The Alteration of Macrophage Function in the Spleen Tissues From Patients With Primary Immune Thrombocytopenia (ITP)
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ClinicalTrials.gov Identifier: NCT01869049
Recruitment Status :
(No eligible patient was enrolled.)
This project was undertaken by Qilu Hospital of Shandong University and other well-known hospitals in China. In order to report the alteration on the macrophage function in the spleen tissue of primary immune thrombocytopenia (ITP).
Evaluation of platelet response (Complete Response) [ Time Frame: The time frame is up to 3 months per subject ]
CR. A complete response (CR) was defined as a sustained (≥ 3 months) platelet count ≥ 100×10^9/L without recurrence of thrombocytopenia
Evaluation of platelet response (R) [ Time Frame: The time frame is up to 3 months per subject ]
R. A response (R) was defined as a sustained (≥ 3 months) platelet count ≥ 30×10^9/L without recurrence of thrombocytopenia
Evaluation of platelet response (No Response) [ Time Frame: The time frame is up to 3 months per subject ]
NR.No response (NR) was defined as platelet count < 30 × 10^9/L or a less than two fold increase in platelet count from baseline or the presence of bleeding. Platelet count must be measured on two occasions more than a day apart.
Secondary Outcome Measures :
Macrophage Function [ Time Frame: two weeks ]
Measure the platelet phagocytosis ability of macrophage in vitro
Biospecimen Retention: Samples With DNA
The biospecimens were retained for PCR, western blotting and FACS analysis.
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Ages Eligible for Study:
15 Years to 75 Years (Child, Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Chinese Adult with primary immune thrombocytopenia
adult ITP patients whose platelet counts remain less than 10 x 10^9/L
patients whose platelet counts remain less than 30 x 10^9/L and who continue to experience excessive bleeding after 4 to 6 weeks of appropriate medical treatment
patients who have experienced a transient response to primary treatment and have platelet counts less than 30 x 10^9/L after 3 months
require continuous glucocorticoid therapy to maintain safe platelet counts
Willing and able to sign written informed consent.
Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
Current HIV infection or hepatitis B virus or hepatitis C virus infections.
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 pregnant.
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.