Actively Recruiting
Combined Platelet Transfusion: A Single-Arm, Open, Prospective Study Evaluating Safety and Efficacy in Hematologic Diseases
Led by The General Hospital of Western Theater Command · Updated on 2024-09-26
86
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating combined platelet transfusion as a treatment for patients with hematologic diseases who need platelet transfusions. This study is a single-arm, open, prospective, non-inferiority trial aiming to assess whether combined platelet transfusion, which achieves ABO primary and secondary side compatible infusion, is effective and safe compared to traditional ABO homotype platelet transfusion. The study is sponsored by The General Hospital of Western Theater Command and focuses on improving platelet transfusion options when ABO-compatible platelets are not available. Participants will receive combined platelet transfusions when ABO homotype platelets are unavailable during the treatment period. Each therapeutic dose contains no less than 2.5 × 10^11 platelets. The study includes 15 months of enrollment, followed by 6 months of treatment with combined platelets, and then a 3-month follow-up period. The combined platelet transfusion aims to reduce transfusion reaction risks associated with ABO incompatibility by using plasma-reduced or low anti-A/B titer platelets. Throughout the study, participants will be monitored for efficacy and safety outcomes from the start of combined platelet infusion to 6 months later. Assessments include evaluation of treatment effectiveness, blood transfusion adverse reactions and events, safety, platelet antibody screening, waiting times, transfusion frequency, and bleeding events during hospitalization. The total participation time spans up to two years, including the treatment and follow-up periods to ensure thorough evaluation of the combined platelet transfusion approach.
CONDITIONS
Brief Title
Clinical Study of Combined Platelet Transfusion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 65 years
- Receiving disease treatment at the research hospital
- Applied for platelet transfusion therapy
You will not qualify if you...
- Participated in other clinical trials related to platelet transfusion efficacy within one month before this study
- No indication for platelet transfusion
- Only received platelet transfusion in outpatient department without evaluation after transfusion
- Gave up platelet transfusion therapy for any reason after enrollment
- Transferred or discharged from hospital before platelet transfusion after enrollment
- Did not receive combined platelet transfusion during the 6-month treatment period after enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 15 months
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Duration - 6 months
Participants receive combined platelet transfusions and are monitored for safety and efficacy during this period.
Visits occur as needed during transfusion and monitoring
Duration - 3 months
Participants are followed for safety and efficacy assessments after completion of treatment.
Follow-up visits after treatment completion
Trial Site Locations
Total: 1 location
1
Li Zhang
Chengdu, Sichuan, China, 610083
Actively Recruiting
Research Team
Z
zhang li
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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