Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2025-12-27 @ 1:11 AM
Study NCT ID:
NCT05761457
Status:
UNKNOWN
Last Update Posted:
2023-03-09
First Post:
2023-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Autologous Cryopreserved Platelets in Patients With PTR
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective, single arm and multicenter study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2025-01-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-07', 'studyFirstSubmitDate': '2023-01-28', 'studyFirstSubmitQcDate': '2023-03-07', 'lastUpdatePostDateStruct': {'date': '2023-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The CCI value of 1h and 24h after cryopreserved autologous platelet transfusion', 'timeFrame': '1 hour after transfusion', 'description': 'Platelet level detection'}, {'measure': 'The CCI value of 1h and 24h after cryopreserved autologous platelet transfusion', 'timeFrame': '24 hours after transfusion', 'description': 'Platelet level detection'}, {'measure': 'The frequency or number of effective infusions (1h CCI>7.5, 24h CCI>4.5)', 'timeFrame': '1 hour after transfusion', 'description': 'Corrected count increment，CCI'}, {'measure': 'The frequency or number of effective infusions (1h CCI>7.5, 24h CCI>4.5)', 'timeFrame': '24 hours after transfusion', 'description': 'Corrected count increment，CCI'}, {'measure': 'The total platelet transfusion volume', 'timeFrame': '1 month'}, {'measure': 'Incidence of adverse events after blood transfusion', 'timeFrame': '1 hour'}], 'secondaryOutcomes': [{'measure': 'Time of platelet recovery after chemotherapy', 'timeFrame': '1 month'}, {'measure': 'The overall incidence of PTR', 'timeFrame': '2 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cryopreserved autologous platelet'], 'conditions': ['Platelet Transfusion Refractoriness']}, 'referencesModule': {'references': [{'pmid': '27739150', 'type': 'BACKGROUND', '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.'}, {'pmid': '7578522', 'type': 'BACKGROUND', '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.'}, {'pmid': '661855', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with ALL，AML，MDS, CML,CLL that suffered from PTR before, with or without HLA antibodies\n* The platelet level \\>150\\*10E9/L when considering autologous PLT collection\n* Age less than 70 years\n* The expected life more than 3 months\n* Agree to receive autologous platelet cryopreservation and infusion treatment, and sign the informed consent form\n\nExclusion Criteria:\n\n* Blast cells are found in peripheral blood or bone marrow\n* Patients with bacteremia or sepsis\n* Coagulation function abnormality\n* Patients who have a history of thrombosis and are receiving anticoagulant treatment\n* Severe bleeding within 2 weeks\n* Participate in another clinical study within 1 month, and have treatment with potential impact on platelets\n* Patients with mental disease'}, 'identificationModule': {'nctId': 'NCT05761457', 'briefTitle': 'Efficacy and Safety of Autologous Cryopreserved Platelets in Patients With PTR', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Soochow University'}, 'officialTitle': 'Efficacy and Safety of Autologous Cryopreserved Platelets in Patients With Platelet Refractoriness', 'orgStudyIdInfo': {'id': '20221108091732885'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'description': 'Patients receive cryopreserved autologous platelet transfusion', 'interventionNames': ['Other: Cryopreserved autologous platelet transfusion']}], 'interventions': [{'name': 'Cryopreserved autologous platelet transfusion', 'type': 'OTHER', 'description': 'Autologous PLTs were collected and transfused as an individualized treatment approach, when the platelet is less than 20\\*10E9/L or severe bleeding occurred.', 'armGroupLabels': ['Treatment group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Suzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yue Han, PhD,MD', 'role': 'CONTACT', 'email': 'hanyue@suda.edu.cn', 'phone': '13901551669'}, {'name': 'Yue Han, PhD,MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'First Affiliated Hospital of Soochow University', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}], 'centralContacts': [{'name': 'Yue Han, PhD,MD', 'role': 'CONTACT', 'email': 'hanyue@suda.edu.cn', 'phone': '13901551669'}, {'name': 'Depei Wu, PhD,MD', 'role': 'CONTACT', 'email': 'wdepeisz@163.com', 'phone': '13951102021'}], 'overallOfficials': [{'name': 'Yue Han, PhD,MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Affiliated Hospital of Soochow University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Soochow University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}