UnknownNot Applicable

Efficacy and Safety of Autologous Cryopreserved Platelets in Patients With PTR

China25 participantsStarted 2023-03-01

Plain-language 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.

Who can participate

Age range

15 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The CCI value of 1h and 24h after cryopreserved autologous platelet transfusion

Timeframe: 1 hour after transfusion

The CCI value of 1h and 24h after cryopreserved autologous platelet transfusion

Timeframe: 24 hours after transfusion

The frequency or number of effective infusions (1h CCI>7.5, 24h CCI>4.5)

Timeframe: 1 hour after transfusion

The frequency or number of effective infusions (1h CCI>7.5, 24h CCI>4.5)

Timeframe: 24 hours after transfusion

The total platelet transfusion volume

Timeframe: 1 month

Incidence of adverse events after blood transfusion

Timeframe: 1 hour

Trial details

NCT IDNCT05761457

SponsorThe First Affiliated Hospital of Soochow University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-10

Contact for this trial

Yue Han, PhD,MD

13901551669 hanyue@suda.edu.cn

View on ClinicalTrials.gov More Platelet Transfusion Refractoriness trials

Plain-language summary

Who can participate

Age range

15 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

The CCI value of 1h and 24h after cryopreserved autologous platelet transfusion

Timeframe: 1 hour after transfusion

The CCI value of 1h and 24h after cryopreserved autologous platelet transfusion

Timeframe: 24 hours after transfusion

The frequency or number of effective infusions (1h CCI>7.5, 24h CCI>4.5)

Timeframe: 1 hour after transfusion

The frequency or number of effective infusions (1h CCI>7.5, 24h CCI>4.5)

Timeframe: 24 hours after transfusion

The total platelet transfusion volume

Timeframe: 1 month

Incidence of adverse events after blood transfusion

Timeframe: 1 hour