An observational study in Immune Thrombocytopenia, sponsored by Shandong University. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-09-09.
Sponsored by Shandong University · Observational
The project was undertaking by Qilu Hospital of Shandong University in China. The objective is to find out if there is a connection between vitamin D level and the efficacy of dexamethasone for the treatment of adults with newly-diagnosed primary immune thrombocytopenia (ITP).
The investigators anticipate to undertaking a prospective, observational，non-randomized control trial of 60 ITP adult patients. Dexamethasone (given orally at a dose of 40 mg per day for 4 days, two-cycles with an interval of 10 days) will be used in the target patients. Vitamin D level will be detected before the utilization of treatment measures. Depend on the vitamin D level, the patients will be divided into 2 groups(higher vitamin D level group and lower vitamin D level group).Platelet count, bleeding and other symptoms were evaluated before and after treatment.
697 studies on the registry are indexed under Thrombocytopenia; 153 are open to participants now.
This study's planned enrollment of 60 is below the median of 120 across 183 observational studies indexed under Thrombocytopenia.
Browse Thrombocytopenia studies →Shandong University is the lead sponsor of 284 studies on the registry; 59 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Newly diagnosed ITP patients
Corresponding to the diagnostic criteria for immune thrombocytopenia Newly diagnosed ITP patients To show a platelet count \<30 * 10\^9/L, and with bleeding manifestations Willing and able to sign written informed consent
Exclusion Criteria:
Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit; Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit; Received high-dose steroids or IVIG in the 3 weeks prior to the start of the study; Current HIV infection; Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia) Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period; Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test; Patients who are deemed unsuitable for the study by the investigator.
The vitamin D level is lower than 20 nmol/L.
Drug: Dexamethasone
The vitamin D level is higher than 20 nmol/L.
Drug: Dexamethasone
HD-DXM (orally at 40 mg daily for 4d )
Sustained response to ITP treatments
Percentage of patients maintaining PLT count over 30\*10\^9/L without bleeding
Time frame: 3 months after treatment started
No study locations are listed for this record.
This study is status unknown, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Shandong University