Therapeutic efficacy and safety of platelets treated with a photochemical process for pathogen inactivation: the SPRINT Trial
We report a transfusion trial of platelets photochemically treated for pathogen inactivation using the synthetic psoralen amotosalen HCl. Patients with thrombocytopenia were randomly assigned to receive either photochemically treated (PCT) or conventional (control) platelets for up to 28 days. The p...
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| Veröffentlicht in: | Blood 2004-09, Vol.104 (5), p.1534-1541 |
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| creator | McCullough, Jeffrey Vesole, David H. Benjamin, Richard J. Slichter, Sherrill J. Pineda, Alvaro Snyder, Edward Stadtmauer, Edward A. Lopez-Plaza, Ileana Coutre, Steven Strauss, Ronald G. Goodnough, Lawrence T. Fridey, Joy L. Raife, Thomas Cable, Ritchard Murphy, Scott Howard, Frank Davis, Kathryn Lin, Jin-Sying Metzel, Peyton Corash, Laurence Koutsoukos, Antonis Lin, Lily Buchholz, Donald H. Conlan, Maureen G. |
| description | We report a transfusion trial of platelets photochemically treated for pathogen inactivation using the synthetic psoralen amotosalen HCl. Patients with thrombocytopenia were randomly assigned to receive either photochemically treated (PCT) or conventional (control) platelets for up to 28 days. The primary end point was the proportion of patients with World Health Organization (WHO) grade 2 bleeding during the period of platelet support. A total of 645 patients (318 PCT and 327 control) were evaluated. The primary end point, the incidence of grade 2 bleeding (58.5% PCT versus 57.5% control), and the secondary end point, the incidence of grade 3 or 4 bleeding (4.1% PCT versus 6.1% control), were equivalent between the 2 groups (P= .001 by noninferiority). The mean 1-hour posttransfusion platelet corrected count increment (CCI) (11.1 × 103PCT versus 16.0 × 103control), average number of days to next platelet transfusion (1.9 PCT versus 2.4 control), and number of platelet transfusions (8.4 PCT versus 6.2 control) were different (P< .001). Transfusion reactions were fewer following PCT platelets (3.0% PCT versus 4.4% control;P= .02). The incidence of grade 2 bleeding was equivalent for PCT and conventional platelets, although posttransfusion platelet count increments and days to next transfusion were decreased for PCT compared with conventional platelets. |
| doi_str_mv | 10.1182/blood-2003-12-4443 |
| format | Article |
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Patients with thrombocytopenia were randomly assigned to receive either photochemically treated (PCT) or conventional (control) platelets for up to 28 days. The primary end point was the proportion of patients with World Health Organization (WHO) grade 2 bleeding during the period of platelet support. A total of 645 patients (318 PCT and 327 control) were evaluated. The primary end point, the incidence of grade 2 bleeding (58.5% PCT versus 57.5% control), and the secondary end point, the incidence of grade 3 or 4 bleeding (4.1% PCT versus 6.1% control), were equivalent between the 2 groups (P= .001 by noninferiority). The mean 1-hour posttransfusion platelet corrected count increment (CCI) (11.1 × 103PCT versus 16.0 × 103control), average number of days to next platelet transfusion (1.9 PCT versus 2.4 control), and number of platelet transfusions (8.4 PCT versus 6.2 control) were different (P< .001). Transfusion reactions were fewer following PCT platelets (3.0% PCT versus 4.4% control;P= .02). The incidence of grade 2 bleeding was equivalent for PCT and conventional platelets, although posttransfusion platelet count increments and days to next transfusion were decreased for PCT compared with conventional platelets.</description><identifier>ISSN: 0006-4971</identifier><identifier>EISSN: 1528-0020</identifier><identifier>DOI: 10.1182/blood-2003-12-4443</identifier><identifier>PMID: 15138160</identifier><language>eng</language><publisher>Washington, DC: Elsevier Inc</publisher><subject>Adolescent ; Adult ; Aged ; Aged, 80 and over ; Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy ; Biological and medical sciences ; Blood Platelets - drug effects ; Blood-Borne Pathogens ; Blood. Blood and plasma substitutes. Blood products. Blood cells. Blood typing. Plasmapheresis. Apheresis ; Child ; Erythrocyte Transfusion ; Female ; Furocoumarins - pharmacology ; Hemorrhage - prevention & control ; Humans ; Male ; Medical sciences ; Middle Aged ; Photochemistry ; Platelet Transfusion - adverse effects ; Prospective Studies ; Thrombocytopenia - therapy ; Transfusions. Complications. Transfusion reactions. Cell and gene therapy</subject><ispartof>Blood, 2004-09, Vol.104 (5), p.1534-1541</ispartof><rights>2004 American Society of Hematology</rights><rights>2004 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c426t-c2baa2eb3d07d912677c4f232b39d7b85b8b4c0ad6babd2a18454490c88b07323</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=16146800$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/15138160$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>McCullough, Jeffrey</creatorcontrib><creatorcontrib>Vesole, David H.