rhTPO in Critical Patients With Thrombocytopenia

Phase 3UnknownNCT02094248

Jinling Hospital, China600 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

600

Conditions

Sepsis Thrombocytopenia

Interventions

TPODRUG

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

controlDRUG

Normal saline，1ml/day, s.c injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Nanjing Jinling Hospital

Nanjing, Jiangsu, China

RECRUITING

Outcomes

Primary Outcomes

Mortality

Time frame: 28-day after enrolled

Secondary Outcomes

Time to recover to a normal platelet level

Time frame: 10 days

Occurrence of bleeding event

Time frame: 10 days

7-day survival rate

Time frame: 7 days

Number of Participants who survived from thrombocytopenia

Time frame: 10 days

Occurrence of platelet transfusion

Time frame: 10 days

Total amount of platelet transfusion

Time frame: 10 days

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 frame: 10 days

Time to platelet response

Time frame: 10 days

Central Contacts

Qin Wu, MD

CONTACT

+86-15195916755 qinwu0221@gmail.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.