Clinical Study of Combined Platelet Transfusion

NCT06613425 | Recruiting Phase 4

• 1 other identifier: 2024EC4-ky004
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematologic Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Adverse reactions of blood transfusion

  From the start of infusion of combined platelets to 6 months later

• Safety evaluation of combined platelet transfusion

  From the start of infusion of combined platelets to 6 months later

• Platelet antibody screening

  From the start of infusion of combined platelets to 6 months later

• Adverse events of blood transfusion

  From the start of infusion of combined platelets to 6 months later

• Waiting time for platelet transfusion

  From the start of infusion of combined platelets to 6 months later

Study Arms (1)

Experimental group

EXPERIMENTAL

Combined platelet

Combination Product: Combined platelets

Interventions

Combined platelets COMBINATION_PRODUCT

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

Experimental group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. 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

Sponsors & Collaborators

• The General Hospital of Western Theater Command: lead

Study Sites (1)

Li Zhang

Chengdu, Sichuan, 610083, China

RECRUITING

MeSH Terms

Conditions

Hematologic Diseases

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Study Officials

• zhang li

  The General Hospital of Weastern Theater Command

  PRINCIPAL INVESTIGATOR

Central Study Contacts

zhang li

CONTACT

+86 13982283001; 1062747632@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD，Professor

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: September 26, 2024
• Study Start: August 1, 2024
• Primary Completion: July 29, 2025
• Study Completion: October 28, 2025
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)