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RECRUITINGPhase 2 / Phase 3INTERVENTIONAL

The Effect of REcombinant Human Thrombopoietin (rhTPO) on Sepsis Patients With aCUte Severe thrombocytopEnia

The Effect of Recombinant Human Thrombopoietin(rhTPO) on Sepsis Patients With Acute Severe Thrombocytopenia：a Prospective, Multi-center, Open-label, ,Randomized, Controlled Trial

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Confirmed or clinical diagnosed infection 2. The change of Sequential Organ Failure Assessment(ΔSOFA) score ≥ 2 3. PLT\< 50×10\^9/L 4. willing to sign a consent form Who Should NOT Join This Trial: 1. History of the treatments with chemotherapeutic drugs or heparin within six months 2. History of bone marrow stem cell disorders, malignancy, or immunologic diseases 3. History of bone marrow, lung, liver, kidney, pancreas, or small bowel transplantation. 4. Confirmed End-stage renal failure(GFR \<10ml/min，Scr\>707μmol/L) 5. Confirmed Disseminated Intravascular Coagulation(DIC) 6. Confirmed Hemorrhagic brain injury or need craniocerebral operation 7. Died anticipated within 24 hours 8. Known pregnancy or at breastfeeding Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Confirmed or clinical diagnosed infection 2. The change of Sequential Organ Failure Assessment(ΔSOFA) score ≥ 2 3. PLT\< 50×10\^9/L 4. Informed consent Exclusion Criteria: 1. History of the treatments with chemotherapeutic drugs or heparin within six months 2. History of bone marrow stem cell disorders, malignancy, or immunologic diseases 3. History of bone marrow, lung, liver, kidney, pancreas, or small bowel transplantation. 4. Confirmed End-stage renal failure(GFR \<10ml/min，Scr\>707μmol/L) 5. Confirmed Disseminated Intravascular Coagulation(DIC) 6. Confirmed Hemorrhagic brain injury or need craniocerebral operation 7. Died anticipated within 24 hours 8. Known pregnancy or at breastfeeding

Treatments Being Tested

DRUG

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

DRUG

Placebo

The control group will not use any platelet-increased drugs.

Locations (1)

Shanghai General Hospital, Shanghai Jiaotong University
Shanghai, Shanghai Municipality, China