Back to resultsEffects of Recombinant Human Thrombopoietin on Platelet Levels in ICU Patients
Primary Purpose
Pneumonia, Thrombocytopenia
Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
recombinant human thrombopoietin
normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Pneumonia
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;
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
the TPO group
the control group
Arm Description
Patients in TPO group will be treated with rhTPO at a dose of 15000u/d, subcutaneous injection, for 7 consecutive days.
Patients in the control group will receive the same amount of saline as a placebo, which is injected subcutaneously, for 7 consecutive days.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05217719
First Posted
January 19, 2022
Last Updated
January 19, 2022
Sponsor
Nanfang Hospital, 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
1. Study Identification
Unique Protocol Identification Number
NCT05217719
Brief Title
Effects of Recombinant Human Thrombopoietin on Platelet Levels in ICU Patients
Official Title
Effects of Recombinant Human Thrombopoietin on Platelet Levels in ICU Patients With Pneumonia With Thrombocytopenia: a Multicenter, Single-blind, Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 2022 (Anticipated)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanfang Hospital, 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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Thrombocytopenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
178 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
the TPO group
Arm Type
Experimental
Arm Description
Patients in TPO group will be treated with rhTPO at a dose of 15000u/d, subcutaneous injection, for 7 consecutive days.
Arm Title
the control group
Arm Type
Placebo Comparator
Arm Description
Patients in the control group will receive the same amount of saline as a placebo, which is injected subcutaneously, for 7 consecutive days.
Intervention Type
Drug
Intervention Name(s)
recombinant human thrombopoietin
Intervention Description
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
Intervention Name(s)
normal saline
Intervention Description
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.
Primary Outcome Measure Information:
Title
The time to recovery to a normal platelet level
Description
The clinical recovery time of platelets was defined as the time it takes to reach clinical recovery.
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhenhua Zeng
Phone
15692428912
Email
zengzhenhua@smu.edu.cn
12. IPD Sharing Statement
Learn more about this trial
Effects of Recombinant Human Thrombopoietin on Platelet Levels in ICU Patients
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