Primary Haemostasis Disorder in Cardiac Surgery PatientsPLAQUANCT06585930
Relation Between the Value of Platelet Clot Stiffness (PCS) Obtained by Sonorheometric Method of Delocalized Hemostasis (QUANTRA®), and the Presence of a Disorder of Primary Hemostasis, in Cardiac Surgery Patients. PLAQUA-Study
An observational study of Primary Haemostasis Disorder in Cardiac Surgery Patients, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
Trial summary
The goal of this study is to determine whether the Platelet Clot Stiffness (PCS) measured by QUANTRA® is predictive of an abnormality in primary haemostasis intraoperatively in cardiac surgery performed under extracorporeal circulation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Haemostasis Disorder in Cardiac Surgery Patients
- What is being tested?
- Blood sample
- How many people
- 100 participants
- Where
- 1 siteReunion
- Study dates
- 30 Aug 2024to 4 Apr 2025
- Phase
- Observational
- 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
Study population: The patients included in this study were those hospitalized for scheduled cardiac surgery performed under extracorporeal circulation (including coronary bypass, valve replacement, aortic arch and combined surgeries), at the Centre Hospitalier Universiataire de la Réunion, Hopital Félix Guyon.
Who may be able to join
- Patients
- Hospitalized for scheduled cardiac surgery performed under extracorporeal circulation, including coronary bypass, valve replacement, aortic arch and combined surgeries.
Who cannot join
- Patients:
- with preoperative hematocrit < 35% and preoperative platelet count < 80,000 G/L (validity of PFA-200® Test)
- With known congenital or acquired Willebrand's disease, or known platelet dysfunction.
- On double antiaggregation, not discontinued at the time of surgery
- Vulnerable patients: minors or protected adults, pregnant women, patients not affiliated to the social security system.
- Emergency situation
Trial locations and contacts
1 site in 1 country.
Reunion1 site
University Hospital of Reunion Island - Cardiac reanimation department
Saint-Denis, Reunion, 97400
About this study
Official title: Study of the Relationship Between the Value of PCS (Platelet Clot Stiffness - Parameter Evaluating Platelet Participation in Clot Formation) Obtained by Sonorheometric Method of Delocalized Hemostasis (QUANTRA®), and the Presence of a Disorder of Primary Hemostasis, in Cardiac Surgery Patients. PLAQUA-Study
The goal of this study is to determine whether the Platelet Clot Stiffness (PCS) measured by QUANTRA® is predictive of an abnormality in primary haemostasis intraoperatively in cardiac surgery performed under extracorporeal circulation.
The aim is to compare the assessment of platelet function by QUANTRA® (data called PCS, obtained in around ten minutes) with laboratory tests which are validated, but which cannot be used in current practice (response time too long, in particular). We are therefore seeking to determine whether QUANTRA is reliable in the search for a primary hemostasis anomaly, defined by significant thrombocytopenia (platelet count below 100G/L), and/or a prolongation of platelet occlusion time measured by PFA-200® (normal or increased).
Read more
This clinical research project will last 12 months. It will take place in the cardiac surgery operating room at CHU Félix Guyon, and will involve 100 patients.
Patients who have consented to participate in this research project will be managed in the operating room in the usual way, with no change to their usual care (in terms of treatments received). At the end of the surgery, we will add 3 blood samples (maximum 8.1ml) for analysis to assess platelet function and compare with QUANTRA data.
This blood sample will be the only procedure performed. Medical management remains standard and will not be disrupted by this test.
