Efficacy and Safety of Autologous Cryopreserved Platelets in Patients With PTR

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety of Autologous Cryopreserved Platelets in Patients With Platelet Refractoriness

Conditions
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Platelet Transfusion Refractoriness

Intervention / Treatment
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* Other: Cryopreserved autologous platelet transfusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, single arm and multicenter study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Patients receive cryopreserved autologous platelet transfusion | Other: Cryopreserved autologous platelet transfusion<br>* Autologous PLTs were collected and transfused as an individualized treatment approach, when the platelet is less than 20*10E9/L or severe bleeding occurred.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of platelet recovery after chemotherapy |  | 1 month | 
| The overall incidence of PTR |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cryopreserved autologous platelet