Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2026-02-20 @ 6:38 PM
Study NCT ID:
NCT02032134
Status:
TERMINATED
Last Update Posted:
2017-10-18
First Post:
2014-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Protocol for the Infusion of Buffy Coat-derived Cryopreserved Platelets in Patients With Severe Thrombocytopenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013921', 'term': 'Thrombocytopenia'}], 'ancestors': [{'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000095542', 'term': 'Cytopenia'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004121', 'term': 'Dimethyl Sulfoxide'}], 'ancestors': [{'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'recruitment failure within the interval of available CRY BC-PLTs for the study', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-17', 'studyFirstSubmitDate': '2014-01-07', 'studyFirstSubmitQcDate': '2014-01-08', 'lastUpdatePostDateStruct': {'date': '2017-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of infused cryopreserved platelets (changes in platelets count will be determined at 1 hour and 24 hours post-transfusion)', 'timeFrame': '1 Hour and 24 hours post-transfusion', 'description': 'To evaluate the availability of cryopreserved platelets after transfusion, the correct count (the number of platelets poured and the body surface, BMI, recipient) of platelets will be determined at 1 hour and 24 hours post transfusion, respectively'}], 'secondaryOutcomes': [{'measure': 'Safety of cryopreserved platelets', 'timeFrame': 'During transfusion and within 48 hours after transfusion', 'description': 'Any transfusion-related side effect (i.e. idiosyncrasy, allergy, toxicity) will be monitored'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cryopreserved platelets, thrombocytopenia, DMSO'], 'conditions': ['Thrombocytopenia', 'Primary Thrombocytopenia,Unspecified', 'Thrombocytopenia Chemotherapy Induced']}, 'referencesModule': {'references': [{'pmid': '12493312', 'type': 'BACKGROUND', 'citation': 'Wautier JL. Safety and usefulness of autologous cryopreserved platelets. Lancet. 2002 Dec 14;360(9349):1985. doi: 10.1016/S0140-6736(02)11893-9. No abstract available.'}, {'pmid': '22781890', 'type': 'BACKGROUND', 'citation': 'Liu GQ, Ding HF, Lu XJ, Xu M, Xing J, Zhao X, Han F, Shang YH. [The efficacy and safety of autologous cryopreserved platelet transfusion in management of thrombocytopenia after chemotherapy in hematological malignancy]. Zhonghua Nei Ke Za Zhi. 2012 Mar;51(3):188-91. Chinese.'}, {'pmid': '15183900', 'type': 'BACKGROUND', 'citation': 'Heal JM, Blumberg N. Optimizing platelet transfusion therapy. Blood Rev. 2004 Sep;18(3):149-65. doi: 10.1016/S0268-960X(03)00057-2.'}, {'pmid': '1339584', 'type': 'BACKGROUND', 'citation': 'Murphy MF, Brozovic B, Murphy W, Ouwehand W, Waters AH. Guidelines for platelet transfusions. British Committee for Standards in Haematology, Working Party of the Blood Transfusion Task Force. Transfus Med. 1992 Dec;2(4):311-8. doi: 10.1111/j.1365-3148.1992.tb00175.x.'}, {'pmid': '22671278', 'type': 'BACKGROUND', 'citation': "Dumont LJ, Cancelas JA, Dumont DF, Siegel AH, Szczepiorkowski ZM, Rugg N, Pratt PG, Worsham DN, Hartman EL, Dunn SK, O'Leary M, Ransom JH, Michael RA, Macdonald VW. A randomized controlled trial evaluating recovery and survival of 6% dimethyl sulfoxide-frozen autologous platelets in healthy volunteers. Transfusion. 2013 Jan;53(1):128-37. doi: 10.1111/j.1537-2995.2012.03735.x. Epub 2012 Jun 7."}, {'pmid': '23003345', 'type': 'BACKGROUND', 'citation': 'Meyer E, Delaney M, Lin Y, Morris A, Pavenski K, Tinmouth A, Murphy M, Slichter SJ, Heddle N, Dumont LJ. A reporting guideline for clinical platelet transfusion studies from the BEST Collaborative. Transfusion. 2013 Jun;53(6):1328-34. doi: 10.1111/j.1537-2995.2012.03906.x. Epub 2012 Sep 25.'}, {'pmid': '21214584', 'type': 'BACKGROUND', 'citation': 'Dumont LJ, Dumont DF, Unger ZM, Siegel A, Szczepiorkowski ZM, Corson JS, Jones MK, Christoffel T, Pellham E, Bailey SL, Slichter SJ; BEST Collaborative. A randomized controlled trial comparing autologous radiolabeled in vivo platelet (PLT) recoveries and survivals of 7-day-stored PLT-rich plasma and buffy coat PLTs from the same subjects. Transfusion. 2011 Jun;51(6):1241-8. doi: 10.1111/j.1537-2995.2010.03007.x. Epub 2011 Jan 7.'}, {'pmid': '31753773', 'type': 'DERIVED', 'citation': 'Napolitano M, Mancuso S, Raso S, LoCoco L, Arfo PS, De Francisci G, Dieli F, Caccamo N, Reina A, Dolce A, Agliastro R, Siragusa S. Buffy coat-derived platelets cryopreserved using a new method: Results from a pivotal clinical trial on thrombocytopenic patients with acute leukaemia. Transfus Apher Sci. 2019 Dec;58(6):102666. doi: 10.1016/j.transci.2019.10.008. Epub 2019 Nov 5.'