Effects of Recombinant Human Thrombopoietin on Platelet Levels in ICU Patients

NCT ID: NCT05217719

Last Updated: 2022-02-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 178 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-28
• Study Completion Date: 2023-10-31

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

Conditions

Pneumonia; Thrombocytopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

the TPO group

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

Group Type: EXPERIMENTAL

recombinant human thrombopoietin

Intervention Type: DRUG

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.

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.

Group Type: PLACEBO_COMPARATOR

normal saline

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Third Affiliated Hospital of Southern Medical University

OTHER_GOV

Sponsor Role: collaborator

The Second People's Hospital of GuangDong Province

OTHER

Sponsor Role: collaborator

Shenzhen Hospital of Southern Medical University

OTHER

Sponsor Role: collaborator

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Zhenhua Zen

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Zhenhua Zeng

Role: CONTACT

zengzhenhua@smu.edu.cn

15692428912

Other Identifiers

nfyicu005

Identifier Type: -

Identifier Source: org_study_id