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Recruiting Phase 2, Phase 3 NCT02707497

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

Trial Parameters

Condition Sepsis
Sponsor Ruilan Wang
Study Type INTERVENTIONAL
Phase Phase 2, Phase 3
Enrollment 200
Sex ALL
Min Age 18 Years
Max Age 85 Years
Start Date 2019-04-01
Completion 2024-08-31
Interventions
rhTPOPlacebo

Brief 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 Criteria

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

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