Efficacy and Safety of Autologous Cryopreserved Platelets in Patients With PTR

Not Applicable

Recruiting

• Conditions: Platelet Transfusion Refractoriness

• Registration Number: NCT05761457
• Lead Sponsor: The First Affiliated Hospital of Soochow University

Brief Summary

The purpose of this study is to improve the platelet level of PTR patients; Prevent and improve bleeding; Help patients to successfully through the bone marrow suppression period after chemotherapy; Reduce the overall rate of PTR and allo-immunity; Saving platelet resources and reducing blood burden.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-01-28
• Study Start: 2023-03-01
• Study First Submitted QC: 2023-03-07
• Last Update Submitted: 2023-03-07
• Study First Posted: 2023-03-09
• Last Update Posted: 2023-03-09
• Primary Completion: 2025-01-10
• Study Completion: 2025-01-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Patients with ALL，AML，MDS, CML,CLL that suffered from PTR before, with or without HLA antibodies
• The platelet level >150*10E9/L when considering autologous PLT collection
• Age less than 70 years
• The expected life more than 3 months
• Agree to receive autologous platelet cryopreservation and infusion treatment, and sign the informed consent form

Exclusion Criteria

• Blast cells are found in peripheral blood or bone marrow
• Patients with bacteremia or sepsis
• Coagulation function abnormality
• Patients who have a history of thrombosis and are receiving anticoagulant treatment
• Severe bleeding within 2 weeks
• Participate in another clinical study within 1 month, and have treatment with potential impact on platelets
• Patients with mental disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events after blood transfusion	1 hour
The CCI value of 1h and 24h after cryopreserved autologous platelet transfusion	24 hours after transfusion	Platelet level detection
The frequency or number of effective infusions (1h CCI>7.5, 24h CCI>4.5)	24 hours after transfusion	Corrected count increment，CCI
The total platelet transfusion volume	1 month

Secondary Outcome Measures

Name	Time	Method
Time of platelet recovery after chemotherapy	1 month
The overall incidence of PTR	2 years

Trial Locations

Locations (1)

First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China