Blood Coagulation DisorderNCT06582563
Evaluation of Clinical Ranges of Whole Blood Clotting Times of Patients on Anticoagulants
An observational study of Blood Coagulation Disorder, run by Perosphere Technologies Inc. at 1 site in Belgium.
Trial summary
Whole blood clotting time measurements are to collect the clotting time ranges for DOAC-anticoagulated patients and assess their correlation with plasma drug levels (via anti-FXa assay). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Blood Coagulation Disorder
- What is being tested?
- Whole Blood Clotting Time
- How many people
- 120 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2025to 30 Aug 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated with rivaroxaban, apixaban, or edoxaban between the ages of 18 and 80 years old. A sufficient number (12 or above) of the patients are above 70 years of age.
Who may be able to join
- In general, study participants must:
- Be informed of the nature of the study and provide written informed consent before any study-specific procedures are performed.
- Be 18- to 80-years-of-age, inclusive, at time of consent.
- Have suitable venous access for at least a single venipuncture.
- Eligible patients on anticoagulants must have taken their prescribed anticoagulant regularly at least for one month prior to study participation for inclusion
Who cannot join
- Eligible patients on anticoagulants must not:
- Other than the condition for which a DOAC was prescribed , have a personal or family history of clotting disorder or hematologic abnormality, such as excessive bleeding, joint hematoma, thrombovascular disease, thrombocytopenia, or any chronic condition requiring treatment with transfusions.
- Have a BMI> 40 or weight > 120kg.
- Suffer from renal or hepatic insufficiency.
- Suffer from any pathology that would contra-indicate in general DOAC medication.
- Have a history of unexplained syncope.
Show all 10Show fewer
- Have a history within 6 months prior to Screening of peptic ulcer or gastrointestinal bleeding (including hematemesis, melena, or rectal bleeding).
- Consume more than 5 cigarettes per day.
- If female, have a history of excessive or dysfunctional uterine bleeding (unless the subject had a subsequent hysterectomy).
- If female is pregnant, breastfeeding, or planning to become pregnant during study
Trial locations and contacts
1 site in 1 country.
Belgium1 site
UZ Leuven Hospital
Leuven
Peter Verhamme, Professor, 3216343491, peter.verhamme@uzleuven.be
Sasha Bakhru, PhD, s.bakhru@perospheretech.com
About this study
Official title: Study for Evaluation of Clinical Ranges of Whole Blood Clotting Times
Whole blood clotting time measurements are to collect the clotting time ranges for DOAC-anticoagulated patients and assess their correlation with plasma drug levels (via anti-FXa assay).
Read the detailed description
Primary objectives of the planned whole blood clotting time measurements are to collect the clotting time ranges for DOAC-anticoagulated patients and assess their correlation with plasma drug levels (via anti-FXa assay).
- Conditions
- Blood Coagulation Disorder
- Being tested
- Whole Blood Clotting Time
- Medical subject headings
- Blood Coagulation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Blood Clotting TimeDiagnostic test
Comparator
What is being measured
The primary outcome is the main question the study is designed to answer.
Clotting times of whole blood samples, measured on Perosphere Technologies' PoC Coagulometer devices
Whole Blood Clotting Time
Measured: Immediate
Secondary outcomes (1)
Drug concentrations in collected blood samples as measured through anti-factor Xa (anti-Xa) assay
Drug concentration measurements
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start1 Mar 2025 (estimated)
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Coagulation DisorderStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Perosphere Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06582563
- Sponsor's protocol ID
- CP-01-02-002
- Status last verified
- Oct 2024
- First submitted
- 21 Aug 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study for Evaluation of Clinical Ranges of Whole Blood Clotting Times
- ClinicalTrials.gov ID
- NCT06582563
- Acronym / sponsor ID
- CP-01-02-002
- Conditions
- Blood Coagulation Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Perosphere Technologies Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 3 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.
Whole blood clotting time measurements are to collect the clotting time ranges for DOAC-anticoagulated patients and assess their correlation with plasma drug levels (via anti-FXa assay).
Detailed description
Primary objectives of the planned whole blood clotting time measurements are to collect the clotting time ranges for DOAC-anticoagulated patients and assess their correlation with plasma drug levels (via anti-FXa assay).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with rivaroxaban, apixaban, or edoxaban between the ages of 18 and 80 years old. A sufficient number (12 or above) of the patients are above 70 years of age.
Key inclusion criteria (5 listed)
- In general, study participants must:
Key exclusion criteria (10 listed)
- Eligible patients on anticoagulants must not:
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 |
|---|---|---|
| Whole Blood Clotting TimeComparator | Diagnostic test | – |
Primary outcome
Clotting times of whole blood samples, measured on Perosphere Technologies' PoC Coagulometer devices
Time frame: Immediate
Whole Blood Clotting Time
1 secondary outcome
Drug concentrations in collected blood samples as measured through anti-factor Xa (anti-Xa) assay
Time frame: Immediate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Blood Coagulation Disorder
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
Active, not recruitingObservational study
An Observational Study of Participants With Type 3 Von Willebrand Disease on Prophylactic Standard-of-Care Treatment
Von Willebrand Disease, Type 3
RecruitingPhase 2
A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)
Primary Immune Thrombocytopenia (ITP), Primary Evans Syndrome (ES)
Active, not recruitingObservational study
A Study to Learn About the Study Medicine -Hympavzi in Congenital Hemophilia Patients Without Inhibitors in Japan.
Hemophilia A or B
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?
An observational study of Blood Coagulation Disorder, run by Perosphere Technologies Inc. at 1 site in Belgium.
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 5 inclusion and 10 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 8 Oct 2024. 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 Belgium. 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 Peter Verhamme, Professor (3216343491, peter.verhamme@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clotting times of whole blood samples, measured on Perosphere Technologies' PoC Coagulometer devices (time frame: Immediate). 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 8 Oct 2024.