Ignite Creation Date:
2024-05-06 @ 2:39 AM
Last Modification Date:
2024-10-26 @ 11:21 AM
Study NCT ID:
NCT02094248
Status:
UNKNOWN
Last Update Posted:
2015-05-21
First Post:
2014-03-17
Brief Title:
rhTPO in Critical Patients With Thrombocytopenia
Sponsor:
Jinling Hospital China
Organization:
Jinling Hospital China
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2014-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 transfusionThe 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None