Efficacy and Safety of Autologous Cryopreserved Platelets in Patients With PTR

• Sponsor: The First Affiliated Hospital of Soochow University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05761457
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 22.4
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Platelet Transfusion Refractoriness	Other: Cryopreserved autologous platelet transfusion	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 25 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Prospective, single arm and multicenter studyProspective, single arm and multicenter study
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of Autologous Cryopreserved Platelets in Patients With Platelet Refractoriness
• Anticipated Study Start Date: Mar 1, 2023
• Anticipated Primary Completion Date: Jan 10, 2025
• Anticipated Study Completion Date: Jan 10, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment group Patients receive cryopreserved autologous platelet transfusion	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.

Outcome Measures

Primary Outcome Measures

1. The CCI value of 1h and 24h after cryopreserved autologous platelet transfusion [1 hour after transfusion]

   Platelet level detection

2. The CCI value of 1h and 24h after cryopreserved autologous platelet transfusion [24 hours after transfusion]

   Platelet level detection

3. The frequency or number of effective infusions (1h CCI>7.5, 24h CCI>4.5) [1 hour after transfusion]

   Corrected count increment，CCI

4. The frequency or number of effective infusions (1h CCI>7.5, 24h CCI>4.5) [24 hours after transfusion]

   Corrected count increment，CCI

5. The total platelet transfusion volume [1 month]

6. Incidence of adverse events after blood transfusion [1 hour]

Secondary Outcome Measures

1. Time of platelet recovery after chemotherapy [1 month]

2. The overall incidence of PTR [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 70 Years
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First Affiliated Hospital of Soochow University	Suzhou	Jiangsu	China

Sponsors and Collaborators

• The First Affiliated Hospital of Soochow University

Investigators

• Principal Investigator: Yue Han, PhD,MD, First Affiliated Hospital of Soochow University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: The First Affiliated Hospital of Soochow University
• ClinicalTrials.gov Identifier: NCT05761457
• Other Study ID Numbers: 20221108091732885
• First Posted: Mar 9, 2023
• Last Update Posted: Mar 9, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by The First Affiliated Hospital of Soochow University: cryopreserved autologous platelet

Study Results

No Results Posted as of Mar 9, 2023