Prolonged anticoagulation for preventing blood clots in autoimmune hemolytic anemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of prolonged anticoagulation therapy in preventing venous thromboembolic disease (VTE) in patients diagnosed with autoimmune hemolytic anemia (AIHA). The study is a Phase II, randomized, multicenter trial that aims to assess the incidence of VTE in patients receiving anticoagulation compared to standard treatment. Participants will be monitored for VTE occurrences during the initial high-risk period following their AIHA diagnosis. The trial seeks to establish a potential new preventive strategy for this vulnerable patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient aged ≥ 18 years
* Patient with a diagnosis of primary or secondary autoimmune hemolytic anemia (AIHA) (infections, hematologic diseases, systemic diseases), according to the following criteria:
* Hemoglobin \<12 g/dL
* and decreased haptoglobin (\<0.4 g/L)
* and positive direct antiglobulin test (direct Coombs test) (IgG +/- C3d)
* Patient newly diagnosed or relapse
* Patient with an estimated life expectancy of more than 6 months
* Patient who provided free, written and informed consent

Exclusion Criteria:

* Patients with immediate symptomatic VTE, confirmed by appropriate complementary examinations (venous Doppler of the lower limbs, thoracic angioscanner or pulmonary scintigraphy).
* Patients on curative anticoagulation (venous thromboembolic disease, atrial fibrillation)
* Patient on dual antiaggregation treatment
* Patient with active bleeding
* Patient with a known condition or lesion at risk of bleeding
* Patient with ischemic stroke with hemorrhagic transformation within 6 months prior to inclusion
* Patient on preventive anticoagulation for 14 days or more
* Patient with a contraindication to apixaban:
* Known hypersensitivity to the molecule or to any of the excipients,,
* thrombocytopenia \<100 G/L,
* kidney failure (glomerular filtration rate \< 30 ml/min/1.73m²)
* Active liver disease (liver failure defined as Factor V \<50% or INR \>1.5, ALT elevation \>2 times the upper limit of normal)
* Patients receiving concomitant CYP3A4 inducers (rifampin, phenytoin, carbamazepine, phenobarbital, St. John's Wort) or CYP3A4 inhibitors (azole antifungals, HIV protease inhibitors), if these therapies cannot be discontinued or modified
* Patients with a contraindication to enoxaparin:
* allergy to the drug
* history of heparin-induced thrombocytopenia
* Patient with cold agglutinin-related AHAI (C3d-positive ADT alone with identification of cold agglutinins)
* Patient with severe disorders of hemostasis:
* hypofibrinogenemia \< 2 g/L,
* disseminated intravascular coagulation (APTT prolongation\>1.2, and PT\<50%, and thrombocytopenia\<100 G/L, and D-Dimer \>500 µg/L)
* hemophilia
* Patient whose clinical condition requires hospitalization in an intensive care unit
* Patient who has already participated in the study
* Patient not affiliated to national health insurance
* Patient under legal protection (curatorship, guardianship)
* Patient subject to a measure of legal protection
* Pregnant, parturient or breastfeeding women
* Patient with physiological capacity to procreate (having had her first menstrual period and not menopausal and not presenting permanent sterility (hysterectomy, bilateral salpingectomy, bilateral oophorectomy)) and unable to have effective contraception (i.e., provided by an estrogen-progestin oral contraceptive or progestogen, a contraceptive implant, an intrauterine device or a tubal ligation)
* Patient of legal age who is unable to provide consent

Where it's running

• Chu Dijon Bourgogne
  Dijon, France Recruiting

Study contacts

• Study coordinator: Sylvain AUDIA
• Email: sylvain.audia@chu-dijon.fr
• Phone: 03.80.29.34.32

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• F182112 in relapsed/refractory autoimmune hemolytic anemia

  A small early study tests F182112 as a single treatment for adults with AIHA that has not responded to other therapies, to see if it’s safe and what dose works best.

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• Brain network changes in adults with anemia measured by fNIRS

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• UCAR-T cells targeting CD19 and BCMA for autoimmune blood disorders

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• Reduced‑dose apixaban or rivaroxaban versus daily low‑molecular‑weight heparin for people with blood cancers

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• CM336 treatment for relapsed or refractory autoimmune cytopenia

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  Recruiting at 3 sites Phase 1/2 Keymed Biosciences Co.Ltd · Zhengzhou, Henan and 2 other locations · NCT07175493

• Monitoring adults after venous thromboembolism

  This project tests whether using bleeding-and-recurrence risk scores together with multidisciplinary thrombosis meetings helps guide anticoagulant treatment for adults hospitalized with venous thromboembolism.

  Recruiting University Hospital, Rouen · Rouen · NCT07016542

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.