Clinical trial NCT06613425: Clinical Study of Combined Platelet Transfusion
Official title: Combined Platelet Transfusion:A Single-arm, Open, Prospective, Non-inferiority Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Hematologic Diseases
Lead sponsor: The General Hospital of Western Theater Command
Sponsor class: OTHER
First posted: 2024-09-26
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: Inclusion Criteria:

* 1. Aged 18-65 years; 2. Disease treatment in the research hospital; 3. Applied for platelet transfusion therapy.

Exclusion Criteria:

* 1. One month before the start of this study, he participated in other clinical trials of drugs and instruments related to platelet transfusion efficacy; 2. Without platelet transfusion indications; 3. Only received platelet transfusion in the outpatient department and left the hospital without efficacy evaluation after transfusion; 4. Gave up platelet transfusion therapy for any reason after enrollment; 5. Transferred or discharged from hospital for any reason before platelet transfusion after enrollment; 6. Did not receive combined platelet transfusion during the 6-month treatment period after enrollment

Primary outcomes:
measure: Efficacy evaluation of combined platelet transfusion
timeFrame: From the start of infusion of combined platelets to 6 months later
Secondary outcomes:
measure: Adverse reactions of blood transfusion
timeFrame: From the start of infusion of combined platelets to 6 months later
measure: Safety evaluation of combined platelet transfusion
timeFrame: From the start of infusion of combined platelets to 6 months later
measure: Platelet antibody screening
timeFrame: From the start of infusion of combined platelets to 6 months later
measure: Adverse events of blood transfusion
timeFrame: From the start of infusion of combined platelets to 6 months later
measure: Waiting time for platelet transfusion
timeFrame: From the start of infusion of combined platelets to 6 months later
measure: Interval time, frequency and total amount of platelet transfusion
timeFrame: From the start of infusion of combined platelets to 6 months later
measure: Bleeding adverse events during hospitalization
timeFrame: From the start of infusion of combined platelets to 6 months later
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Li Zhang
state: Sichuan
Study officials:
affiliation: The General Hospital of Weastern Theater Command
name: zhang li
role: PRINCIPAL_INVESTIGATOR
References: