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Bilateral lysis of aortic saddle thrombus with early tissue plasminogen activator (BLASTT): a prospective, randomized, placebo-controlled study in feline acute aortic thromboembolism
Objectives The aim of this study was to investigate the impact of tissue plasminogen activator (TPA) on the treatment of feline aortic thromboembolism (FATE). Methods Cats diagnosed with FATE involving ⩾2 limbs were enrolled in a prospective, multicenter, double-blinded, randomized, placebo-controll...
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| Published in: | Journal of feline medicine and surgery 2022-12, Vol.24 (12), p.e535-e545 |
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| container_issue | 12 |
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| container_title | Journal of feline medicine and surgery |
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| creator | Guillaumin, Julien DeFrancesco, Teresa C Scansen, Brian A Quinn, Rebecca Whelan, Megan Hanel, Rita Goy-Thollot, Isabelle Bublot, Isabelle Robertson, James B Bonagura, John D |
| description | Objectives
The aim of this study was to investigate the impact of tissue plasminogen activator (TPA) on the treatment of feline aortic thromboembolism (FATE).
Methods
Cats diagnosed with FATE involving ⩾2 limbs were enrolled in a prospective, multicenter, double-blinded, randomized, placebo-controlled study within 6 h of an event. Diagnosis was made by clinical findings and one confirmatory criterion. Cats received placebo or TPA (1 mg/kg/h with the first 10% by bolus). All cats received pain control and thromboprophylaxis. The primary outcome was a change from baseline in a published limb score at 48 h. Secondary outcomes included 48 h survival, survival to discharge and complication proportions. Statistical analyses included pattern-mixture models, logistic regression and Fisher’s exact, Student’s t- and Mann–Whitney–Wilcoxon tests.
Results
Based on a power analysis, 40 cats were enrolled; however, only 20 survived to 48 h (TPA, n = 12; placebo, n = 8 [P = 0.34]). There was a statistically significant improvement in limb scores compared with baseline for both groups (P |
| doi_str_mv | 10.1177/1098612X221135105 |
| format | article |
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The aim of this study was to investigate the impact of tissue plasminogen activator (TPA) on the treatment of feline aortic thromboembolism (FATE).
Methods
Cats diagnosed with FATE involving ⩾2 limbs were enrolled in a prospective, multicenter, double-blinded, randomized, placebo-controlled study within 6 h of an event. Diagnosis was made by clinical findings and one confirmatory criterion. Cats received placebo or TPA (1 mg/kg/h with the first 10% by bolus). All cats received pain control and thromboprophylaxis. The primary outcome was a change from baseline in a published limb score at 48 h. Secondary outcomes included 48 h survival, survival to discharge and complication proportions. Statistical analyses included pattern-mixture models, logistic regression and Fisher’s exact, Student’s t- and Mann–Whitney–Wilcoxon tests.
Results
Based on a power analysis, 40 cats were enrolled; however, only 20 survived to 48 h (TPA, n = 12; placebo, n = 8 [P = 0.34]). There was a statistically significant improvement in limb scores compared with baseline for both groups (P <0.001). Limb score at 48 h was 1 point lower (better) in the TPA group (P = 0.19). Thrombolysis had no statistically significant effect on 48 h survival (P = 0.22). Lower affected limb lactate was associated with better 48 h survival (odds ratio 1.53, 95% confidence interval 1.08–2.17; P = 0.02). The survival to discharge rates were 45% (TPA) and 30% (placebo; P = 0.51). Complications in the TPA and placebo groups included acute kidney injury (22% and 19%, respectively; P = 1.00) and/or reperfusion injuries (33% and 19%, respectively; P = 0.45).
