The Alteration of Macrophage Function in the Spleen Tissues From Patients With Primary Immune Thrombocytopenia (ITP)
Verified April 2013 by Shandong University
Information provided by (Responsible Party):
Ming Hou, Shandong University
First received: April 3, 2013
Last updated: May 30, 2013
Last verified: April 2013
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).
||Observational Model: Cohort
Time Perspective: Prospective
||A Study on the Alteration of Macrophage Function in the Spleen Tissue From Patients With Primary Immune Thrombocytopenia (ITP): a Multicenter, Perspective, Clinical Trial
Primary Outcome Measures:
- Evaluation of platelet response (Complete Response) [ Time Frame: The time frame is up to 3 months per subject ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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.
Biospecimen Retention: Samples With DNA
Secondary Outcome Measures:
The biospecimens were retained for PCR, western blotting and FACS analysis.
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||September 2013 (Final data collection date for primary outcome measure)
ITP patients accepted splenectomy
Trauma with spleen rupture underwent splenectomy
|Ages Eligible for Study:
||15 Years to 75 Years
|Genders 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01869049
|Qilu Hospital, Shandong University
|Jinan, Shandong, China, 250012 |
|Contact: Jun Peng, dr. +8613553157577 firstname.lastname@example.org |
|Principal Investigator: Jun Peng, dr. |
||Jun Peng, dr.
||Qilu Hospital, Shandong University
No publications provided
||Ming Hou, professor, Shandong University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 3, 2013
||May 30, 2013
||China: Ministry of Health
Keywords provided by Shandong University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on February 25, 2015
Blood Platelet Disorders