rhTPO in Critical Patients With Thrombocytopenia

Sepsis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02094248
• Other study ID #: TPO Study
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: March 17, 2014
• Last updated: May 19, 2015
• Start date: March 2014
• Est. completion date: April 2016

Study information

• Verified date: June 2014
• Source: Jinling Hospital, China
• Contact: Qin Wu, MD
• Phone: +86-15195916755
• Email: qinwu0221[@]gmail.com
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: April 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sepsis
• Thrombocytopenia
• Thrombocytosis

Intervention

Drug:
• TPO
rhTPO(Recombinant Human Thrombopoietin,TPIAO®, Shenyang Sunshine Pharmaceutical Company Limited [SUNSHINE], Shenyang, China), 15000U/ml, s.c injection
• control
Normal saline,1ml/day, s.c injection

Locations

Country	Name	City	State
China	Nanjing Jinling Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jinling Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		28-day after enrolled	No
Secondary	Time to recover to a normal platelet level		10 days	No
Secondary	Occurrence of bleeding event		10 days	Yes
Secondary	7-day survival rate		7 days	No
Secondary	Number of Participants who survived from thrombocytopenia		10 days	No
Secondary	Occurrence of platelet transfusion		10 days	No
Secondary	Total amount of platelet transfusion		10 days	No
Secondary	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	10 days	No
Secondary	Time to platelet response		10 days	No