Efficacy and Safety of Autologous Cryopreserved Platelets in Patients With PTR

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05761457

Enrollment

Registered

2023-03-09

Start date

2023-03-01

Completion date

2025-01-10

Last updated

2023-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Platelet Transfusion Refractoriness

Keywords

cryopreserved autologous platelet

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.

Interventions

OTHERCryopreserved autologous platelet transfusion

Autologous PLTs were collected and transfused as an individualized treatment approach, when the platelet is less than 20\*10E9/L or severe bleeding occurred.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Prospective, single arm and multicenter study

Eligibility

Sex/Gender

ALL

Age

15 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Time of platelet recovery after chemotherapy	1 month
The overall incidence of PTR	2 years

Countries

China

Contacts

Primary ContactYue Han, PhD,MD

hanyue@suda.edu.cn13901551669

Backup ContactDepei Wu, PhD,MD

wdepeisz@163.com13951102021

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026