Heparin-induced ThrombocytopeniaTIH-FMNCT06066762
Argatroban Monitoring in Acute Suspected Heparin-induced Thrombocytopenia.
An observational study of Heparin-induced Thrombocytopenia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Heparin-induced thrombocytopenia (HIT) is a rare but potentially serious complication of heparin therapy. , argatroban is the alternative anticoagulant of choice in patients with suspected HIT and renal impairment, high bleeding risk or risk of invasive surgery/gesture. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Heparin-induced Thrombocytopenia
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2023to 1 Jun 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 100 years
- All sexes
- Adult, Older adult
Study population: Adult patient with suspected heparin-induced thrombocytopenia and for whom Argatroban is prescribed as part of the treatment.
Who may be able to join
- patients suspected of having HIT in any department, including ECMO in the 10 centers
- patient starting a treatment with argatroban.
- major patients
Who cannot join
- Minor patients
- Patient under legal protection (guardianship or curatorship)
- Patient objecting to re-use of data and samples
Trial locations and contacts
1 site in 1 country.
Dorothée Faille, MD contact
France1 site
Hopital Bichat-Claude Bernard
Paris, 75018
Nadine Ajzenberg, MD, PhD, 01 40 25 62 73, nadine.ajzenberg@aphp.fr
About this study
Official title: Monitoring of Argatroban Anticoagulant Therapy in Patients With Acute Suspected Heparin-induced Thrombocytopenia: French Multicenter Study
Heparin-induced thrombocytopenia (HIT) is a rare but potentially serious complication of heparin therapy. , argatroban is the alternative anticoagulant of choice in patients with suspected HIT and renal impairment, high bleeding risk or risk of invasive surgery/gesture. Despite its increasing use in these fragile patients, methods for biological monitoring of argatroban's anticoagulant activity are heterogeneous, and neither the therapeutic zone nor the modalities for argatroban dosage adjustment are clearly defined, particularly in patients in the acute phase of thrombosis.
Soluble fibrin monomers (FM) indirectly reflect thrombin generation in vivo. This marker could thus represent a new strategy for monitoring the anticoagulant activity of argatroban. However, the effect of argatroban anticoagulation on FM levels remains unknown.
Read more
In a preliminary retrospective study carried out at Bichat hospital, we showed that FM levels could therefore be an early marker of the efficacy of argatroban treatment in patients with suspected HIT.In order to confirm these results, we will include patients with clinico-biological suspicion of HIT and receiving argatroban treatment.
Ten French laboratories will participate in this study. All plasmas collected will be from samples taken only in the context of care.
This prospective study will determine whether the daily monitoring of FM is beneficial for the management of patients treated with argatroban.
Read the detailed description
The study plan to set up a multicenter biobank of plasmas from patients treated with argatroban for suspected HIT in 10 French hematology laboratories (Dijon, Nantes, Tours, Lille, Bordeaux, Nancy, St Etienne, Lariboisière, Rennes, Bichat) that have agreed to participate in this study and have expertise in the management of these patients. All centers adapted the dose of argatroban to its activity, using a test to measure its concentration (TTd or ECT). Some centers adapt the argatroban dose in addition to the anti-IIa activity on FMs, while others do not.
Patient recruitment :
Patients will be recruited over a 1-year period starting in end of 2023. All patients with suspected HIT for whom argatroban therapy is initiated will be included, including patients on ECMO. Plasma from tube ends will be frozen (minimum 2 aliquots of 400 µL) in each center. FMs will be measured daily in centers adapting argatroban dosage to FMs. In other centers, FMs will be measured either daily on fresh plasma or a posteriori on frozen plasmas.
Sampling procedure :
All samples are taken as part of the treatment. No additional tubes will be taken specifically for research purposes.
- D0: A sample will be taken just before starting argatroban, until D-2 before starting argatroban treatment.
- D1: A sample will be taken at least 4 hours after the start of treatment
- D2 to D8: A sample will be taken daily at least 4 hours after any dose change (if applicable)
- D10 and D14: A sample will be taken at least 4 hours after any dose change (if applicable).
In each center: daily plasma storage (2x400 µl minimum) at -80°C.
Analyses performed :
- on fresh whole blood/plasma: blood cell count, aPTT, fibrinogen, anti-IIa activity, D-dimer for all centers. FM for centers1 2 3 (n=50 patients)
- on fresh or frozen plasma: FM for centers 4 5 6 7 8 9 10 (n=50 patients)
- Conditions
- Heparin-induced Thrombocytopenia
- Keywords
- thrombocytopenia, argatroban, fibrin monomers
- Medical subject headings
- Thrombocytopenia
What is being measured
The primary outcome is the main question the study is designed to answer.
Adaptation of the argatroban dose on FM (fibrin monomers) to allow better dose adjustment of Argatroban in patients with suspected HIT
The study will help determine whether this dose adjustment of Argatroban on FM allows an earlier rise of platelets as well as a decrease in thrombotic and/or hemorrhagic events compared to centers that do not use FM.
Measured: 12 days
Secondary outcomes (1)
Determine the therapeutic zone for argatroban, which is not clearly defined to date, based on the following main criteria: FM negativation, correction of thrombocytopenia, absence of thrombotic and hemorrhagic events.