</creatorcontrib><creatorcontrib>Benjamin, Richard J.</creatorcontrib><creatorcontrib>Slichter, Sherrill J.</creatorcontrib><creatorcontrib>Pineda, Alvaro</creatorcontrib><creatorcontrib>Snyder, Edward</creatorcontrib><creatorcontrib>Stadtmauer, Edward A.</creatorcontrib><creatorcontrib>Lopez-Plaza, Ileana</creatorcontrib><creatorcontrib>Coutre, Steven</creatorcontrib><creatorcontrib>Strauss, Ronald G.</creatorcontrib><creatorcontrib>Goodnough, Lawrence T.</creatorcontrib><creatorcontrib>Fridey, Joy L.</creatorcontrib><creatorcontrib>Raife, Thomas</creatorcontrib><creatorcontrib>Cable, Ritchard</creatorcontrib><creatorcontrib>Murphy, Scott</creatorcontrib><creatorcontrib>Howard, Frank</creatorcontrib><creatorcontrib>Davis, Kathryn</creatorcontrib><creatorcontrib>Lin, Jin-Sying</creatorcontrib><creatorcontrib>Metzel, Peyton</creatorcontrib><creatorcontrib>Corash, Laurence</creatorcontrib><creatorcontrib>Koutsoukos, Antonis</creatorcontrib><creatorcontrib>Lin, Lily</creatorcontrib><creatorcontrib>Buchholz, Donald H.</creatorcontrib><creatorcontrib>Conlan, Maureen G.</creatorcontrib><title>Therapeutic efficacy and safety of platelets treated with a photochemical process for pathogen inactivation: the SPRINT Trial</title><title>Blood</title><addtitle>Blood</addtitle><description>We report a transfusion trial of platelets photochemically treated for pathogen inactivation using the synthetic psoralen amotosalen HCl. Patients with thrombocytopenia were randomly assigned to receive either photochemically treated (PCT) or conventional (control) platelets for up to 28 days. The primary end point was the proportion of patients with World Health Organization (WHO) grade 2 bleeding during the period of platelet support. A total of 645 patients (318 PCT and 327 control) were evaluated. The primary end point, the incidence of grade 2 bleeding (58.5% PCT versus 57.5% control), and the secondary end point, the incidence of grade 3 or 4 bleeding (4.1% PCT versus 6.1% control), were equivalent between the 2 groups (P= .001 by noninferiority). The mean 1-hour posttransfusion platelet corrected count increment (CCI) (11.1 × 103PCT versus 16.0 × 103control), average number of days to next platelet transfusion (1.9 PCT versus 2.4 control), and number of platelet transfusions (8.4 PCT versus 6.2 control) were different (P< .001). Transfusion reactions were fewer following PCT platelets (3.0% PCT versus 4.4% control;P= .02). The incidence of grade 2 bleeding was equivalent for PCT and conventional platelets, although posttransfusion platelet count increments and days to next transfusion were decreased for PCT compared with conventional platelets.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy</subject><subject>Biological and medical sciences</subject><subject>Blood Platelets - drug effects</subject><subject>Blood-Borne Pathogens</subject><subject>Blood. Blood and plasma substitutes. Blood products. Blood cells. Blood typing. Plasmapheresis. Apheresis</subject><subject>Child</subject><subject>Erythrocyte Transfusion</subject><subject>Female</subject><subject>Furocoumarins - pharmacology</subject><subject>Hemorrhage - prevention & control</subject><subject>Humans</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Photochemistry</subject><subject>Platelet Transfusion - adverse effects</subject><subject>Prospective Studies</subject><subject>Thrombocytopenia - therapy</subject><subject>Transfusions. Complications. Transfusion reactions. Cell and gene therapy</subject><issn>0006-4971</issn><issn>1528-0020</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2004</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kD2P1DAURS0EYoeFP0CB3EAXsB3HcRANWvGx0goQDLX1bD8To0wcbM-iKfjvZJiRtqN6rzj36uoQ8pSzl5xr8cpOKflGMNY2XDRSyvYe2fBO6IYxwe6TDWNMNXLo-QV5VMpPxrhsRfeQXPCOt5ortiF_tiNmWHBfo6MYQnTgDhRmTwsErAeaAl0mqDhhLbRmXF9Pf8c6UqDLmGpyI-7W1ESXnByWQkPKdIE6ph840ziDq_EWakzza1pHpN--fL3-tKXbHGF6TB4EmAo-Od9L8v39u-3Vx-bm84frq7c3jZNC1cYJCyDQtp71fuBC9b2TQbTCtoPvre6sttIx8MqC9QK4lp2UA3NaW9a3or0kL06968ZfeyzV7GJxOE0wY9oXo1Q_9GtoBcUJdDmVkjGYJccd5IPhzBylm3_SzVG64cIcpa-hZ-f2vd2hv4ucLa_A8zMAZTUVMswuljtOcak0O3JvThyuLm4jZlNcxNmhjxldNT7F_-34C23RoVE</recordid><startdate>20040901</startdate><enddate>20040901</enddate><creator>McCullough, Jeffrey</creator><creator>Vesole, David H.