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Clinical Trials/NCT05761457
NCT05761457
Recruiting
Not Applicable

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

The First Affiliated Hospital of Soochow University1 site in 1 country25 target enrollmentStarted: March 1, 2023Last updated:
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ConditionsPlatelet Transfusion Refractoriness

Overview

Phase
Not Applicable
Status
Recruiting
Sponsor
The First Affiliated Hospital of Soochow University
Enrollment
25
Locations
1
Primary Endpoint
Incidence of adverse events after blood transfusion
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
15 Years to 70 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Incidence of adverse events after blood transfusion

Time Frame: 1 hour

The frequency or number of effective infusions (1h CCI>7.5, 24h CCI>4.5)

Time Frame: 24 hours after transfusion

Corrected count increment，CCI

The total platelet transfusion volume

Time Frame: 1 month

The CCI value of 1h and 24h after cryopreserved autologous platelet transfusion

Time Frame: 24 hours after transfusion

Platelet level detection

Secondary Outcomes

  • Time of platelet recovery after chemotherapy(1 month)
  • The overall incidence of PTR(2 years)

Investigators

Sponsor
The First Affiliated Hospital of Soochow University
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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