Platelet Transfusion RefractorinessNCT05761457
Efficacy and Safety of Autologous Cryopreserved Platelets in Patients With PTR
A study testing Cryopreserved autologous platelet transfusion in people with Platelet Transfusion Refractoriness, run by The First Affiliated Hospital of Soochow University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Platelet Transfusion Refractoriness
- What is being tested?
- Cryopreserved autologous platelet transfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 10 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Soochow University
Suzhou, Jiangsu
Yue Han, PhD,MD, 13901551669, hanyue@suda.edu.cn
Yue Han, PhD,MD
About this study
Official title: Efficacy and Safety of Autologous Cryopreserved Platelets in Patients With Platelet Refractoriness
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.
- Conditions
- Platelet Transfusion Refractoriness
- Being tested
- Cryopreserved autologous platelet transfusion
- Keywords
- cryopreserved autologous platelet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Patients receive cryopreserved autologous platelet transfusion Receives: Other: Cryopreserved autologous platelet transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
The CCI value of 1h and 24h after cryopreserved autologous platelet transfusion
Platelet level detection
Measured: 1 hour after transfusion
The CCI value of 1h and 24h after cryopreserved autologous platelet transfusion
Platelet level detection
Measured: 24 hours after transfusion
The frequency or number of effective infusions (1h CCI>7.5, 24h CCI>4.5)
Corrected count increment，CCI
Measured: 1 hour after transfusion
The frequency or number of effective infusions (1h CCI>7.5, 24h CCI>4.5)
Corrected count increment，CCI
Measured: 24 hours after transfusion
The total platelet transfusion volume
Measured: 1 month
Incidence of adverse events after blood transfusion
Measured: 1 hour
Secondary outcomes (2)
Time of platelet recovery after chemotherapy
Measured: 1 month
The overall incidence of PTR
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start1 Mar 2023 (estimated)
- Primary completion10 Jan 2025 (estimated)
- Study completion10 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Platelet Transfusion RefractorinessStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single arm and multicenter study
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yue Han, PhD,MD, Principal investigator, First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05761457
- Sponsor's protocol ID
- 20221108091732885
- Status last verified
- Jan 2023
- First submitted
- 28 Jan 2023
- Last updated
- 9 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 27739150Funke 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.
PubMed 7578522Schiffer 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.
PubMed 661855
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Autologous Cryopreserved Platelets in Patients With Platelet Refractoriness
- ClinicalTrials.gov ID
- NCT05761457
- Acronym / sponsor ID
- 20221108091732885
- Conditions
- Platelet Transfusion Refractoriness
- Keywords
- cryopreserved autologous platelet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 10 Jan 2025 (estimated)
- Study completion
- 10 Jan 2025 (estimated)
- First posted
- 9 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single arm and multicenter study
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Other: Cryopreserved autologous platelet transfusionPatients receive cryopreserved autologous platelet transfusion |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryopreserved autologous platelet transfusionAutologous PLTs were collected and transfused as an individualized treatment approach, when the platelet is less than 20*10E9/L or severe bleeding occurred. | Other | Treatment group |
Primary outcome
The CCI value of 1h and 24h after cryopreserved autologous platelet transfusion
Time frame: 1 hour after transfusion
Platelet level detection
The CCI value of 1h and 24h after cryopreserved autologous platelet transfusion
Time frame: 24 hours after transfusion
Platelet level detection
The frequency or number of effective infusions (1h CCI>7.5, 24h CCI>4.5)
Time frame: 1 hour after transfusion
Corrected count increment，CCI
The frequency or number of effective infusions (1h CCI>7.5, 24h CCI>4.5)
Time frame: 24 hours after transfusion
Corrected count increment，CCI
The total platelet transfusion volume
Time frame: 1 month
Incidence of adverse events after blood transfusion
Time frame: 1 hour
2 secondary outcomes
Time of platelet recovery after chemotherapy
Time frame: 1 month
The overall incidence of PTR
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
- Background: PubMed 27739150Cid J. Autologous cryopreserved platelets to overcome immune platelet refractoriness. Transfusion. 2016 Oct;56(10):2403-2404. doi: 10.1111/trf.13758. No abstract available.
- Background: PubMed 7578522Funke 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.
- Background: PubMed 661855Schiffer 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.
- Individual participant dataSharing planned: No
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Not yet recruitingPhase 3
Acalabrutinib Maleate and Bortezomib for Patients With HLA Antibodies
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RecruitingPhase 2
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yue Han, PhD,MD principal investigator
First Affiliated Hospital of Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryopreserved autologous platelet transfusion in people with Platelet Transfusion Refractoriness, run by The First Affiliated Hospital of Soochow University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yue Han, PhD,MD (13901551669, hanyue@suda.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The CCI value of 1h and 24h after cryopreserved autologous platelet transfusion (time frame: 1 hour after transfusion). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05761457, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2023.