rhTPO in Critical Patients With Thrombocytopenia

Phase 2

• Conditions: Sepsis; Thrombocytopenia
• Interventions: Drug: control; Drug: TPO

• Registration Number: NCT02094248
• Lead Sponsor: Jinling Hospital, China

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.

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-17
• Study First Submitted QC: 2014-03-19
• Study First Posted: 2014-03-21
• Status Verified: 2014-06
• Last Update Submitted: 2015-05-19
• Last Update Posted: 2015-05-21
• Primary Completion: 2016-03
• Study Completion: 2016-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Mortality	28-day after enrolled

Secondary Outcome Measures

Name	Time	Method
Number of Participants who survived from thrombocytopenia	10 days
Occurrence of platelet transfusion	10 days
Total amount of platelet transfusion	10 days
Percentage of participants with platelet response	10 days	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	10 days
Time to recover to a normal platelet level	10 days
Occurrence of bleeding event	10 days
7-day survival rate	7 days

Trial Locations

Locations (1)

Nanjing Jinling Hospital; 🇨🇳 Nanjing, Jiangsu, China