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

Who is this study for? Patients with Venous Thromboembolic Disease
Status: Recruiting
Location: See location...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Chu Dijon Bourgogne
RECRUITING
Dijon
Contact Information
Primary
Sylvain AUDIA
sylvain.audia@chu-dijon.fr
03.80.29.34.32
Time Frame
Start Date: 2022-02-03
Estimated Completion Date: 2028-08
Participants
Target number of participants: 72
Treatments
Experimental: intervention group
Active_comparator: standard group
Sponsors
Leads: Centre Hospitalier Universitaire Dijon

This content was sourced from clinicaltrials.gov