rhTPO in Critical Patients With Thrombocytopenia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized, Open-label, Placebo-controlled, Multi-center Study to Evaluate Safety and Efficacy of Recombinant Human Thrombopoietin Among Severe Sepsis Patients With Thrombocytopenia

Conditions
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Sepsis, Thrombocytopenia

Intervention / Treatment
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* Drug: TPO
* Drug: control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients would be include if Diagnosed as sepsis according to ACCP/CCM criteria Platelet counts is less than 50×109/L for 2 continues days Patient or legally authorized representative able to provide informed consent Exclusion Criteria: Subject has had a splenectomy for any reason Subject has an active malignancy who is now under chemotherapy Subject has a known history of bone marrow stem cell disorder Subject is receiving other investigational agents or procedures Subject is currently enrolled in, or has completed within the last 30 days, another investigational device or drug study Subject is pregnant or breast feeding Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and does not have a legally acceptable representative Subject has any kind of disorder that compromises the ability of the subject to comply with study procedures Subject is less than 18 years or more than 85 years of age History of bone marrow, lung, liver, pancreas, or small-bowel transplantation Acute pancreatitis with no established source of infection

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TPO<br>rhTPO（Recombinant Human Thrombopoietin，TPIAO®, Shenyang Sunshine Pharmaceutical Company Limited [SUNSHINE], Shenyang, China）， 15000U/ml, s.c injection | Drug: TPO<br>* rhTPO（Recombinant Human Thrombopoietin，TPIAO®, Shenyang Sunshine Pharmaceutical Company Limited [SUNSHINE], Shenyang, China）， 15000U/ml, s.c injection<br>|
| Placebo Comparator: control<br>Normal saline，1ml/day, s.c injection | Drug: control<br>* Normal saline，1ml/day, s.c injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 28-day after enrolled | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to recover to a normal platelet level |  | 10 days | 
| Occurrence of bleeding event |  | 10 days | 
| 7-day survival rate |  | 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 |