Efficacy and Safety of Autologous Cryopreserved Platelets in Patients With PTR

Not Applicable

Recruiting

• Conditions: Platelet Transfusion Refractoriness
• Interventions: Other: Cryopreserved autologous platelet transfusion

• 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

Arm && Interventions

Group	Intervention	Description
Treatment group	Cryopreserved autologous platelet transfusion	Patients receive cryopreserved autologous platelet transfusion

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events after blood transfusion	1 hour
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
The CCI value of 1h and 24h after cryopreserved autologous platelet transfusion	24 hours after transfusion	Platelet level detection

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