Conclusions and relevance
Survival and complication rates of acute FATE were not different with or without thrombolysis. High in-hospital mortality decreased the statistical power to detect a statistically significant difference between treatments with regard to our primary outcome.</description><identifier>ISSN: 1098-612X</identifier><identifier>ISSN: 1532-2750</identifier><identifier>EISSN: 1532-2750</identifier><identifier>DOI: 10.1177/1098612X221135105</identifier><identifier>PMID: 36350753</identifier><language>eng</language><publisher>London, England: SAGE Publications</publisher><subject>Animals ; Anticoagulants ; Cat Diseases - drug therapy ; Cats ; Life Sciences ; Original ; Prospective Studies ; Research Design ; Tissue Plasminogen Activator - therapeutic use ; Venous Thromboembolism - veterinary</subject><ispartof>Journal of feline medicine and surgery, 2022-12, Vol.24 (12), p.e535-e545</ispartof><rights>The Author(s) 2022</rights><rights>Distributed under a Creative Commons Attribution 4.0 International License</rights><rights>The Author(s) 2022 2022 International Society of Feline Medicine and American Association of Feline Practitioners</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c430t-e204fe49a75c06246dd25892df0d686d02f893356a46e1b401c39f69a68c5ea3</citedby><cites>FETCH-LOGICAL-c430t-e204fe49a75c06246dd25892df0d686d02f893356a46e1b401c39f69a68c5ea3</cites><orcidid>0000-0001-8622-4387</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC10812363/pdf/$$EPDF$$P50$$Gpubmedcentral$$H</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC10812363/$$EHTML$$P50$$Gpubmedcentral$$H</linktohtml><link.rule.ids>230,314,727,780,784,885,21966,27853,27924,27925,44945,45333,53791,53793</link.rule.ids><linktorsrc>$$Uhttps://journals.sagepub.com/doi/full/10.1177/1098612X221135105?utm_source=summon&utm_medium=discovery-provider$$EView_record_in_SAGE_Publications$$FView_record_in_$$GSAGE_Publications</linktorsrc><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36350753$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://hal.science/hal-04493701$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Guillaumin, Julien</creatorcontrib><creatorcontrib>DeFrancesco, Teresa C</creatorcontrib><creatorcontrib>Scansen, Brian A</creatorcontrib><creatorcontrib>Quinn, Rebecca</creatorcontrib><creatorcontrib>Whelan, Megan</creatorcontrib><creatorcontrib>Hanel, Rita</creatorcontrib><creatorcontrib>Goy-Thollot, Isabelle</creatorcontrib><creatorcontrib>Bublot, Isabelle</creatorcontrib><creatorcontrib>Robertson, James B</creatorcontrib><creatorcontrib>Bonagura, John D</creatorcontrib><title>Bilateral lysis of aortic saddle thrombus with early tissue plasminogen activator (BLASTT): a prospective, randomized, placebo-controlled study in feline acute aortic thromboembolism</title><title>Journal of feline medicine and surgery</title><addtitle>J Feline Med Surg</addtitle><description>Objectives
The aim of this study was to investigate the impact of tissue plasminogen activator (TPA) on the treatment of feline aortic thromboembolism (FATE).
Methods
Cats diagnosed with FATE involving ⩾2 limbs were enrolled in a prospective, multicenter, double-blinded, randomized, placebo-controlled study within 6 h of an event. Diagnosis was made by clinical findings and one confirmatory criterion. Cats received placebo or TPA (1 mg/kg/h with the first 10% by bolus). All cats received pain control and thromboprophylaxis. The primary outcome was a change from baseline in a published limb score at 48 h. Secondary outcomes included 48 h survival, survival to discharge and complication proportions. Statistical analyses included pattern-mixture models, logistic regression and Fisher’s exact, Student’s t- and Mann–Whitney–Wilcoxon tests.
Results
Based on a power analysis, 40 cats were enrolled; however, only 20 survived to 48 h (TPA, n = 12; placebo, n = 8 [P = 0.34]). There was a statistically significant improvement in limb scores compared with baseline for both groups (P <0.001). Limb score at 48 h was 1 point lower (better) in the TPA group (P = 0.19). Thrombolysis had no statistically significant effect on 48 h survival (P = 0.22). Lower affected limb lactate was associated with better 48 h survival (odds ratio 1.53, 95% confidence interval 1.08–2.17; P = 0.02). The survival to discharge rates were 45% (TPA) and 30% (placebo; P = 0.51). Complications in the TPA and placebo groups included acute kidney injury (22% and 19%, respectively; P = 1.00) and/or reperfusion injuries (33% and 19%, respectively; P = 0.45).
