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

NCT02707497 | Recruiting Phase 2 DMC

• 1 other identifier: RWang-TPO-301
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Thrombocytopenia

Keywords

sepsis; severe thrombocytopenia; recombinant human thrombopoietin; platelets; 28-day mortality

Outcome Measures

Primary Outcomes (1)

• Mortality

  The 28-day mortality of the patients

  28 days after enrolled

Secondary Outcomes (16)

• The changes of platelets counts (PCs) in the first 7 days

  7 days after enrolled

• The clinical recovery time of PCs

  28 days after enrolled

• The amount of blood transfusion

  28 days after enrolled

• The proportion of blood transfusion

  28 days after enrolled

• The changes of procalcitonin

  28 days after enrolled

Study Arms (2)

rhTPO

EXPERIMENTAL

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: rhTPO

placebo

PLACEBO COMPARATOR

The control group will not use any platelet-increased drugs.

Drug: Placebo

Interventions

rhTPO DRUG

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

Also known as: Recombinant Human TPO

rhTPO

Placebo DRUG

The control group will not use any platelet-increased drugs.

Also known as: No platelet-increased drug

placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed or clinical diagnosed infection
• The change of Sequential Organ Failure Assessment(ΔSOFA) score ≥ 2
• PLT\< 50×10\^9/L
• Informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruilan Wang: lead
• Huadong Hospital: collaborator
• Shanghai Tongji Hospital, Tongji University School of Medicine: collaborator
• Changhai Hospital: collaborator
• Second Affiliated Hospital of Nanchang University: collaborator
• Shanghai Jiao Tong University School of Medicine: collaborator
• Shanghai University of Traditional Chinese Medicine: collaborator
• Fudan University: collaborator

Study Sites (1)

Shanghai General Hospital, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200080, China

RECRUITING

Related Publications (1)

• Zhou Z, Feng T, Xie Y, Huang P, Xie H, Tian R, Qian B, Wang R. The effect of recombinant human thrombopoietin (rhTPO) on sepsis patients with acute severe thrombocytopenia: a study protocol for a multicentre randomised controlled trial (RESCUE trial). BMC Infect Dis. 2019 Sep 6;19(1):780. doi: 10.1186/s12879-019-4388-2.

  PMID: 31492102 DERIVED

MeSH Terms

Conditions

Sepsis; Thrombocytopenia

Interventions

Thrombopoietin

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Ruilan Wang, MD,PhD

  The department of ICU, Shanghai General Hospital, Shanghai Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruilan Wang, MD,PhD

CONTACT

+86-13917138008; wangyusun@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: The director of emergency and intensive care unit

Study Record Dates

• First Submitted: March 3, 2016
• First Posted: March 14, 2016
• Study Start: April 1, 2019
• Primary Completion: August 31, 2024
• Study Completion: September 30, 2024
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: starting 6 months after publication.

Locations

CN (1)