Back to resultsrhTPO in Critical Patients With Thrombocytopenia
Primary Purpose
Sepsis, Thrombocytopenia
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
TPO
control
Sponsored by
About this trial
This is an interventional treatment trial for Sepsis
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
Sites / Locations
- Nanjing Jinling HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
TPO
control
Arm Description
rhTPO（Recombinant Human Thrombopoietin，TPIAO®, Shenyang Sunshine Pharmaceutical Company Limited [SUNSHINE], Shenyang, China）， 15000U/ml, s.c injection
Normal saline，1ml/day, s.c injection
Outcomes
Primary Outcome Measures
Mortality
Secondary Outcome Measures
Time to recover to a normal platelet level
Occurrence of bleeding event
7-day survival rate
Number of Participants who survived from thrombocytopenia
Occurrence of platelet transfusion
Total amount of platelet transfusion
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
Time to platelet response
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02094248
Brief Title
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
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
April 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jinling Hospital, China
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Thrombocytopenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TPO
Arm Type
Experimental
Arm Description
rhTPO（Recombinant Human Thrombopoietin，TPIAO®, Shenyang Sunshine Pharmaceutical Company Limited [SUNSHINE], Shenyang, China）， 15000U/ml, s.c injection
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
Normal saline，1ml/day, s.c injection
Intervention Type
Drug
Intervention Name(s)
TPO
Intervention Description
rhTPO（Recombinant Human Thrombopoietin，TPIAO®, Shenyang Sunshine Pharmaceutical Company Limited [SUNSHINE], Shenyang, China）， 15000U/ml, s.c injection
Intervention Type
Drug
Intervention Name(s)
control
Intervention Description
Normal saline，1ml/day, s.c injection
Primary Outcome Measure Information:
Title
Mortality
Time Frame
28-day after enrolled
Secondary Outcome Measure Information:
Title
Time to recover to a normal platelet level
Time Frame
10 days
Title
Occurrence of bleeding event
Time Frame
10 days
Title
7-day survival rate
Time Frame
7 days
Title
Number of Participants who survived from thrombocytopenia
Time Frame
10 days
Title
Occurrence of platelet transfusion
Time Frame
10 days
Title
Total amount of platelet transfusion
Time Frame
10 days
Title
Percentage of participants with platelet response
Description
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 Frame
10 days
Title
Time to platelet response
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qin Wu, MD
Phone
+86-15195916755
Email
qinwu0221@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianan Ren
Organizational Affiliation
Department of general surgery, Nanjing Jinling hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Nanjing Jinling Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gefei Wang, MD
Phone
+86-80860008
Email
wgfwang@gmail.com
First Name & Middle Initial & Last Name & Degree
Guosheng Gu, MD
Phone
+86-80860008
Email
guguoshengde@163.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
25986785
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.
Results Reference
derived
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rhTPO in Critical Patients With Thrombocytopenia
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