussing on the difference between ACT- and aPTT measurements. The studies which investigated this difference are merely done in patients with continuous heparin infusions, for example in the setting of extracorporeal membrane oxygenation(ECMO). These studies suggest that there is a better correlation between aPTT and dosage heparin than between ACT and heparin. Also, the correlation between ACT and aPTT seems poor.

The accuracy and correlation of ACT with a point-of-care aPTT test for monitoring the anticoagulation effect of unfractionated heparin has so far not been done in the setting of percutaneous interventions. TAVI requires large bore arterial access and is associated with a relevant frequency of access site related bleeding and vascular complications. CTO procedures often require dual arterial access and the use of different strategies with multiple wires which increases the prevalence of vascular complications, including pericardial effusion.

Precise knowledge of actual anticoagulation status during an invasive procedure and at the time of access site closure may affect the incidence of TAVI and CTO PCI related bleeding complications.

Therefore, the aim of the present study is to evaluate which point-of-care test (ACT or aPTT) gives the best correlation with the coagulation status in patients during TAVI and CTO PCI.

Conditions

Transcatheter Aortic Valve Replacement; Percutaneous Coronary Intervention

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Single arm study

Cohort A: patients undergoing TAVR to evaluate which point-of-care test (ACT or aPTT) gives the best correlation with the coagulation status

Cohort B: patients undergoing PCI to evaluate which point-of-care test (ACT or aPTT) gives the best correlation with the coagulation status

Group Type: OTHER

activated partial thrombin time

Intervention Type: DIAGNOSTIC_TEST

This study aims to find which the point-of-care test (ACT or APTT) has the best correlation with the coagulation status during transcatheter cardiac interventions (either TAVR or PCI)

Interventions

activated partial thrombin time

This study aims to find which the point-of-care test (ACT or APTT) has the best correlation with the coagulation status during transcatheter cardiac interventions (either TAVR or PCI)

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

activated clotting time

Eligibility Criteria

Inclusion Criteria

• All patients undergoing a TAVI-procedure
• All patients undergoing a CTO PCI procedure

Exclusion Criteria

• none

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roche Diagnostics GmbH

INDUSTRY

Sponsor Role: collaborator

Erasmus Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Nicolas van Mieghem

Clinical director of Interventional cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Erasmus University Medical Center

Rotterdam, South Holland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Nicolas Van Mieghem, MD, PhD

Role: CONTACT

n.vanmieghem@erasmusmc.nl

+31 10 703 52 60

Thijmen Hokken, MD

Role: CONTACT

t.hokken@erasmusmc.nl

+31107038896

Other Identifiers

MEC-2020-0375

Identifier Type: -

Identifier Source: org_study_id