rhTPO in Critical Patients With Thrombocytopenia
A Randomized, Open-label, Placebo-controlled, Multi-center Study to Evaluate Safety and Efficacy of Recombinant Human Thrombopoietin Among Severe Sepsis Patients With Thrombocytopenia
1 other identifier
interventional
600
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 sepsis
Started Mar 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 17, 2014
CompletedFirst Posted
Study publicly available on registry
March 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedMay 21, 2015
June 1, 2014
2 years
March 17, 2014
May 19, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Mortality
28-day after enrolled
Secondary Outcomes (8)
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
- +3 more secondary outcomes
Study Arms (2)
TPO
EXPERIMENTALrhTPO（Recombinant Human Thrombopoietin，TPIAO®, Shenyang Sunshine Pharmaceutical Company Limited \[SUNSHINE\], Shenyang, China）， 15000U/ml, s.c injection
control
PLACEBO COMPARATORNormal saline，1ml/day, s.c injection
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nanjing Jinling Hospital
Nanjing, Jiangsu, 210000, China
Related Publications (1)
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.
PMID: 25986785DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jianan Ren
Department of general surgery, Nanjing Jinling hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice president of General Surgery Department
Study Record Dates
First Submitted
March 17, 2014
First Posted
March 21, 2014
Study Start
March 1, 2014
Primary Completion
March 1, 2016
Study Completion
April 1, 2016
Last Updated
May 21, 2015
Record last verified: 2014-06