Transcatheter Aortic Valve ReplacementADAPTNCT05259241
ADAPT Transcatheter Aortic Valve Intervention (TAVI & Chronic Total Occlusion Percutaneous Coronary Intervention (CTO PCI)
A study testing activated partial thrombin time in people with Transcatheter Aortic Valve Replacement and Percutaneous Coronary Intervention, run by Erasmus Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transcatheter Aortic Valve Replacement, Percutaneous Coronary Intervention
- What is being tested?
- activated partial thrombin time
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteNetherlands
- Study dates
- 20 Oct 2020to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients undergoing a TAVI-procedure
- All patients undergoing a CTO PCI procedure
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus University Medical Center
Rotterdam, South Holland, 3015GD
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- activated partial thrombin time
- Keywords
- ACT, APTT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
activated partial thrombin timeDiagnostic test
Also called activated clotting 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)
| Study group | Role | What they receive |
|---|---|---|
| Single arm study | Other | 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 Receives: Diagnostic Test: activated partial thrombin time |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 minutes after heparin bolus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start20 Oct 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcatheter Aortic Valve ReplacementStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-center, prospective, observational study
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Responsible party
- Principal investigator, Nicolas van Mieghem, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05259241
- Sponsor's protocol ID
- MEC-2020-0375
- Acronym
- ADAPT
- Status last verified
- Jul 2022
- First submitted
- 21 Sep 2021
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between ACT anD APTT During Transcatheter Aortic Valve Implantation and Chronic Total Occlusion Percutaneous Coronary Interventions
- ClinicalTrials.gov ID
- NCT05259241
- Acronym / sponsor ID
- ADAPT / MEC-2020-0375
- Keywords
- ACT, APTT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 28 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-center, prospective, observational study
| Arm | Type | Receives |
|---|---|---|
| Single arm study | Other | Diagnostic Test: activated partial thrombin timeCohort 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients undergoing a TAVI-procedure
- All patients undergoing a CTO PCI procedure
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| activated partial thrombin timeAlso: activated clotting timeThis 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) | Diagnostic test | Single arm study |
Primary outcome
The correlation between the ACT point-of-care test with the Anti-Xa-activity measurement).
Time frame: 30 minutes after heparin bolus
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.
The correlation between the APTT point-of-care test with the coagulation status(Anti-Xa-measurement).
Time frame: 30 minutes after heparin bolus
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing activated partial thrombin time in people with Transcatheter Aortic Valve Replacement and Percutaneous Coronary Intervention, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicolas Van Mieghem, MD, PhD (+31 10 703 52 60, n.vanmieghem@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The correlation between the ACT point-of-care test with the Anti-Xa-activity measurement). (time frame: 30 minutes after heparin bolus). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022.