- Being tested
- Blood sample
- Keywords
- Primary haemostasis disorder, Platelet Clot Stiffness, QUANTRA, von Willebrand factor deficiency
- Medical subject headings
- Von willebrand factor, deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleBiological
Additional 8.1 ml blood sample
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of a primary haemostasis disorder
Significant thrombocytopenia (platelet count below 100G/L), and/or prolonged platelet occlusion time measured by PFA-200® (normal or increased), depending on the PCS value obtained by QUANTRA®.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start30 Aug 2024
- Primary completion4 Apr 2025
- Study completion4 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Haemostasis Disorder in Cardiac Surgery PatientsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Margot CARON, Dr, Principal investigator, University Hospital of Reunion Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06585930
- Sponsor's protocol ID
- 2024-A01342-45
- Acronym
- PLAQUA
- Status last verified
- May 2025
- First submitted
- 28 Aug 2024
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Relationship Between the Value of PCS (Platelet Clot Stiffness - Parameter Evaluating Platelet Participation in Clot Formation) Obtained by Sonorheometric Method of Delocalized Hemostasis (QUANTRA®), and the Presence of a Disorder of Primary Hemostasis, in Cardiac Surgery Patients. PLAQUA-Study
- ClinicalTrials.gov ID
- NCT06585930
- Acronym / sponsor ID
- PLAQUA / 2024-A01342-45
- Keywords
- Primary haemostasis disorder, Platelet Clot Stiffness, QUANTRA, von Willebrand factor deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 30 Aug 2024 (actual)
- Primary completion
- 4 Apr 2025 (actual)
- Study completion
- 4 Apr 2025 (actual)
- First posted
- 19 Sep 2024 (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.
The goal of this study is to determine whether the Platelet Clot Stiffness (PCS) measured by QUANTRA® is predictive of an abnormality in primary haemostasis intraoperatively in cardiac surgery performed under extracorporeal circulation.
The aim is to compare the assessment of platelet function by QUANTRA® (data called PCS, obtained in around ten minutes) with laboratory tests which are validated, but which cannot be used in current practice (response time too long, in particular). We are therefore seeking to determine whether QUANTRA is reliable in the search for a primary hemostasis anomaly, defined by significant thrombocytopenia (platelet count below 100G/L), and/or a prolongation of platelet occlusion time measured by PFA-200® (normal or increased).
This clinical research project will last 12 months. It will take place in the cardiac surgery operating room at CHU Félix Guyon, and will involve 100 patients.
Patients who have consented to participate in this research project will be managed in the operating room in the usual way, with no change to their usual care (in terms of treatments received). At the end of the surgery, we will add 3 blood samples (maximum 8.1ml) for analysis to assess platelet function and compare with QUANTRA data.
This blood sample will be the only procedure performed. Medical management remains standard and will not be disrupted by this test.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients included in this study were those hospitalized for scheduled cardiac surgery performed under extracorporeal circulation (including coronary bypass, valve replacement, aortic arch and combined surgeries), at the Centre Hospitalier Universiataire de la Réunion, Hopital Félix Guyon.
Key inclusion criteria (2 listed)
- Patients
- Hospitalized for scheduled cardiac surgery performed under extracorporeal circulation, including coronary bypass, valve replacement, aortic arch and combined surgeries.
Key exclusion criteria (6 listed)
- with preoperative hematocrit < 35% and preoperative platelet count < 80,000 G/L (validity of PFA-200® Test)
- With known congenital or acquired Willebrand's disease, or known platelet dysfunction.
- On double antiaggregation, not discontinued at the time of surgery
- Vulnerable patients: minors or protected adults, pregnant women, patients not affiliated to the social security system.
- Emergency situation
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 |
|---|---|---|
| Blood sampleAdditional 8.1 ml blood sample | Biological | – |
Primary outcome
Presence of a primary haemostasis disorder
Time frame: Two years
Significant thrombocytopenia (platelet count below 100G/L), and/or prolonged platelet occlusion time measured by PFA-200® (normal or increased), depending on the PCS value obtained by QUANTRA®.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Individual participant dataSharing planned: No
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.
Margot CARON, Dr principal investigator
University Hospital of Reunion Island
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Haemostasis Disorder in Cardiac Surgery Patients, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
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 6 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: finished, as of the sponsor's last update on 29 May 2025. 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 Reunion. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of a primary haemostasis disorder (time frame: Two years). 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 29 May 2025.