Prolonged anticoagulation for preventing blood clots in autoimmune hemolytic anemia

Efficacy of Prolonged Anticoagulation for Primary Prevention of Venous Thromboembolic Disease in Autoimmune Hemolytic Anemia: a Prospective, Phase II, Randomized, Multicenter Study

This study is testing if longer use of blood thinners can help prevent blood clots in people with autoimmune hemolytic anemia.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Universitaire Dijon (Academic / other)
• Locations: 1 site (Dijon)
• Trial ID: NCT05089227 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with a diagnosis of primary or secondary autoimmune hemolytic anemia and specific laboratory criteria.

Not a fit: Patients who have experienced immediate symptomatic venous thromboembolism or are on curative anticoagulation will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the incidence of blood clots in patients with autoimmune hemolytic anemia.

How similar studies have performed: While the approach of using anticoagulation in this specific patient population is novel, similar studies in other high-risk groups have shown promising results.

Eligibility criteria

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 this trial is running

Dijon

• Chu Dijon Bourgogne — Dijon, France (Recruiting)

Study contacts

• Study coordinator: Sylvain AUDIA

Conditions Prolonged Anticoagulation; Venous Thromboembolic Disease; Autoimmune Hemolytic Anemia