Study of Combined Platelet Transfusion for Adults With Hematologic Diseases A Single-Arm, Open, Prospective Phase 4 Clinical Trial

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 1011 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-AB 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.

Clinical Study of Combined Platelet Transfusion