Clinical trial NCT05761457: Efficacy and Safety of Autologous Cryopreserved Platelets in Patients With PTR
Official title: Efficacy and Safety of Autologous Cryopreserved Platelets in Patients With Platelet Refractoriness
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Platelet Transfusion Refractoriness
Keywords: cryopreserved autologous platelet
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2023-03-09
Enrollment: 25
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, single arm and multicenter study
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The CCI value of 1h and 24h after cryopreserved autologous platelet transfusion
timeFrame: 1 hour after transfusion
measure: The CCI value of 1h and 24h after cryopreserved autologous platelet transfusion
timeFrame: 24 hours after transfusion
measure: The frequency or number of effective infusions (1h CCI>7.5, 24h CCI>4.5)
timeFrame: 1 hour after transfusion
measure: The frequency or number of effective infusions (1h CCI>7.5, 24h CCI>4.5)
timeFrame: 24 hours after transfusion
measure: The total platelet transfusion volume
timeFrame: 1 month
measure: Incidence of adverse events after blood transfusion
timeFrame: 1 hour
Secondary outcomes:
measure: Time of platelet recovery after chemotherapy
timeFrame: 1 month
measure: The overall incidence of PTR
timeFrame: 2 years
Other outcomes:
Locations:
city: Suzhou
country: China
facility: First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
affiliation: First Affiliated Hospital of Soochow University
name: Yue Han, PhD,MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.