Effects of Recombinant Human Thrombopoietin on Platelet Levels in ICU Patients

Phase 4

• Conditions: Pneumonia; Thrombocytopenia
• Interventions: Drug: normal saline; Drug: recombinant human thrombopoietin

• Registration Number: NCT05217719
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-01
• Study First Submitted: 2022-01-19
• Study First Submitted QC: 2022-01-19
• Last Update Submitted: 2022-01-19
• Study Start: 2022-02
• Study First Posted: 2022-02-01
• Last Update Posted: 2022-02-01
• Primary Completion: 2023-08
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 178

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the control group	normal saline	Patients in the control group will receive the same amount of saline as a placebo, which is injected subcutaneously, for 7 consecutive days.
the TPO group	recombinant human thrombopoietin	Patients in TPO group will be treated with rhTPO at a dose of 15000u/d, subcutaneous injection, for 7 consecutive days.

Primary Outcome Measures

Name	Time	Method
The time to recovery to a normal platelet level	14 days	The clinical recovery time of platelets was defined as the time it takes to reach clinical recovery.