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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Combined platelet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined platelets | Combination Product | 1 therapeutic dose combined platelet contained no less than 2.5 ×10^11 platelets as a quality standard. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 ). | From the start of infusion of combined platelets to 6 months later |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the start of infusion of combined platelets to 6 months later |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| zhang li | Contact | +86 13982283001 | 1062747632@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| zhang li | The General Hospital of Weastern Theater Command | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Li Zhang | Recruiting | Chengdu | Sichuan | 610083 | China |
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| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| ID | Term |
|---|---|
| D006425 | Hemic and Lymphatic Diseases |
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| 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. | 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. | 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. | 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 | 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. | 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. | From the start of infusion of combined platelets to 6 months later |