Clinical Study of Combined Platelet Transfusion

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

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.

Study Overview

• Status: Completed
• Conditions: Hematologic Diseases
• Intervention / Treatment: Combination product: Combined platelets

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

• Study Type: Interventional
• Enrollment (Actual): 266
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610083
      • Li Zhang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Combined platelet	Combination product: Combined platelets; 1 therapeutic dose combined platelet contained no less than 2.5 ×10^11 platelets as a quality standard.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: The General Hospital of Western Theater Command
• Investigators: Principal Investigator: zhang li, The General Hospital of Weastern Theater Command

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Actual): November 30, 2025
• Study Completion (Actual): March 30, 2026

Study Registration Dates

• First Submitted: August 28, 2024
• First Submitted That Met QC Criteria: September 23, 2024
• First Posted (Actual): September 26, 2024

Study Record Updates

• Last Update Posted (Actual): September 11, 2026
• Last Update Submitted That Met QC Criteria: September 8, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hemic and Lymphatic Diseases; Hematologic Diseases
• Other Study ID Numbers: 2024EC4-ky004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No