View clinical trials related to Thrombocytopenia.
Filter by:This project was undertaken to evaluate the efficacy and safety of BTK inhibitor Zanubrutinib for the secondary treatment of adults with primary immune thrombocytopenia (ITP).
Background/Rationale: A very rare syndrome of thrombosis associated with low platelets has been reported in a few cases of recent exposure to COVID-19 vaccine. This thrombotic thrombocytopenia syndrome seems to be affecting patients of all ages and both genders; at present there is no clear signal of risk factors. Objectives: To evaluate an association between COVID-19 vaccine exposure and thromboembolic events occurring with thrombocytopenia (thrombotic thrombocytopenia syndrome; TTS). Study design: Two primary study designs will be considered, a case control study and a self-controlled case series (SCCS). A cohort analysis will be considered, in addition or as an alternative to either of the primary study designs, pending feasibility assessment of the follow-up time. Data Source(s): Data for the study will be accessed through the NHS Digital Trusted Research Environment (TRE), providing national data coverage. Primary care data will be linked with vaccination, hospitalization, COVID-19 test results, mortality data. Initial exploratory analyses will be conducted using the Oxford-Royal College of General Practitioners sentinel network; ORCHID network database (N>15million). Subjects of interest are patients who have received a COVID-19 vaccine. However, investigators will require access to data from all subjects in the databases. Statistical Analysis: The study period will start on December 02, 2020, when the COVID-19 vaccine was first approved in the UK and will end at the end of data availability. For the case-control design, all cases of TTS will be matched with control using risk-set matching. A case or matched control will be considered exposed if a COVID-19 vaccination will be within risk interval prior to the diagnosis date of the matched case. For the SCCS, estimates of relative incidence (RI), in all risk intervals will be reported. For the retrospective cohort design, the incidence of TTS after receiving COVID-19 vaccine will be estimated and investigators will compare this incidence with that occurring in an unvaccinated comparator group about levels of infection across the whole population. Variables: Demographic, socioeconomic descriptors, clinical diagnosis, vaccines, potential confounders, thrombotic phenomena, COVID-19 infection, and other characteristics as applicable.
Background/Rationale: A rare syndrome of thrombosis associated with low platelets has been reported in a few cases of recent exposure to COVID-19 vaccine. Medicines & Healthcare products Regulatory Agency (MHRA) had requested for all cases of thrombosis or thrombocytopenia occurring within 28 days of coronavirus vaccine to be reported via the online yellow card system. This syndrome seems to be affecting patients of all ages and both genders; at present there is no clear signal of risk factors. Up to and including 14 April 2021, the MHRA had received 168 United Kingdom (UK) reports of thrombo-embolic events with concurrent low levels of platelets following the use of the COVID-19 Vaccine AstraZeneca. The United Kingdom (UK) is uniquely placed to study this area because of its registration-based primary care system, and a unique identifier number links primary care to secondary care data. Additionally, vaccination is well advanced, maximising population wide vaccine exposure. Objectives and Hypotheses: Estimate event rates and describe characteristics of patients with a record for thrombotic thrombocytopenia syndrome, thromboembolism or thrombocytopenia, in the general population of England. Methods: Study design: Secondary data analysis using a cohort design. Data Source(s): This is a retrospective cohort study using linked secondary databases in England accessed through the NHS Digital Trusted Research Environment (TRE). The primary care data will be linked with vaccination, primary care data, hospitalization, COVID-19 test results, mortality data at the national level for capture of key study variables. This integrated digital health system will also include other linkages such as the Oxford-Royal College of General Practitioners sentinel network; ORCHID. Study Population: All patients, with our population of interest in England who are present in the integrated health records of NHS Digital TRE and/or the Oxford Royal College of General Practitioners Clinical Informatics Digital Hub (ORCHID) database at the start of each study period. Variables: Demographic, socioeconomic, clinical descriptors and risk factors for thrombosis and/or thrombocytopenia; COVID-19 vaccines. Statistical Analysis: The event rates with 95% CIs will be calculated by dividing the number of events with person-time at risk per 100,000 person-years. Further, event count and event rates will be evaluated in a relationship with COVID-19 vaccination date.
The project was retrospectively undertaking by Qilu Hospital of Shandong University in China. In order to investigate the correlations between platelet indices, serum lipids and bleeding symptoms in ITP.
The purpose of this study is to study the safety and efficacy of pooled buffy-coat derived platelets which had been frozen with dimethyl sulphoxide (DMSO), in the prevention of bleeding for patients with hypoproliferaitve thrombocytopenia. These platelets are hereafter referred to as cryopreserved platelets. Patients who have severely low platelet count due to impaired bone marrow function from chemotherapy or certain haematological conditions may need platelet transfusion to prevent spontaneous bleeding. Currently, platelets are stored in liquid form, and must be used within five to seven days of collection. In this study, DMSO is used to preserve platelets during freezing so that they can be stored for longer than five to seven days. Investigators hope to learn if thawed cryopreserved platelets are functional and safe for transfusion in humans.
Primary immune thrombocytopenia (ITP) is an autoimmune bleeding disorder with low platelet count. As the first choice of the second-line treatment of ITP, thrombopoietin receptor agonist (TPO-RA) enable long-term remission in 50% to 60% of cases. However, about half of patients have no response or loss of response to eltrombopag due to unknown reasons, which can't be effectively improved by increasing the drug dose. Diacerein is an anthraquinone derivative used to treat joint diseases such as osteoarthritis. We speculate that the addition of diacerein to eltrombopag may offer sensitizer effect and maximize efficacy, which warrants further prospective studies to evaluate the efficacy and safety of the combination therapy as salvage strategy in ameliorating immune thrombocytopenia.
This is a phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group trial to evaluate the efficacy, safety, and effect on QoL/PRO of efgartigimod PH20 SC treatment in adult patients with primary ITP.
Primary Objective: - To evaluate the effect of BIVV020 on the durability of platelet response in participants with persistent/chronic immune thrombocytopenia (ITP) Secondary Objectives: - To assess the safety and tolerability of BIVV020 - To assess the pharmacokinetics of BIVV020 - To assess the response rate of treatment with BIVV020 - To assess the time to response - To assess the effect of treatment with BIVV020 on the requirement for rescue ITP therapy - To assess the immunogenicity of BIVV020
Evaluate the safety and tolerability of avatrombopag given for 90 days after stopping treatment with eltrombopag or romiplostim.
To observe the clinical efficacy and safety of avatrombopag for chemotherapy-induced thrombocytopenia in patients with malignant tumors.