Using rhTPO to treat sepsis patients with severe low platelet counts
The Effect of Recombinant Human Thrombopoietin(rhTPO) on Sepsis Patients With Acute Severe Thrombocytopenia：a Prospective, Multi-center, Open-label, ,Randomized, Controlled Trial
This study is testing if a new treatment called rhTPO can help sepsis patients with very low platelet counts recover faster and need fewer platelet transfusions.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Academic / other |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT02707497 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of recombinant human thrombopoietin (rhTPO) on patients suffering from sepsis and severe thrombocytopenia. It aims to determine if rhTPO can quickly increase platelet counts, reduce the need for platelet transfusions, and improve overall recovery outcomes, including organ function and ICU stay duration. The study is a prospective, multi-center, open-label, randomized, controlled trial conducted across seven tertiary academic medical centers, with patient enrollment expected to last up to 30 months.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with sepsis and severe thrombocytopenia, characterized by platelet counts below 50×10^9/L.
Not a fit: Patients with a history of certain medical conditions, such as malignancies or severe renal failure, may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce mortality and improve recovery for sepsis patients with severe thrombocytopenia.
How similar studies have performed: While the use of platelet-increasing drugs is an emerging trend, this specific approach with rhTPO in sepsis patients is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai, Shanghai
- Shanghai General Hospital, Shanghai Jiaotong University — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Ruilan Wang, MD,PhD — The department of ICU, Shanghai General Hospital, Shanghai Jiaotong University
- Study coordinator: Ruilan Wang, MD,PhD
- Email: wangyusun@hotmail.com
- Phone: +86-13917138008
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.