Effects of Recombinant Human Thrombopoietin on Platelet Levels in ICU Patients With Pneumonia With Thrombocytopenia: a Multicenter, Single-blind, Randomized Controlled Study
Trial Snapshot
- Phase
- Phase 4
- Enrollment
- 178
- Primary Endpoint
- The time to recovery to a normal platelet level
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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;
Arms & Interventions
the TPO group
Patients in TPO group will be treated with rhTPO at a dose of 15000u/d, subcutaneous injection, for 7 consecutive days.
Intervention: recombinant human thrombopoietin (Drug)
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.
Intervention: normal saline (Drug)
Outcomes
Primary Outcomes
The time to recovery to a normal platelet level
Time Frame: 14 days
The clinical recovery time of platelets was defined as the time it takes to reach clinical recovery.
Secondary Outcomes
No secondary outcomes reported
Investigators
Zhenhua Zen
Associate Professor
Nanfang Hospital, Southern Medical University