Actively Recruiting
Efficacy of Prolonged Anticoagulation for Primary Prevention of Venous Thromboembolic Disease in Autoimmune Hemolytic Anemia: a Prospective, Phase II, Randomized, Multicenter Study
Led by Centre Hospitalier Universitaire Dijon · Updated on 2025-12-22
72
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Autoimmune hemolytic anemia (AIHA) is a rare autoimmune disease where the body's immune system destroys red blood cells, leading to anemia and a high risk of venous thromboembolism (VTE), especially within the first three months after diagnosis or relapse. The risk of VTE in AIHA patients is significantly higher than in the general population, but no clear clinical predictors have been identified. This study is a prospective, phase II, randomized, multicenter trial aiming to evaluate whether prolonged anticoagulation can reduce VTE occurrence in AIHA patients during this high-risk period. Participants will be randomly assigned to one of two groups. The intervention group will receive prophylactic heparin therapy during hospitalization followed by 12 weeks of oral anticoagulation with apixaban. The standard group will receive prophylactic heparin only during hospitalization, with no further preventive anticoagulation after discharge. Biological assessments including blood counts and markers related to hemolysis will be conducted. During the study, participants will be monitored for clinical venous thromboembolic events such as deep vein thrombosis and pulmonary embolism up to 24 weeks after randomization. Blood tests including complete blood count, reticulocytes, haptoglobin, LDH, and bilirubin will be collected. The trial involves follow-up visits to evaluate outcomes and ensure participant safety, with total involvement lasting several months to assess the effectiveness of prolonged anticoagulation in preventing VTE.
CONDITIONS
Brief Title
Efficacy of Prolonged Anticoagulation for Primary Prevention of Venous Thromboembolic Disease in Autoimmune Hemolytic Anemia: a Prospective, Phase II, Randomized, Multicenter Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient aged 69 18 years
- Diagnosis of primary or secondary autoimmune hemolytic anemia (AIHA) confirmed by hemoglobin <12 g/dL, decreased haptoglobin <0.4 g/L, and positive direct antiglobulin test (Coombs test) (IgG +/- C3d)
- Newly diagnosed or relapse of AIHA
- Estimated life expectancy greater than 6 months
- Provided free, written, and informed consent
You will not qualify if you...
- Immediate symptomatic venous thromboembolism confirmed by appropriate tests
- Current curative anticoagulation treatment for blood clots or atrial fibrillation
- On dual antiplatelet therapy
- Active bleeding or known condition/lesion increasing bleeding risk
- Ischemic stroke with hemorrhagic transformation within 6 months prior to inclusion
- Preventive anticoagulation for 14 days or more before inclusion
- Contraindication to apixaban, including hypersensitivity, thrombocytopenia <100 G/L, kidney failure (GFR <30 ml/min/1.73m²), or active liver disease
- Use of certain CYP3A4 inducers or inhibitors that cannot be stopped or changed
- Contraindication to enoxaparin such as allergy or history of heparin-induced thrombocytopenia
- Cold agglutinin-related AIHA
- Severe hemostasis disorders (hypofibrinogenemia <2 g/L, disseminated intravascular coagulation, hemophilia)
- Clinical condition requiring intensive care unit hospitalization
- Previous participation in this study
- Not affiliated with national health insurance
- Under legal protection (curatorship, guardianship) or subject to legal protection measures
- Pregnant, breastfeeding, or unable to use effective contraception if of childbearing potential
- Unable to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 weeks
Participants receive prophylactic heparin therapy during hospitalization followed by either prophylactic oral anticoagulation with apixaban or management without prophylactic anticoagulation for a total of 12 weeks.
Trial Site Locations
Total: 1 location
1
Chu Dijon Bourgogne
Dijon, France, 21000
Actively Recruiting
Research Team
S
Sylvain AUDIA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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