The Effect of Recombinant Human Thrombopoietin(rhTPO) on Sepsis Patients With Acute Severe Thrombocytopenia：a Prospective, Multi-center, Open-label, ,Randomized, Controlled Trial
Who is this study for? Adult patients with sepsis and thrombocytopenia
What treatments are being studied? rhTPO
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
The purpose of this study is to determine whether recombinant human thrombopoietin(rhTPO) can rapidly increase the platelets counts, shorten the time of the platelet returned to normal, reduce platelet transfusion and bleeding events, prompt recovery of organ function, decrease the length of ICU stay, and eventually reduce the 28-day mortality in sepsis patients with severe thrombocytopenia.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:
• Confirmed or clinical diagnosed infection
• The change of Sequential Organ Failure Assessment(ΔSOFA) score ≥ 2
• PLT\< 50×10\^9/L
• Informed consent
Locations
Other Locations
China
Shanghai General Hospital, Shanghai Jiaotong University
RECRUITING
Shanghai
Contact Information
Primary
Ruilan Wang, MD,PhD
wangyusun@hotmail.com
+86-13917138008
Time Frame
Start Date: 2019-04-01
Estimated Completion Date: 2024-09-30
Participants
Target number of participants: 200
Treatments
Experimental: rhTPO
Recombinant Human Thrombopoietin，TPIAO®, Shenyang Sunshine Pharmaceutical Company Limited \[SUNSHINE\], Shenyang, China）， 15000u/d, qd, subcutaneous injection, daily for no more than 7 consecutive days
Placebo_comparator: placebo
The control group will not use any platelet-increased drugs.
Authors
Ruilan Wang
Related Therapeutic Areas
Sponsors
Leads: Ruilan Wang
Collaborators: Shanghai University of Traditional Chinese Medicine, Huadong Hospital, Shanghai Jiao Tong University School of Medicine, Fudan University, Shanghai Tongji Hospital, Tongji University School of Medicine, Changhai Hospital, Second Affiliated Hospital of Nanchang University