ThrombophiliaDOAC-StopNCT06171984
Thrombophilia Assessment Under DOAC: Effectiveness of Activated Charcoal
An observational study of Thrombophilia, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Direct oral anticoagulants (DOAC) are anticoagulant molecules that act either directly on factor Xa (Apixaban, Rivaroxaban) or on factor IIa (Dabigatran). AODs interfere with most coagulation tests, especially those performed by chronometric technique. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombophilia
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jul 2022to 19 Jan 2024
- 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
- Adult, Older adult
Study population: Adult subject (≥ 18 years of age) with blood sample already analyzed in a usual way in the laboratory of HUS as part of the care
Who may be able to join
- Adult subject (≥ 18 years of age)
- Blood sample already analyzed in a usual way in the laboratory as part of the care
- Subject not objecting to the reuse of his or her medical data for scientific research purposes.
Who cannot join
- Insufficient sample
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Laboratoire d'Hématologie - CHU de Strasbourg - France
Strasbourg, 67091
Agathe HERB, PharmD
Agathe HERB, PharmD
About this study
Official title: Thrombophilia Assessment Under Direct Oral Anticoagulants (DOAC): Efficacy of Activated Charcoal
Direct oral anticoagulants (DOAC) are anticoagulant molecules that act either directly on factor Xa (Apixaban, Rivaroxaban) or on factor IIa (Dabigatran).
AODs interfere with most coagulation tests, especially those performed by chronometric technique.
For this reason, part of the thrombophilia workup (protein S, search for lupus anticoagulants, antithrombin for patients on dabigatran) cannot be performed on DOACs at the HUS.
Recent studies have highlighted the effectiveness of activated charcoal to adsorb DOACs in order to perform certain hemostasis tests.
- Conditions
- Thrombophilia
- Keywords
- Thrombophilia, direct oral anticoagulants, DOAC, Apixaban, Rivaroxaban, Dabigatran, Hemostasis tests
- Medical subject headings
- Thrombophilia
What is being measured
The primary outcome is the main question the study is designed to answer.
Interference or not of activated charcoal in the measurement of protein S, antithrombin, and in the search for lupus anticoagulants.
This study compares the results of two diagnostic techniques (Thrombophilia work-up under direct oral anticoagulants (DOACs)), one using activated charcoal versus another not using it
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start19 Jul 2022
- Primary completionJan 2024 (estimated)
- Study completion19 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombophiliaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06171984
- Sponsor's protocol ID
- 8673
- Acronym
- DOAC-Stop
- Status last verified
- Dec 2023
- First submitted
- 6 Sep 2022
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thrombophilia Assessment Under Direct Oral Anticoagulants (DOAC): Efficacy of Activated Charcoal
- ClinicalTrials.gov ID
- NCT06171984
- Acronym / sponsor ID
- DOAC-Stop / 8673
- Conditions
- Thrombophilia
- Keywords
- Thrombophilia, direct oral anticoagulants, DOAC, Apixaban, Rivaroxaban, Dabigatran, Hemostasis tests
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 19 Jul 2022 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- 19 Jan 2024 (estimated)
- First posted
- 15 Dec 2023 (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.
Direct oral anticoagulants (DOAC) are anticoagulant molecules that act either directly on factor Xa (Apixaban, Rivaroxaban) or on factor IIa (Dabigatran).
AODs interfere with most coagulation tests, especially those performed by chronometric technique.
For this reason, part of the thrombophilia workup (protein S, search for lupus anticoagulants, antithrombin for patients on dabigatran) cannot be performed on DOACs at the HUS.
Recent studies have highlighted the effectiveness of activated charcoal to adsorb DOACs in order to perform certain hemostasis tests.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult subject (≥ 18 years of age) with blood sample already analyzed in a usual way in the laboratory of HUS as part of the care
Key inclusion criteria (3 listed)
- Adult subject (≥ 18 years of age)
- Blood sample already analyzed in a usual way in the laboratory as part of the care
- Subject not objecting to the reuse of his or her medical data for scientific research purposes.
Key exclusion criteria (1 listed)
- Insufficient sample
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Interference or not of activated charcoal in the measurement of protein S, antithrombin, and in the search for lupus anticoagulants.
Time frame: Through study completion, an average of 6 months
This study compares the results of two diagnostic techniques (Thrombophilia work-up under direct oral anticoagulants (DOACs)), one using activated charcoal versus another not using it
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
Related trials for Thrombophilia
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Sepsis, Sepsis-induced Coagulopathy
Not yet recruiting
Safflower (Carthamus Tinctorius L.) Granules for Sepsis-associated Coagulopathy
Sepsis, Disseminated Intravascular Coagulation (DIC)
Not yet recruitingObservational study
MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
Antiphospholipid (aPL)-Positive, Rheumatic Arthritis
RecruitingObservational study
A Study to Learn More About the Treatment of People With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Who Received Recombinant ADAMTS13 (rADAMTS13) as Part of the Early Access Program
Thrombotic Thrombocytopenic Purpura (TTP)
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 Thrombophilia, run by University Hospital, Strasbourg, France at 1 site in France.
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 3 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 15 Dec 2023. 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 France. 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 Agathe HERB, PharmD (33 3 88 12 75 53, agathe.herb@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interference or not of activated charcoal in the measurement of protein S, antithrombin, and in the search for lupus anticoagulants. (time frame: Through study completion, an average of 6 months). 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 15 Dec 2023.