Clinical Study of Combined Platelet Transfusion

NCT ID: NCT06613425

Last Updated: 2024-09-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2025-10-28

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

Conditions

Hematologic Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

Combined platelet

Group Type: EXPERIMENTAL

Combined platelets

Intervention Type: COMBINATION_PRODUCT

1 therapeutic dose combined platelet contained no less than 2.5 ×10\^11 platelets as a quality standard.

Interventions

Combined platelets

1 therapeutic dose combined platelet contained no less than 2.5 ×10\^11 platelets as a quality standard.

Intervention Type: COMBINATION_PRODUCT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The General Hospital of Western Theater Command

OTHER

Sponsor Role: lead

Responsible Party

zhang li

PHD，Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

zhang li

Role: PRINCIPAL_INVESTIGATOR

The General Hospital of Weastern Theater Command

Locations

Li Zhang

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

zhang li

Role: CONTACT

1062747632@qq.com

+86 13982283001

Facility Contacts

zhang li

Role: primary

1062747632@qq.com

+86 13982283001

Other Identifiers

2024EC4-ky004

Identifier Type: -

Identifier Source: org_study_id