Effects of Recombinant Human Thrombopoietin on Platelet Levels in ICU Patients

NCT05217719 | Unknown Phase 4

• 1 other identifier: nfyicu005
• Study Type: interventional
• Target: 178
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

the TPO group

EXPERIMENTAL

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 control group

PLACEBO COMPARATOR

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

Interventions

recombinant human thrombopoietin 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 TPO group

normal saline 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.

the control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead
• The Third Affiliated Hospital of Southern Medical University: collaborator
• The Second People's Hospital of GuangDong Province: collaborator
• Shenzhen Hospital of Southern Medical University: collaborator

MeSH Terms

Conditions

Pneumonia; Thrombocytopenia

Interventions

Thrombopoietin; Saline Solution

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Zhenhua Zeng

CONTACT

15692428912; zengzhenhua@smu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: February 1, 2022
• Study Start: February 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: October 1, 2023
• Last Updated: February 1, 2022

Record last verified: 2022-01