rhTPO in Critical Patients With Thrombocytopenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2016-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sepsis Thrombocytopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TPO

rhTPO（Recombinant Human Thrombopoietin，TPIAO®, Shenyang Sunshine Pharmaceutical Company Limited \[SUNSHINE\], Shenyang, China）， 15000U/ml, s.c injection

Group Type EXPERIMENTAL

TPO

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

control

Intervention Type DRUG

Normal saline，1ml/day, s.c injection

Interventions

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TPO

rhTPO（Recombinant Human Thrombopoietin，TPIAO®, Shenyang Sunshine Pharmaceutical Company Limited \[SUNSHINE\], Shenyang, China）， 15000U/ml, s.c injection

Intervention Type DRUG

control

Normal saline，1ml/day, s.c injection

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No