Conclusions and relevance
Survival and complication rates of acute FATE were not different with or without thrombolysis. High in-hospital mortality decreased the statistical power to detect a statistically significant difference between treatments with regard to our primary outcome.</description><subject>Animals</subject><subject>Anticoagulants</subject><subject>Cat Diseases - drug therapy</subject><subject>Cats</subject><subject>Life Sciences</subject><subject>Original</subject><subject>Prospective Studies</subject><subject>Research Design</subject><subject>Tissue Plasminogen Activator - therapeutic use</subject><subject>Venous Thromboembolism - veterinary</subject><issn>1098-612X</issn><issn>1532-2750</issn><issn>1532-2750</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><recordid>eNp9Ustu1DAUjRCIlsIHsEFetlJT_IidhE01rWiLNBILZsHO8tg3M66ceLCdQcOH8X04SlvxkFhYtnwePj66RfGW4AtC6vo9wW0jCP1KKSGME8yfFceEM1rSmuPn-ZzxciIcFa9ivMcYt6ylL4sjJhjHNWfHxc8r61SCoBxyh2gj8h1SPiSrUVTGOEBpG3y_HiP6btMWgQrugJKNcQS0cyr2dvAbGJDSye5V8gGdXi0XX1arsw9IoV3wcQcTBOcoqMH43v4Acz5JNax9qf2QgncODIppNAdkB9SBswNkxzHBY5g5hYe8nI396-JFp1yENw_7SbG6-bi6viuXn28_XS-Wpa4YTiVQXHVQtarmGgtaCWMob1pqOmxEIwymXdMyxoWqBJB1hYlmbSdaJRrNQbGT4nK23Y3rHoyGHFY5uQu2V-EgvbLyT2SwW7nxe0lwQ2huOTuczQ7bv3R3i6Wc7nBVtazGZE8y9_ThteC_jRCT7G3U4JwawI9R0ppVgjBST1QyU3UuOAbonrwJltNsyH9mI2ve_f6ZJ8XjMGTCxUyIagPy3o9hyN3-x_EX7yjFug</recordid><startdate>20221201</startdate><enddate>20221201</enddate><creator>Guillaumin, Julien</creator><creator>DeFrancesco, Teresa C</creator><creator>Scansen, Brian A</creator><creator>Quinn, Rebecca</creator><creator>Whelan, Megan</creator><creator>Hanel, Rita</creator><creator>Goy-Thollot, Isabelle</creator><creator>Bublot, Isabelle</creator><creator>Robertson, James B</creator><creator>Bonagura, John D</creator><general>SAGE Publications</general><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><scope>1XC</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-8622-4387</orcidid></search><sort><creationdate>20221201</creationdate><title>Bilateral lysis of aortic saddle thrombus with early tissue plasminogen activator (BLASTT): a prospective, randomized, placebo-controlled study in feline acute aortic thromboembolism</title><author>Guillaumin, Julien ; DeFrancesco, Teresa C ; Scansen, Brian A ; Quinn, Rebecca ; Whelan, Megan ; Hanel, Rita ; Goy-Thollot, Isabelle ; Bublot, Isabelle ; Robertson, James B ; Bonagura, John D</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c430t-e204fe49a75c06246dd25892df0d686d02f893356a46e1b401c39f69a68c5ea3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Animals</topic><topic>Anticoagulants</topic><topic>Cat Diseases - drug therapy</topic><topic>Cats</topic><topic>Life Sciences</topic><topic>Original</topic><topic>Prospective Studies</topic><topic>Research Design</topic><topic>Tissue Plasminogen Activator - therapeutic use</topic><topic>Venous Thromboembolism - veterinary</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Guillaumin, Julien</creatorcontrib><creatorcontrib>DeFrancesco, Teresa C</creatorcontrib><creatorcontrib>Scansen, Brian A</creatorcontrib><creatorcontrib>Quinn, Rebecca</creatorcontrib><creatorcontrib>Whelan, Megan</creatorcontrib><creatorcontrib>Hanel, Rita</creatorcontrib><creatorcontrib>Goy-Thollot, Isabelle</creatorcontrib><creatorcontrib>Bublot, Isabelle</creatorcontrib><creatorcontrib>Robertson, James B</creatorcontrib><creatorcontrib>Bonagura, John D</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>Hyper Article en Ligne (HAL)</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Journal of feline medicine and surgery</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext_linktorsrc</fulltext></delivery><addata><au>Guillaumin, Julien</au><au>DeFrancesco, Teresa