A Phase 4 interventional study of Combined platelets in Hematologic Diseases, sponsored by The General Hospital of Western Theater Command. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by The General Hospital of Western Theater Command · Phase 4, Interventional, and Health services research
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.
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
460 studies on the registry are indexed under Hematologic Diseases; 105 are open to participants now.
This study's enrollment of 266 is above the median of 50 across 274 interventional studies indexed under Hematologic Diseases.
Browse Hematologic Diseases studies →The General Hospital of Western Theater Command is the lead sponsor of 11 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
Combined platelet
Combination Product: Combined platelets
1 therapeutic dose combined platelet contained no less than 2.5 ×10\^11 platelets as a quality standard.
Efficacy evaluation of combined platelet transfusion
The platelet count was measured before blood transfusion and 1 hour and 24 hours after blood transfusion, and the WHO bleeding grade was recorded. The platelet incremental correction index ( CCI ) was calculated at 1 hour and 24 hours after infusion. CCI \> 7.5 at 1 hour, CCI \> 4.5 at 24 hours, or the control or improvement of WHO bleeding symptoms after infusion were effective for infusion. CCI = ( PLT after infusion-PLT before infusion ) × body surface area ( m2 ) × 1000 / total platelet count ( × 1011 ), body surface area = 0.0061 × height ( cm ) + 0.0128 × weight ( Kg ) - 0.1529. PPR ( % ) = ( PLT after infusion-PLT before infusion ) × blood volume ( L ) × 100 % / total platelet count × 2 / 3, blood volume = 0.07 × body weight ( Kg ).
Time frame: From the start of infusion of combined platelets to 6 months later
Adverse reactions of blood transfusion
During and after blood transfusion, the occurrence time, type, treatment and recovery time of adverse reactions of blood transfusion were collected and recorded, as well as the occurrence time, type, treatment and recovery time of adverse events of blood transfusion.
Time frame: From the start of infusion of combined platelets to 6 months later
Safety evaluation of combined platelet transfusion
Blood transfusion-related infectious markers ( HBsAg, HBV DNA, anti-HCV, HCV RNA, HIV Ag / Ab, HIV RNA, anti-TP ) were detected before and after the last blood transfusion.
Time frame: From the start of infusion of combined platelets to 6 months later
Platelet antibody screening
Platelet antibodies of the subjects were screened before blood transfusion and at the end of the intermediate follow-up period during infusion.
Time frame: From the start of infusion of combined platelets to 6 months later
Adverse events of blood transfusion
The occurrence of adverse transfusion events in the whole process of combined platelet transfusion : time, place, type, measures and consequences.
Time frame: From the start of infusion of combined platelets to 6 months later
Waiting time for platelet transfusion
The time from the clinical submission of platelet transfusion application to the start of platelet transfusion
Time frame: From the start of infusion of combined platelets to 6 months later
Interval time, frequency and total amount of platelet transfusion
The interval time, frequency and total amount of platelet transfusion in the enrolled group were recorded.
Time frame: From the start of infusion of combined platelets to 6 months later
Bleeding adverse events during hospitalization
The number of bleeding, symptoms and treatment measures during hospitalization were recorded.
Time frame: From the start of infusion of combined platelets to 6 months later
Plan to share: No
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The General Hospital of Western Theater Command