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
Ruilan Wang
200 participants
Apr 1, 2019
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- Confirmed or clinical diagnosed infection
- The change of Sequential Organ Failure Assessment(ΔSOFA) score ≥ 2
- PLT< 50×10\^9/L
- Informed consent
Exclusion Criteria8
- History of the treatments with chemotherapeutic drugs or heparin within six months
- History of bone marrow stem cell disorders, malignancy, or immunologic diseases
- History of bone marrow, lung, liver, kidney, pancreas, or small bowel transplantation.
- Confirmed End-stage renal failure(GFR <10ml/min，Scr>707μmol/L)
- Confirmed Disseminated Intravascular Coagulation(DIC)
- Confirmed Hemorrhagic brain injury or need craniocerebral operation
- Died anticipated within 24 hours
- Known pregnancy or at breastfeeding
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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
The control group will not use any platelet-increased drugs.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT02707497