Measured: 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heparin-induced ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadine Ajzenberg, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06066762
- Sponsor's protocol ID
- APHP231085
- Acronym
- TIH-FM
- Status last verified
- Sep 2023
- First submitted
- 28 Sep 2023
- Last updated
- 4 Oct 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 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Argatroban Anticoagulant Therapy in Patients With Acute Suspected Heparin-induced Thrombocytopenia: French Multicenter Study
- ClinicalTrials.gov ID
- NCT06066762
- Acronym / sponsor ID
- TIH-FM / APHP231085
- Conditions
- Heparin-induced Thrombocytopenia
- Keywords
- thrombocytopenia, argatroban, fibrin monomers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 4 Oct 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.
Heparin-induced thrombocytopenia (HIT) is a rare but potentially serious complication of heparin therapy. , argatroban is the alternative anticoagulant of choice in patients with suspected HIT and renal impairment, high bleeding risk or risk of invasive surgery/gesture. Despite its increasing use in these fragile patients, methods for biological monitoring of argatroban's anticoagulant activity are heterogeneous, and neither the therapeutic zone nor the modalities for argatroban dosage adjustment are clearly defined, particularly in patients in the acute phase of thrombosis.
Soluble fibrin monomers (FM) indirectly reflect thrombin generation in vivo. This marker could thus represent a new strategy for monitoring the anticoagulant activity of argatroban. However, the effect of argatroban anticoagulation on FM levels remains unknown.
In a preliminary retrospective study carried out at Bichat hospital, we showed that FM levels could therefore be an early marker of the efficacy of argatroban treatment in patients with suspected HIT.In order to confirm these results, we will include patients with clinico-biological suspicion of HIT and receiving argatroban treatment.
Ten French laboratories will participate in this study. All plasmas collected will be from samples taken only in the context of care.
This prospective study will determine whether the daily monitoring of FM is beneficial for the management of patients treated with argatroban.
Detailed description
The study plan to set up a multicenter biobank of plasmas from patients treated with argatroban for suspected HIT in 10 French hematology laboratories (Dijon, Nantes, Tours, Lille, Bordeaux, Nancy, St Etienne, Lariboisière, Rennes, Bichat) that have agreed to participate in this study and have expertise in the management of these patients. All centers adapted the dose of argatroban to its activity, using a test to measure its concentration (TTd or ECT). Some centers adapt the argatroban dose in addition to the anti-IIa activity on FMs, while others do not.
Patient recruitment :
Patients will be recruited over a 1-year period starting in end of 2023. All patients with suspected HIT for whom argatroban therapy is initiated will be included, including patients on ECMO. Plasma from tube ends will be frozen (minimum 2 aliquots of 400 µL) in each center. FMs will be measured daily in centers adapting argatroban dosage to FMs. In other centers, FMs will be measured either daily on fresh plasma or a posteriori on frozen plasmas.
Sampling procedure :
All samples are taken as part of the treatment. No additional tubes will be taken specifically for research purposes.
- D0: A sample will be taken just before starting argatroban, until D-2 before starting argatroban treatment.
- D1: A sample will be taken at least 4 hours after the start of treatment
- D2 to D8: A sample will be taken daily at least 4 hours after any dose change (if applicable)
- D10 and D14: A sample will be taken at least 4 hours after any dose change (if applicable).
In each center: daily plasma storage (2x400 µl minimum) at -80°C.
Analyses performed :
- on fresh whole blood/plasma: blood cell count, aPTT, fibrinogen, anti-IIa activity, D-dimer for all centers. FM for centers1 2 3 (n=50 patients)
- on fresh or frozen plasma: FM for centers 4 5 6 7 8 9 10 (n=50 patients)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patient with suspected heparin-induced thrombocytopenia and for whom Argatroban is prescribed as part of the treatment.
Key inclusion criteria (3 listed)
- patients suspected of having HIT in any department, including ECMO in the 10 centers
- patient starting a treatment with argatroban.
- major patients
Key exclusion criteria (3 listed)
- Minor patients
- Patient under legal protection (guardianship or curatorship)
- Patient objecting to re-use of data and samples
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
Adaptation of the argatroban dose on FM (fibrin monomers) to allow better dose adjustment of Argatroban in patients with suspected HIT
Time frame: 12 days
The study will help determine whether this dose adjustment of Argatroban on FM allows an earlier rise of platelets as well as a decrease in thrombotic and/or hemorrhagic events compared to centers that do not use FM.
1 secondary outcome
Determine the therapeutic zone for argatroban, which is not clearly defined to date, based on the following main criteria: FM negativation, correction of thrombocytopenia, absence of thrombotic and hemorrhagic events.
Time frame: 12 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
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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.
Dorothée Faille, MD contact
Nadine Ajzenberg, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
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 Heparin-induced Thrombocytopenia, run by Assistance Publique - Hôpitaux de Paris 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 3 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 4 Oct 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 Nadine Ajzenberg, MD, PhD (01 40 25 62 73, nadine.ajzenberg@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adaptation of the argatroban dose on FM (fibrin monomers) to allow better dose adjustment of Argatroban in patients with suspected HIT (time frame: 12 days). 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 4 Oct 2023.