Sepsis, Thrombocytopenia
Conditions
Brief summary
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
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.
Interventions
DRUGTPO
rhTPO（Recombinant Human Thrombopoietin，TPIAO®, Shenyang Sunshine Pharmaceutical Company Limited \[SUNSHINE\], Shenyang, China）， 15000U/ml, s.c injection
DRUGcontrol
Normal saline，1ml/day, s.c injection
Sponsors
Jinling Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mortality | 28-day after enrolled |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of bleeding event | 10 days | — |
| 7-day survival rate | 7 days | — |
| Number of Participants who survived from thrombocytopenia | 10 days | — |
| Time to recover to a normal platelet level | 10 days | — |
| Total amount of platelet transfusion | 10 days | — |
| Percentage of participants with platelet response | 10 days | 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 |
| Time to platelet response | 10 days | — |
| Occurrence of platelet transfusion | 10 days | — |
Countries
China
Contacts
Primary ContactQin Wu, MD
Outcome results
None listed