}]}, 'descriptionModule': {'briefSummary': 'The increasing need for blood components and the increasingly careful donor selection procedures, make the availability of blood components very reduced, in particular for platelets that are currently administered preferably "fresh" or cryopreserved, only in emergency conditions.\n\nExceeding this limit through the spread of use of cryopreserved platelets in the common clinical practice, might help clinicians to avoid wasting valuable products and face periods of particular shortage of donors Some studies already published in the literature over the last decade (1,2) have demonstrated the safety and efficacy of autologous cryopreserved platelets .\n\nThe main objective of the proposed study is to evaluate the efficacy and safety of platelets, cryopreserved with DMSO using a a new method, in patients with severe thrombocytopenia.\n\nThis is the in vivo phase of a study where availability and efficacy of cryopreserved platelets has been assessed in vitro.', 'detailedDescription': 'The primary objective of the study is to evaluate the hemostatic efficacy and safety in the recipients of platelets obtained from buffy coat of multiple donors (five), cryopreserved with DMSO using a new patented method, up to 9 months from the collection.\n\nFurther goals are the registration of any related- adverse event (idiosyncrasy, allergy, toxicity)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCryopreserved buffy coat pooled platelets will be infused, after being thawed, in inpatients at U.O. of Hematology -Policlinic "P. Giaccone"-Palermo, falling into one of the following categories:\n\n* Stable clinical conditions and no complications with platelets ≤ 10,000/microliter;\n* With active bleeding and ≤ 20,000 platelets/microliter;\n* In the presence of: high blood pressure, high fever, rapid drop in platelets, infection, chemotherapy, coagulation abnormalities with ≤ 20,000 platelets/microliter.\n\nExclusion Criteria:\n\nPatients\n\n* Suffering from congenital immunodeficiency\n* Allogeneic bone marrow transplant candidates\n* Bone Marrow Donors for transplantation\n* Undergoing bone marrow transplant or\n* Suffering from Hodgkin\'s disease and treated with purine analogues (Fludarabine, cladribine)'}, 'identificationModule': {'nctId': 'NCT02032134', 'acronym': 'MICE', 'briefTitle': 'Protocol for the Infusion of Buffy Coat-derived Cryopreserved Platelets in Patients With Severe Thrombocytopenia', 'organization': {'class': 'OTHER', 'fullName': 'University of Palermo'}, 'officialTitle': 'Experimental Protocol for the Infusion of Platelets,Cryopreserved With Dimethyl Sulphoxide (DMSO) and Obtained From Multiple Donors Buffy Coats, in Patients With Severe Thrombocytopenia', 'orgStudyIdInfo': {'id': 'CUP: G33F1100003000'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patients with severe thrombocytopenia', 'description': 'Intervention Patients with severe thrombocytopenia with an active bleeding, in preparation for surgery, or after chemotherapy (prophylaxis of bleeding),will receive transfusion of Pooled Platelets Cryopreserved In DMSO With a New System', 'interventionNames': ['Biological: Transfusion of Pooled Platelets Cryopreserved In DMSO']}], 'interventions': [{'name': 'Transfusion of Pooled Platelets Cryopreserved In DMSO', 'type': 'BIOLOGICAL', 'otherNames': ['New Cryopreservation kit (Promedical ®)', 'Buffy Coat Pooled Platelets Cryopreserved In DMSO'], 'description': 'Patients with severe thrombocytopenia will be admitted as in patients at the Hematology Unit of the Policlinic "P. Giaccone"- Palermo, if they require platelet transfusion (for bleeding, in preparation for surgery, after chemotherapy); they will receive buffy coat derived cryopreserved platelets,after thawing', 'armGroupLabels': ['Patients with severe thrombocytopenia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90127', 'city': 'Palermo', 'state': 'Regione Sicilia', 'country': 'Italy', 'facility': 'AOUP "P.Giaccone"-Hematology Unit', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}], 'overallOfficials': [{'name': 'Sergio Siragusa, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hematology Unit- University of Palermo'}, {'name': 'Mariasanta Napolitano, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hematology Unit- University of Palermo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Napolitano Mariasanta', 'class': 'OTHER'}, 'collaborators': [{'name': 'Regione Sicilia', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor (ricercatore td)', 'investigatorFullName': 'Napolitano Mariasanta', 'investigatorAffiliation': 'University of Palermo'}}}}