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recruitment failure within the interval of available CRY BC-PLTs for the study
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| Name | Class |
|---|---|
| Regione Sicilia | UNKNOWN |
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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.
Exceeding 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 .
The 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.
This is the in vivo phase of a study where availability and efficacy of cryopreserved platelets has been assessed in vitro.
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.
Further goals are the registration of any related- adverse event (idiosyncrasy, allergy, toxicity)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with severe thrombocytopenia | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transfusion of Pooled Platelets Cryopreserved In DMSO | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of infused cryopreserved platelets (changes in platelets count will be determined at 1 hour and 24 hours post-transfusion) | 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 | 1 Hour and 24 hours post-transfusion |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of cryopreserved platelets | Any transfusion-related side effect (i.e. idiosyncrasy, allergy, toxicity) will be monitored | During transfusion and within 48 hours after transfusion |
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Inclusion Criteria:
Cryopreserved 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:
Exclusion Criteria:
Patients
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| Name | Affiliation | Role |
|---|---|---|
| Sergio Siragusa, MD | Hematology Unit- University of Palermo | Study Director |
| Mariasanta Napolitano, MD | Hematology Unit- University of Palermo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOUP "P.Giaccone"-Hematology Unit | Palermo | Regione Sicilia | 90127 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12493312 | Background | 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. | |
| 22781890 | Background | 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. |
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| 15183900 | Background | Heal JM, Blumberg N. Optimizing platelet transfusion therapy. Blood Rev. 2004 Sep;18(3):149-65. doi: 10.1016/S0268-960X(03)00057-2. |
| 1339584 | Background | 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. |
| 22671278 | Background | 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. |
| 23003345 | Background | 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. |
| 21214584 | Background | 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. |
| 31753773 | Derived | 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. |
| ID | Term |
|---|---|
| D013921 | Thrombocytopenia |
| ID | Term |
|---|---|
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
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| ID | Term |
|---|---|
| D004121 | Dimethyl Sulfoxide |
| ID | Term |
|---|---|
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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