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

Correlation Between ACT anD APTT During Transcatheter Aortic Valve Implantation and Chronic Total Occlusion Percutaneous Coronary Interventions

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.

Study Overview

• Status: Recruiting
• Conditions: Transcatheter Aortic Valve Replacement; Percutaneous Coronary Intervention
• Intervention / Treatment: Diagnostic test: activated partial thrombin time

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicolas Van Mieghem, MD, PhD; Phone Number: +31 10 703 52 60; Email: n.vanmieghem@erasmusmc.nl

Study Locations

• Netherlands
  • Zuid Holland
    • Rotterdam, Zuid Holland, Netherlands, 3015GD
      • Recruiting
      • Erasmus University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	Diagnostic test: 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); Other Names: activated clotting time

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The correlation between the ACT point-of-care test with the Anti-Xa-activity measurement).	The anti-Xa-measurement(in IU/mL) is defined as the reference for the coagulation status. In this study, we measure the point-of-care ACT measurement(in milliseconds) and the anti-Xa measurement 30 minutes after the heparin bolus to determine the correlation.	30 minutes after heparin bolus
The correlation between the APTT point-of-care test with the coagulation status(Anti-Xa-measurement).	The anti-Xa-measurement(in IU/mL) is defined as the reference for the coagulation status. In this study, we measure the point-of-care APTT measurement(in milliseconds) and the anti-Xa measurement 30 minutes after the heparin bolus to determine the correlation.	30 minutes after heparin bolus

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Collaborators: Roche Diagnostics

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2020
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: September 21, 2021
• First Submitted That Met QC Criteria: February 18, 2022
• First Posted (Actual): February 28, 2022

Study Record Updates

• Last Update Posted (Actual): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 25, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: ACT; APTT
• Additional Relevant MeSH Terms: Hemostatics; Coagulants; Thrombin
• Other Study ID Numbers: MEC-2020-0375

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No