Blood thinner breakthrough could stop clots in rare anemia
NCT ID NCT05089227
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether taking blood thinners for 12 weeks can prevent dangerous blood clots in people with autoimmune hemolytic anemia (AIHA), a rare disease where the immune system destroys red blood cells. About 72 adults with newly diagnosed or relapsed AIHA will receive either standard care or extended blood-thinner treatment. The goal is to see if longer prevention reduces the high risk of clots during the first three months after diagnosis or relapse.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 72 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2022
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Chu Dijon Bourgogne
RECRUITINGDijon, 21000, France
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