Efficacy and Safety of Autologous Cryopreserved Platelets in Patients With PTR

Platelet Transfusion Refractoriness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05761457
• Other study ID #: 20221108091732885
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: January 10, 2025

Study information

• Verified date: January 2023
• Source: The First Affiliated Hospital of Soochow University
• Contact: Yue Han, PhD,MD
• Phone: 13901551669
• Email: hanyue[@]suda.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: January 10, 2025
• Est. primary completion date: January 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Platelet Transfusion Refractoriness

Intervention

Other:
• 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.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

References & 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The CCI value of 1h and 24h after cryopreserved autologous platelet transfusion	Platelet level detection	1 hour after transfusion
Primary	The CCI value of 1h and 24h after cryopreserved autologous platelet transfusion	Platelet level detection	24 hours after transfusion
Primary	The frequency or number of effective infusions (1h CCI>7.5, 24h CCI>4.5)	Corrected count increment,CCI	1 hour after transfusion
Primary	The frequency or number of effective infusions (1h CCI>7.5, 24h CCI>4.5)	Corrected count increment,CCI	24 hours after transfusion
Primary	The total platelet transfusion volume		1 month
Primary	Incidence of adverse events after blood transfusion		1 hour
Secondary	Time of platelet recovery after chemotherapy		1 month
Secondary	The overall incidence of PTR		2 years