NCT06613425

Clinical Study of Combined Platelet Transfusion

Combined Platelet Transfusion:A Single-arm, Open, Prospective, Non-inferiority Clinical Trial

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: The General Hospital of Western Theater Command · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Platelet transfusion is an irreplaceable and important treatment method for clinical prevention and treatment of thrombocytopenia or platelet dysfunction. Due to various factors, it is difficult to achieve platelet ABO complete homotypic transfusion in clinical practice. When ABO-compatible platelets cannot be obtained, plasma-reduced platelets, platelets with low anti-A or anti-B titers are often used in clinical practice to reduce the risk of ABO-incompatible platelet-compatible transfusion reactions. The combined platelets prepared in this study can achieve ABO primary and secondary side compatible infusion.

Detailed description

Combined platelet transfusion is a single-arm, open, prospective, non-inferiority study initiated by researchers. Patients with hematological diseases who were admitted to the research unit and applied for platelet transfusion within two years were included in the study after informed consent. When the subjects applied for platelet transfusion during the study period, ABO homotype platelet transfusion was preferred. When there was no ABO homotype platelet in the inventory, ABO primary and secondary side compatible combined platelet transfusion was given. The study period was 2 years, including 15 months of enrollment, 6 months of treatment, and 3 months of follow-up after the end of the treatment period

Conditions

• Hematologic Diseases

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Combined platelets	1 therapeutic dose combined platelet contained no less than 2.5 ×10\^11 platelets as a quality standard.

Timeline

• Start date: 2024-08-01
• Primary completion: 2025-07-29
• Completion: 2025-10-28
• First posted: 2024-09-26
• Last updated: 2024-09-26

Locations

1 site across 1 country: China