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

• Status: Recruiting
• Trial end date: 2022-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ruilan Wang
• Collaborators: Changhai Hospital; Fudan University; Huadong Hospital; RenJi Hospital; Ruijin Hospital; Second Affiliated Hospital of Nanchang University; Shanghai Fifth People's Hospital,Fudan University; Shanghai Jiao Tong University School of Medicine; Shanghai Tongji Hospital, Tongji University School of Medicine; Shanghai University of Traditional Chinese Medicine; Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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