Clinical trial NCT02094248: rhTPO in Critical Patients With Thrombocytopenia
Official title: A Randomized, Open-label, Placebo-controlled, Multi-center Study to Evaluate Safety and Efficacy of Recombinant Human Thrombopoietin Among Severe Sepsis Patients With Thrombocytopenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Sepsis
Thrombocytopenia
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2014-03-21
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mortality
timeFrame: 28-day after enrolled
Secondary outcomes:
measure: Time to recover to a normal platelet level
timeFrame: 10 days
measure: Occurrence of bleeding event
timeFrame: 10 days
measure: 7-day survival rate
timeFrame: 7 days
measure: Number of Participants who survived from thrombocytopenia
timeFrame: 10 days
measure: Occurrence of platelet transfusion
timeFrame: 10 days
measure: Total amount of platelet transfusion
timeFrame: 10 days
measure: Percentage of participants with platelet response
timeFrame: 10 days
measure: Time to platelet response
timeFrame: 10 days
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Jinling Hospital
state: Jiangsu
Study officials:
affiliation: Department of general surgery, Nanjing Jinling hospital
name: Jianan Ren
role: STUDY_CHAIR
References:
citation: 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.