C</au><au>Scansen, Brian A</au><au>Quinn, Rebecca</au><au>Whelan, Megan</au><au>Hanel, Rita</au><au>Goy-Thollot, Isabelle</au><au>Bublot, Isabelle</au><au>Robertson, James B</au><au>Bonagura, John D</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Bilateral lysis of aortic saddle thrombus with early tissue plasminogen activator (BLASTT): a prospective, randomized, placebo-controlled study in feline acute aortic thromboembolism</atitle><jtitle>Journal of feline medicine and surgery</jtitle><addtitle>J Feline Med Surg</addtitle><date>2022-12-01</date><risdate>2022</risdate><volume>24</volume><issue>12</issue><spage>e535</spage><epage>e545</epage><pages>e535-e545</pages><issn>1098-612X</issn><issn>1532-2750</issn><eissn>1532-2750</eissn><abstract>Objectives
The aim of this study was to investigate the impact of tissue plasminogen activator (TPA) on the treatment of feline aortic thromboembolism (FATE).
Methods
Cats diagnosed with FATE involving ⩾2 limbs were enrolled in a prospective, multicenter, double-blinded, randomized, placebo-controlled study within 6 h of an event. Diagnosis was made by clinical findings and one confirmatory criterion. Cats received placebo or TPA (1 mg/kg/h with the first 10% by bolus). All cats received pain control and thromboprophylaxis. The primary outcome was a change from baseline in a published limb score at 48 h. Secondary outcomes included 48 h survival, survival to discharge and complication proportions. Statistical analyses included pattern-mixture models, logistic regression and Fisher’s exact, Student’s t- and Mann–Whitney–Wilcoxon tests.
Results
Based on a power analysis, 40 cats were enrolled; however, only 20 survived to 48 h (TPA, n = 12; placebo, n = 8 [P = 0.34]). There was a statistically significant improvement in limb scores compared with baseline for both groups (P <0.001). Limb score at 48 h was 1 point lower (better) in the TPA group (P = 0.19). Thrombolysis had no statistically significant effect on 48 h survival (P = 0.22). Lower affected limb lactate was associated with better 48 h survival (odds ratio 1.53, 95% confidence interval 1.08–2.17; P = 0.02). The survival to discharge rates were 45% (TPA) and 30% (placebo; P = 0.51). Complications in the TPA and placebo groups included acute kidney injury (22% and 19%, respectively; P = 1.00) and/or reperfusion injuries (33% and 19%, respectively; P = 0.45).
Conclusions and relevance
Survival and complication rates of acute FATE were not different with or without thrombolysis. High in-hospital mortality decreased the statistical power to detect a statistically significant difference between treatments with regard to our primary outcome.</abstract><cop>London, England</cop><pub>SAGE Publications</pub><pmid>36350753</pmid><doi>10.1177/1098612X221135105</doi><orcidid>https://orcid.org/0000-0001-8622-4387</orcidid><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 1098-612X |
| ispartof | Journal of feline medicine and surgery, 2022-12, Vol.24 (12), p.e535-e545 |
| issn | 1098-612X 1532-2750 1532-2750 |
| language | eng |
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| source | SAGE Open Access |
| subjects | Animals Anticoagulants Cat Diseases - drug therapy Cats Life Sciences Original Prospective Studies Research Design Tissue Plasminogen Activator - therapeutic use Venous Thromboembolism - veterinary |
| title | Bilateral lysis of aortic saddle thrombus with early tissue plasminogen activator (BLASTT): a prospective, randomized, placebo-controlled study in feline acute aortic thromboembolism |
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