NCT05761457

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 9, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2025

Completed
Last Updated

March 9, 2023

Status Verified

January 1, 2023

Enrollment Period

1.9 years

First QC Date

January 28, 2023

Last Update Submit

March 7, 2023

Conditions

Platelet Transfusion Refractoriness

Keywords

cryopreserved autologous platelet

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (2)

  • Time of platelet recovery after chemotherapy

    1 month

  • The overall incidence of PTR

    2 years

Study Arms (1)

Treatment group

EXPERIMENTAL

Patients receive cryopreserved autologous platelet transfusion

Other: Cryopreserved autologous platelet transfusion

Interventions

Cryopreserved autologous platelet transfusionOTHER

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

Treatment group

Eligibility Criteria

Age15 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

RECRUITING

Related Publications (3)

  • 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.

    PMID: 27739150BACKGROUND

  • 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.

    PMID: 7578522BACKGROUND

  • 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.

    PMID: 661855BACKGROUND

Study Officials

  • Yue Han, PhD,MD

    First Affiliated Hospital of Soochow University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yue Han, PhD,MD

CONTACT

13901551669hanyue@suda.edu.cn

Depei Wu, PhD,MD

CONTACT

13951102021wdepeisz@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Prospective, single arm and multicenter study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2023

First Posted

March 9, 2023

Study Start

March 1, 2023

Primary Completion

January 10, 2025

Study Completion

January 10, 2025

Last Updated

March 9, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)