Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05089227

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

338 weeks

Total Duration

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AI-Summary

What this Trial Is About

Autoimmune hemolytic anemia (AIHA) is a rare autoimmune disease (incidence \<1/100,000 population) responsible for the destruction of red blood cells by the host immune system, notably through the action of autoantibodies. Apart from complications related to anemia, the occurrence of venous thromboembolism (VTE) in this population is frequent, estimated at 20-27%. The risk of VTE is highest during the period of hemolysis, especially during the first 3 months after the diagnosis of AIHA. This risk is 7.5 \[4.7; 12.0\] times greater than in the general population. No clinical predictive factor for VTE was identified and the usual factors (cancer, previous VTE, bed rest \>3 days, surgery, age \>70 years, heart or respiratory failure, myocardial infarction, stroke, obesity, hormone replacement therapy) were not considered. Several biological risk factors have been suggested (depth of anemia, bilirubin level, leukocyte count, antiphospholipid antibodies) but have not been confirmed in other studies. AIHA is therefore a risk factor for VTE in its own right, and the National Diagnostic and Care Protocol (NDCP) recommends the implementation of VTE prevention during acute hemolysis (Grade C). However, the value of this prophylaxis has never been prospectively evaluated and its duration is empirical. In practice, low-molecular-weight heparin (LMWH) is generally used during "flare-ups" of AIHA (diagnosis and relapse) in hospitalized patients, but is rarely continued beyond the hospital phase when VTE also occurs in ambulatory patients. Thus, we hypothesize that prolonged preventive anticoagulation during the 12-week risk period following diagnosis or relapse of AIHA could decrease the incidence of VTE. In orthopedic surgery, this strategy has been proven to decrease VTE from 50% to 10-15%. In certain high-risk medical situations, prolonged prophylaxis with apixaban has been shown to decrease the occurrence of VTE from 10.2% to 4.2% in solid cancers4 and from 4-11% to 2% in myeloma.

CONDITIONS

Official 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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient aged  18 years
  • Diagnosis of primary or secondary autoimmune hemolytic anemia (AIHA) with hemoglobin <12 g/dL, decreased haptoglobin (<0.4 g/L), and positive direct antiglobulin test (IgG +/- C3d)
  • Newly diagnosed or experiencing a relapse of AIHA
  • Estimated life expectancy greater than 6 months
  • Provided free, written, and informed consent
Not Eligible

You will not qualify if you...

  • Immediate symptomatic venous thromboembolism confirmed by imaging
  • Currently on curative anticoagulation therapy for venous thromboembolic disease or atrial fibrillation
  • Receiving dual antiaggregation treatment
  • Active bleeding or known bleeding risk condition
  • Ischemic stroke with hemorrhagic transformation within 6 months prior to inclusion
  • On preventive anticoagulation for 14 days or more
  • Contraindication to apixaban including hypersensitivity, thrombocytopenia <100 G/L, kidney failure (glomerular filtration rate <30 ml/min/1.73m8), or active liver disease
  • Taking certain CYP3A4 inducers or inhibitors that cannot be stopped
  • Contraindication to enoxaparin such as allergy or history of heparin-induced thrombocytopenia
  • Cold agglutinin-related autoimmune hemolytic anemia
  • Severe bleeding disorders like hypofibrinogenemia, disseminated intravascular coagulation, or hemophilia
  • Requires intensive care unit hospitalization
  • Previous participation in this study
  • Not affiliated with national health insurance
  • Under legal protection or guardianship
  • Pregnant, breastfeeding, or unable to use effective contraception if physiologically capable of procreating
  • Unable to provide informed consent

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Chu Dijon Bourgogne

Dijon, France, 21000

Actively Recruiting

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Research Team

S

Sylvain AUDIA

CONTACT

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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