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Evaluation of safety and efficacy of radiosynovectomy with 153-samarium-hydroxyapatite in patients with hemophilia

Grant number: 13/05255-7
Support type:Regular Research Grants
Duration: June 01, 2013 - May 31, 2015
Field of knowledge:Health Sciences - Medicine - Medical Radiology
Principal Investigator:Allan de Oliveira Santos
Grantee:Allan de Oliveira Santos
Home Institution: Faculdade de Ciências Médicas (FCM). Universidade Estadual de Campinas (UNICAMP). Campinas , SP, Brazil
Assoc. researchers:Celso Darío Ramos ; Margareth Castro Ozelo

Abstract

Hemophilia is a hereditary hemorraghic disorder caused by the deficiency of coagulative activity of factor VIII (hemophilia A) or factor IX (hemophilia b). Clinical presentation is similar in hemophilia A or B and is characterized by intra-articular bleeding (hemarthrosis), muscular and other organ and cavities hemorrhages. Intra-articular bleeding is the most common and painful musculoskeletal manifestation and has economical, physical and psychological impact that causes the disabling effects of hemophilia. Multiple hemarthrosis result in a proliferative and inflamatory disease known as chronic hemophilic synovitis. Although the sequence of clinical events: hemarthrosis - chronic synovitis - hemarthrosis is already well documented, the blood components and the molecular changes responsible for the synovitis are not completely studied. In the evolution, progressive and disabling consequences occur due to the progression of articular damage (chronic hemophilic arthopathy).Clinical experience with hemarthrosis treatment with factor concentrate reposition shows a reduction in the prevalence of the chronic arthropathy. However, this is not enough to prevent completely chronic synovitis. Synoviorthesis is a treatment option that delays the development of hemophilic arthopathy. This study intends to evaluate propesctively the viability, efficacy and safety of radiosynovectomy with hydroxyapatite labeled with samarium-153 (153Sm) in the treatment and control of recurrent hemarthrosis in patients with hemophlia and severe von Willebrand disease with chronic synovitis followed by Hemophilia Treatment Unit of Hematology and Hemotherapy Center of Campinas University (UNICAMP). There are 231 patients with hemophilia A and 65 patients with hemophilia B registered at this unit. One-hundred fifty five of them are classified as severe cases, 71 as moderates and 70 mild. Due to the lack of local programs of primary prophylaxia, the frequency of chronic synovitis is high among those patients. Hemophilic patients older than 6 years of age and a target joint (3 or more hemarthrosis in the same joint during a 3-month period) will be included. Twenty knees and 20 ankles/elbows will be treated. Effective doses in the knees of the patients will be estimated and compared with the effective obtained in treatments with yttrium-90. Post-treatment images will be obtained to evaluate eventual extra-articular leakage and peripheral blood samples will be collected to search for chromosomal aberrations. The occurrence of side-effects, the frequency of hemarthrosis and the amount of coagulation factor used for hemarthosis control and the articular score evaluated 6 months after treatment will be compared to the same parameters observed 12 months prior to treatment . (AU)