Efficacy and Safety of Autologous Cryopreserved Platelets in Patients With PTR

NCT ID: NCT05761457

Last Updated: 2023-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2025-01-10

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.

Detailed Description

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Conditions

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Platelet Transfusion Refractoriness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective, single arm and multicenter study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment group

Patients receive cryopreserved autologous platelet transfusion

Group Type EXPERIMENTAL

Cryopreserved autologous platelet transfusion

Intervention Type OTHER

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

Interventions

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Cryopreserved 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.

Intervention Type OTHER

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
Minimum Eligible Age

15 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yue Han, PhD,MD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Soochow University

Locations

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First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yue Han, PhD,MD

Role: CONTACT

13901551669

Depei Wu, PhD,MD

Role: CONTACT

13951102021

Facility Contacts

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Yue Han, PhD,MD

Role: primary

13901551669

References

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Cid J. Autologous cryopreserved platelets to overcome immune platelet refractoriness. Transfusion. 2016 Oct;56(10):2403-2404. doi: 10.1111/trf.13758. No abstract available.

Reference Type BACKGROUND
PMID: 27739150 (View on PubMed)

Funke I, Wiesneth M, Koerner K, Cardoso M, Seifried E, Kubanek B, Heimpel H. Autologous platelet transfusion in alloimmunized patients with acute leukemia. Ann Hematol. 1995 Oct;71(4):169-73. doi: 10.1007/BF01910313.

Reference Type BACKGROUND
PMID: 7578522 (View on PubMed)

Schiffer CA, Aisner J, Wiernik PH. Frozen autologous platelet transfusion for patients with leukemia. N Engl J Med. 1978 Jul 6;299(1):7-12. doi: 10.1056/NEJM197807062990102.

Reference Type BACKGROUND
PMID: 661855 (View on PubMed)

Other Identifiers

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20221108091732885

Identifier Type: -

Identifier Source: org_study_id

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