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

NCT02707497 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-04-18

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Huadong Hospital

    collaborator OTHER
  • Shanghai Tongji Hospital, Tongji University School of Medicine

    collaborator OTHER
  • Changhai Hospital

    collaborator OTHER
  • Second Affiliated Hospital of Nanchang University

    collaborator OTHER
  • Shanghai Jiao Tong University School of Medicine

    collaborator OTHER
  • Shanghai University of Traditional Chinese Medicine

    collaborator OTHER
  • Fudan University

    collaborator OTHER
  • Ruilan Wang

    lead OTHER

Principal Investigators

  • Ruilan Wang, MD,PhD · The department of ICU, Shanghai General Hospital, Shanghai Jiaotong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2024-08-31
Completion
2024-09-30

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02707497 on ClinicalTrials.gov