Sepsis | rhTPO in Critical Patients With Thrombocytopenia
Sepsis research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:TPOrhTPO（Recombinant Human Thrombopoietin，TPIAO®, Shenyang Sunshine Pharmaceutical Company Limited [SUNSHINE], Shenyang, China）， 15000U/ml, s.c injection
Drug:controlNormal saline，1ml/day, s.c injection
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
TPOrhTPO（Recombinant Human Thrombopoietin，TPIAO®, Shenyang Sunshine Pharmaceutical Company Limited [SUNSHINE], Shenyang, China）， 15000U/ml, s.c injection
controlNormal saline，1ml/day, s.c injection
Start Date: March 2014
Completed Date: April 2016
Phase: Phase 2/Phase 3
Primary Outcome: Mortality
Secondary Outcome: Time to recover to a normal platelet level
Study sponsors, principal investigator, and references
Principal Investigator: Jianan Ren
Lead Sponsor: Jinling Hospital, China