</creator><creator>Benjamin, Richard J.</creator><creator>Slichter, Sherrill J.</creator><creator>Pineda, Alvaro</creator><creator>Snyder, Edward</creator><creator>Stadtmauer, Edward A.</creator><creator>Lopez-Plaza, Ileana</creator><creator>Coutre, Steven</creator><creator>Strauss, Ronald G.</creator><creator>Goodnough, Lawrence T.</creator><creator>Fridey, Joy L.</creator><creator>Raife, Thomas</creator><creator>Cable, Ritchard</creator><creator>Murphy, Scott</creator><creator>Howard, Frank</creator><creator>Davis, Kathryn</creator><creator>Lin, Jin-Sying</creator><creator>Metzel, Peyton</creator><creator>Corash, Laurence</creator><creator>Koutsoukos, Antonis</creator><creator>Lin, Lily</creator><creator>Buchholz, Donald H.</creator><creator>Conlan, Maureen G.</creator><general>Elsevier Inc</general><general>The Americain Society of Hematology</general><scope>6I.</scope><scope>AAFTH</scope><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20040901</creationdate><title>Therapeutic efficacy and safety of platelets treated with a photochemical process for pathogen inactivation: the SPRINT Trial</title><author>McCullough, Jeffrey ; Vesole, David H. ; Benjamin, Richard J. ; Slichter, Sherrill J. ; Pineda, Alvaro ; Snyder, Edward ; Stadtmauer, Edward A. ; Lopez-Plaza, Ileana ; Coutre, Steven ; Strauss, Ronald G. ; Goodnough, Lawrence T. ; Fridey, Joy L. ; Raife, Thomas ; Cable, Ritchard ; Murphy, Scott ; Howard, Frank ; Davis, Kathryn ; Lin, Jin-Sying ; Metzel, Peyton ; Corash, Laurence ; Koutsoukos, Antonis ; Lin, Lily ; Buchholz, Donald H. ; Conlan, Maureen G.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c426t-c2baa2eb3d07d912677c4f232b39d7b85b8b4c0ad6babd2a18454490c88b07323</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2004</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy</topic><topic>Biological and medical sciences</topic><topic>Blood Platelets - drug effects</topic><topic>Blood-Borne Pathogens</topic><topic>Blood. Blood and plasma substitutes. Blood products. Blood cells. Blood typing. Plasmapheresis. Apheresis</topic><topic>Child</topic><topic>Erythrocyte Transfusion</topic><topic>Female</topic><topic>Furocoumarins - pharmacology</topic><topic>Hemorrhage - prevention & control</topic><topic>Humans</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Photochemistry</topic><topic>Platelet Transfusion - adverse effects</topic><topic>Prospective Studies</topic><topic>Thrombocytopenia - therapy</topic><topic>Transfusions. Complications. Transfusion reactions. 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Patients with thrombocytopenia were randomly assigned to receive either photochemically treated (PCT) or conventional (control) platelets for up to 28 days. The primary end point was the proportion of patients with World Health Organization (WHO) grade 2 bleeding during the period of platelet support. A total of 645 patients (318 PCT and 327 control) were evaluated. The primary end point, the incidence of grade 2 bleeding (58.5% PCT versus 57.5% control), and the secondary end point, the incidence of grade 3 or 4 bleeding (4.1% PCT versus 6.1% control), were equivalent between the 2 groups (P= .001 by noninferiority). The mean 1-hour posttransfusion platelet corrected count increment (CCI) (11.1 × 103PCT versus 16.0 × 103control), average number of days to next platelet transfusion (1.9 PCT versus 2.4 control), and number of platelet transfusions (8.4 PCT versus 6.2 control) were different (P< .001). Transfusion reactions were fewer following PCT platelets (3.0% PCT versus 4.4% control;P= .02). The incidence of grade 2 bleeding was equivalent for PCT and conventional platelets, although posttransfusion platelet count increments and days to next transfusion were decreased for PCT compared with conventional platelets.</abstract><cop>Washington, DC</cop><pub>Elsevier Inc</pub><pmid>15138160</pmid><doi>10.1182/blood-2003-12-4443</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adolescent Adult Aged Aged, 80 and over Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy Biological and medical sciences Blood Platelets - drug effects Blood-Borne Pathogens Blood. Blood and plasma substitutes. Blood products. Blood cells. Blood typing. Plasmapheresis. Apheresis Child Erythrocyte Transfusion Female Furocoumarins - pharmacology Hemorrhage - prevention & control Humans Male Medical sciences Middle Aged Photochemistry Platelet Transfusion - adverse effects Prospective Studies Thrombocytopenia - therapy Transfusions. Complications. Transfusion reactions. Cell and gene therapy |
| title | Therapeutic efficacy and safety of platelets treated with a photochemical process for pathogen inactivation: the SPRINT Trial |
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