Effects of Recombinant Human Thrombopoietin on Platelet Levels in ICU Patients

Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05217719
• Other study ID #: nfyicu005
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: February 2022
• Est. completion date: October 2023

Study information

• Verified date: January 2022
• Source: Nanfang Hospital of Southern Medical University
• Contact: Zhenhua Zeng
• Phone: 15692428912
• Email: zengzhenhua[@]smu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 178
• Est. completion date: October 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Pneumonia
• Thrombocytopenia

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University	Shenzhen Hospital of Southern Medical University, The Second People's Hospital of GuangDong Province, The Third Affiliated Hospital of Southern Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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