Effects of Recombinant Human Thrombopoietin on Platelet Levels in ICU Patients

Nanfang Hospital, Southern Medical University

Status and phase: Unknown; Phase 4

Conditions: Thrombocytopenia; Pneumonia

Treatments: Drug: recombinant human thrombopoietin; Drug: normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT05217719

nfyicu005

Details and patient eligibility

About

The incidence of thrombocytopenia in ICU patients with severe illness ranged from 8.3% to 67.6%, and ranged from 14% to 44% during ICU treatment.Severe patients with thrombocytopenia also have significantly increased bleeding events and blood transfusions, and even a significantly increased risk of death.This study examines whether elevated platelets benefit patients with pneumonia

Enrollment: 178 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of pneumonia (community acquired pneumonia, hospital acquired pneumonia or ventilator associated pneumonia);
• Voluntarily signed informed consent;
• ≥18 years old;
• Platelet count ≤75×109/L

Exclusion criteria

• A history of hematopoietic stem cell transplantation or solid organ transplantation such as liver, kidney or lung;
• Hematological malignancy;
• Immune thrombocytopenia, such as SLE, ITP, TTP, etc.
• The length of stay in ICU is less than 24h;
• Pregnant or lactation patients;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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178 participants in 2 patient groups, including a placebo group

the TPO group

Experimental group

Description:

Patients in TPO group will be treated with rhTPO at a dose of 15000u/d, subcutaneous injection, for 7 consecutive days.

Treatment:

Drug: recombinant human thrombopoietin

the control group

Placebo Comparator group

Description:

Patients in the control group will receive the same amount of saline as a placebo, which is injected subcutaneously, for 7 consecutive days.

Treatment:

Drug: normal saline