With the mission of establishing venous thrombosis records in Brazil, the Thromboembolic Diseases Center (CDT) of the Unicamp Blood Center was opened in Campinas. The initiative is in partnership with the Brazilian Society of Thrombosis and Hemostasis (SBTH) and was approved by the Development Centers Program of the São Paulo State Research Support Foundation (Fapesp), which, together with the Dean of Research of the Unicamp provided a contribution of R$4 million to complete the project.
Venous thrombosis is a disease characterized by the formation of thrombi (clots) in the veins of any part of the body, but mainly in the veins of the legs, and which can evolve into a pulmonary embolism if the thrombus moves through the bloodstream. Although it is the third leading cause of death among cardiovascular diseases, it can be avoided in the vast majority of cases. In Brazil, there is still no robust data on its occurrence in the population. As a consequence, public strategies to mitigate the disease are based on studies published by other countries – which have different ethnic and socioeconomic profiles than Brazil.
The inauguration of the CDT will impact this situation by establishing three large registries focused on thrombosis: the first in adults with an acute illness, the second in hospitalized children and the third in patients with cancer – a risk factor for the occurrence of thromboembolic events. To this end, a network was created made up of hospital centers located in six municipalities in the State of São Paulo (Campinas, Botucatu, São José do Rio Preto, São Paulo, Barretos and Ribeirão Preto), which will include more than 10 thousand patients in the program, invited in person on their first visit to a hospital and then monitored throughout the study via WhatsApp or telephone.
“We would like to be able to start with several centers in Brazil, but, due to the size of our country and to be able to have more experience in developing this type of project, it is important to start with our state”, explains hematologist Joyce Annichino, who is professor, coordinator of the clinical and laboratory area of Thromboembolic Diseases at the Unicamp Blood Center and vice-president of SBTH.
According to the professor, a pilot study on thrombosis with this same model was carried out in Campinas at the Hospital de Clínicas, at the Hospital da Mulher José Aristodemo Pinotti - Caism Unicamp, at the Hemocentro da Unicamp, at the Hospital Celso Pierro of the Pontifical Catholic University (PUC ) and at the Dr. Domingos Boldrini Hospital. At the time, 800 cancer patients and around 6 hospitalized children were evaluated, but in the case of people with acute thrombosis, it was not possible to continue the study due to the Covid-19 pandemic. “Very interesting data were generated, because we didn't have anything like that in Brazil, but, with the CDT, we will evaluate a much larger number of patients in a multicenter project, with the capital and several important cities in the interior of São Paulo, which is much more relevant”, explains Joyce.
In total, 14 hospital centers make up the CDT network: the Hospital de Clínicas, the Hemocentro and the CAISM – all from Unicamp; the PUC Hospital and the Dr. Domingos Boldrini Hospital in Campinas; the Hospital das Clínicas of the Faculty of Medicine of the Universidade Estadual Paulista (Unesp) in Botucatu; the Base Hospital of the Foundation of the Faculty of Medicine of São José do Rio Preto; the Hospital do Amor de Barretos; the Hospital das Clínicas of the Faculty of Medicine of the University of São Paulo (USP) in Ribeirão Preto; and, in the capital of São Paulo, the Hospital Municipal Dr. Moysés Deutsch-M'Boi Mirim, the Hospital Municipal Vila Santa Catarina, the Hospital Santa Marcelina de Itaquera, the Hospital das Clínicas da USP and the Hospital Universitário da Universidade Federal de São Paulo ( Unifesp).
The study, which will last five years, will collect prospective data from patients for a period of up to 24 months and will have the support of the companies Stago, Daiichi Sankyo, Sanofi, Pfizer, Siemmens, Werfen and Sigvaris. In addition, blood will be collected from patients included in the program, which will be stored in a biobank at the Unicamp Blood Center. “The information collected will be inserted into a REDCap platform, allowing the formation of a big data which, following all ethical standards, can generate valuable information, contributing to the improvement and dissemination of measures in clinical practice”, reports the professor.
Application of results
To understand how thrombosis occurs in Brazil, the CDT will collect a wide range of information about the patient, such as age, sex, profession, place of birth, weight and height, as well as data on the use of medications, hereditary and acquired risk factors that contributed to thrombosis, the occurrence of complications and the need for new hospitalizations during the evaluation period. From this data, it will be possible to have a view of how patients are being treated, whether they have more complications than populations in other countries and the costs of therapy for the Unified Health System (SUS).
According to Annichino, so-called micro-costing studies are important because they estimate the real costs of long-term treatment. An example is post-thrombotic syndrome, a very common complication when a person has thrombosis in the lower limbs and which is usually relegated to a secondary level because the risk of death is almost non-existent, but it is an occurrence that can greatly affect the quality of life of the patient and has an impact on treatment costs. “Sometimes you have a cheaper medicine available, but that doesn’t mean the cost is lower because there are complications that will require hospitalization or even cause death. In this way, micro-costing studies can help with strategies for releasing new medicines or even for prevention”, she explains.
Identification of biomarkers
The CDT also established a partnership with Professor Ljubica Tasic, from the Unicamp Chemistry Institute, for metabolomic analyzes of patients' blood samples, in an attempt to identify biomarkers related to the risk of thrombosis. Furthermore, with the collaboration of professors Rubens Maciel, from the Faculty of Engineering at Unicamp (FEQ), and Thiago Martins, from the Escola Paulista de Medicina da Unifesp, the center intends to evaluate clinical and laboratory data from the records with the use of Artificial Intelligence . The purpose, therefore, is to generate scores to predict the risk of thrombosis occurring in situations such as cancer, child hospitalization, post-thrombotic syndrome and recurrence in patients with venous thrombosis.
The data obtained should assist in the development of public and educational strategies for professionals, patients and the general population. Some of the planned initiatives include applications for medical use, training for laboratory personnel, webinars to discuss thrombosis cases and specific courses on chronic venous insufficiency. “In the future, we are thinking about forming partnerships with airlines, because one of the risk factors for thrombosis is long plane trips. Educate passengers to drink plenty of fluids, move around and, especially in the case of elderly people or people with comorbidities, check the need to use elastic stockings or an anticoagulant as prevention”, explains the teacher. October 13th is considered International Venous Thrombosis Day and the CDT intends to carry out a broad campaign to provide information about the disease.
See images of the location where the Center for Thromboembolic Diseases (CDT) will operate: