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The primary objectives of this study are to assess the impact of rhTPO on mortality among severe sepsis patients with thrombocytopenia, as well as changes of platelet counts and platelet transfusion rates.
Thrombocytopenia is prevalent among critical patients who is admitted to intensive care unit. Researches have shown that thrombocytopenia is associated with mortality among those patients. Currently, no standard therapy exist for critical patients with Thrombocytopenia. In 2012 SSC guideline, platelet transfusion is induced for thrombocytopenia in critical patients for reducing the risk of bleeding. However, indication for platelet transfusion is relatively strict. No early intervention could be done according to this guideline. Previous studies have shown that recombinant human thrombopoietin can reduce severe sepsis with low platelet 28-day mortality in patients with hyperlipidemia, effectively improve peripheral platelet number, reducing the probability of platelet transfusion.The primary objectives of this study are to assess the impact of rhTPO on mortality among severe sepsis patients with thrombocytopenia, as well as changes of platelet counts and platelet transfusion rates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TPO | Experimental | rhTPOļ¼Recombinant Human Thrombopoietinļ¼TPIAOĀ®, Shenyang Sunshine Pharmaceutical Company Limited [SUNSHINE], Shenyang, Chinaļ¼ļ¼ 15000U/ml, s.c injection |
|
| control | Placebo Comparator | Normal salineļ¼1ml/day, s.c injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TPO | Drug | rhTPOļ¼Recombinant Human Thrombopoietinļ¼TPIAOĀ®, Shenyang Sunshine Pharmaceutical Company Limited [SUNSHINE], Shenyang, Chinaļ¼ļ¼ 15000U/ml, s.c injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | 28-day after enrolled |
| Measure | Description | Time Frame |
|---|---|---|
| Time to recover to a normal platelet level | 10 days | |
| Occurrence of bleeding event | 10 days | |
| 7-day survival rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qin Wu, MD | Contact | +86-15195916755 | qinwu0221@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianan Ren | Department of general surgery, Nanjing Jinling hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing Jinling Hospital | Recruiting | Nanjing | Jiangsu | 210000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25986785 | Derived | Wu Q, Ren J, Wang G, Gu G, Hu D, Liu S, Li G, Chen J, Li R, Hong Z, Ren H, Wu X, Li Y, Yao M, Zhao Y, Li J. Evaluating the safety and efficacy of recombinant human thrombopoietin among severe sepsis patients with thrombocytopenia: study protocol for a randomized controlled trial. Trials. 2015 May 19;16:220. doi: 10.1186/s13063-015-0746-6. |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D013921 | Thrombocytopenia |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| control | Drug | Normal salineļ¼1ml/day, s.c injection |
|
| 7 days |
| Number of Participants who survived from thrombocytopenia | 10 days |
| Occurrence of platelet transfusion | 10 days |
| Total amount of platelet transfusion | 10 days |
| Percentage of participants with platelet response | Platelet response was defined as platelet counts 50 x 10^9/L, measured at each study visit up to the end of the study period | 10 days |
| Time to platelet response | 10 days |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |