Effects of Recombinant Human Thrombopoietin on Platelet Levels in ICU Patients

Effects of Recombinant Human Thrombopoietin on Platelet Levels in ICU Patients With Pneumonia With Thrombocytopenia: a Multicenter, Single-blind, Randomized Controlled Study

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

Study Overview

• Status: Not yet recruiting
• Conditions: Pneumonia; Thrombocytopenia
• Intervention / Treatment: Drug: recombinant human thrombopoietin; Drug: normal saline

• Study Type: Interventional
• Enrollment (Anticipated): 178
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Zhenhua Zeng; Phone Number: 15692428912; Email: zengzhenhua@smu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: the TPO group; Patients in TPO group will be treated with rhTPO at a dose of 15000u/d, subcutaneous injection, for 7 consecutive days.	Drug: recombinant human thrombopoietin; The dose of rhTPO is 15,000 U per day. The subcutaneous injection will be terminated when PCs are increased to normal. The duration of rhTPO will be 7 days.
Placebo Comparator: the control group; Patients in the control group will receive the same amount of saline as a placebo, which is injected subcutaneously, for 7 consecutive days.	Drug: normal saline; Patients in the control group will receive the same amount of saline as a placebo, which is injected subcutaneously. The duration of saline will be 7 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The time to recovery to a normal platelet level	The clinical recovery time of platelets was defined as the time it takes to reach clinical recovery.	14 days

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University
• Collaborators: The Third Affiliated Hospital of Southern Medical University; The Second People's Hospital of GuangDong Province; Shenzhen Hospital of Southern Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2022
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: January 19, 2022
• First Submitted That Met QC Criteria: January 19, 2022
• First Posted (Actual): February 1, 2022

Study Record Updates

• Last Update Posted (Actual): February 1, 2022
• Last Update Submitted That Met QC Criteria: January 19, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Hematologic Diseases; Blood Platelet Disorders; Pneumonia; Thrombocytopenia
• Other Study ID Numbers: nfyicu005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No