Immune Thrombocytopenia
Conditions
Keywords
Immune Thrombocytopenia, macrophage, spleen tissue
Brief summary
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).
Interventions
None listed
Sponsors
Shandong University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of platelet response (Complete Response) | 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) | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Macrophage Function | two weeks | Measure the platelet phagocytosis ability of macrophage in vitro |
Countries
China
Outcome results
None listed