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Efficacy and Safety of Autologous Cryopreserved Platelets in Patients With PTR

S

Soochow University

Status

Enrolling

Conditions

Platelet Transfusion Refractoriness

Treatments

Other: Cryopreserved autologous platelet transfusion

Study type

Interventional

Funder types

Other

Identifiers

NCT05761457
20221108091732885

Details and patient eligibility

About

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.

Enrollment

25 estimated patients

Sex

All

Ages

15 to 70 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

25 participants in 1 patient group

Treatment group
Experimental group
Description:
Patients receive cryopreserved autologous platelet transfusion
Treatment:
Other: Cryopreserved autologous platelet transfusion

Trial contacts and locations

1

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Central trial contact

Yue Han, PhD,MD; Depei Wu, PhD,MD

Data sourced from clinicaltrials.gov

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