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

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DIJON · Oct 21, 2021

Keywords

ClinConnect Summary

This clinical trial is studying whether prolonged use of anticoagulation medication can help prevent blood clots in patients with autoimmune hemolytic anemia (AIHA). AIHA is a condition where the immune system mistakenly destroys red blood cells, leading to anemia and an increased risk of blood clots, especially during the first three months after diagnosis or relapse. The trial aims to find out if continuing anticoagulation treatment for 12 weeks after a diagnosis or flare-up of AIHA can reduce the occurrence of venous thromboembolism (VTE), which is a serious condition where blood clots form in veins.

To participate in the trial, individuals must be at least 18 years old and have a confirmed diagnosis of AIHA, showing specific blood test results. They should not have any immediate blood clotting issues or be currently on certain anticoagulation treatments. Participants will receive close monitoring and will be informed about the risks and benefits of the study. This research is important because it aims to provide clearer guidelines on how long to continue preventive treatment for VTE in patients with AIHA, potentially improving patient care and outcomes.

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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