Cost-effectiveness of Fibrinogen Concentrate vs Cryoprecipitate for Treating Acquired Hypofibrinogenemia in Bleeding Adult Cardiac Surgical Patients
IMPORTANCE: Excessive bleeding requiring fibrinogen replacement is a serious complication of cardiac surgery. However, the relative cost-effectiveness of the 2 available therapies—fibrinogen concentrate and cryoprecipitate—is unknown. OBJECTIVE: To determine cost-effectiveness of fibrinogen concentr...
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Veröffentlicht in: | Archives of surgery (Chicago. 1960) 2023-03, Vol.158 (3), p.245-253 |
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creator | Abrahamyan, Lusine Tomlinson, George Callum, Jeannie Carcone, Steven Grewal, Deep Bartoszko, Justyna Krahn, Murray Karkouti, Keyvan |
description | IMPORTANCE: Excessive bleeding requiring fibrinogen replacement is a serious complication of cardiac surgery. However, the relative cost-effectiveness of the 2 available therapies—fibrinogen concentrate and cryoprecipitate—is unknown. OBJECTIVE: To determine cost-effectiveness of fibrinogen concentrate vs cryoprecipitate for managing active bleeding in adult patients who underwent cardiac surgery. DESIGN, SETTING, AND PARTICIPANTS: A within-trial economic evaluation of the Fibrinogen Replenishment in Surgery (FIBERS) randomized clinical trial (February 2017 to November 2018) that took place at 4 hospitals based in Ontario, Canada, hospitals examined all in-hospital resource utilization costs and allogeneic blood product (ABP) transfusion costs incurred within 28 days of surgery. Participants included a subset of 495 adult patients from the FIBERS trial who underwent cardiac surgery and developed active bleeding and acquired hypofibrinogenemia requiring fibrinogen replacement. INTERVENTIONS: Fibrinogen concentrate (4 g per dose) or cryoprecipitate (10 units per dose) randomized (1:1) up to 24 hours postcardiopulmonary bypass. MAIN OUTCOMES AND MEASURES: Effectiveness outcomes included number of ABPs administered within 24 hours and 7 days of cardiopulmonary bypass. ABP transfusion (7-day) and in-hospital resource utilization (28-day) costs were evaluated and a multivariable net benefit regression model built for the full sample and predefined subgroups. RESULTS: Patient level costs for 495 patients were evaluated (mean [SD] age 59.2 [15.4] years and 69.3% male.) Consistent with FIBERS, ABP transfusions and adverse events were similar in both treatment groups. Median (IQR) total 7-day ABP cost was CAD $2280 (US dollars [USD] $1697) (CAD $930 [USD $692]-CAD $4970 [USD $3701]) in the fibrinogen concentrate group and CAD $2770 (USD $1690) (IQR, CAD $1140 [USD $849]-CAD $5000 [USD $3723]) in the cryoprecipitate group. Median (interquartile range) total 28-day cost was CAD $38 180 (USD $28 431) $(IQR, CAD $26 350 [USD $19 622]-CAD $65 080 [USD $48 463]) in the fibrinogen concentrate group and CAD $38 790 (USD $28 886) (IQR, CAD $26 180 [USD $19 495]-CAD $70 380 [USD $52 409]) in the cryoprecipitate group. After exclusion of patients who were critically ill before surgery (11%) due to substantial variability in costs, the incremental net benefit of fibrinogen concentrate vs cryoprecipitate was positive (probability of being cost-effective 86% and 97% at $0 and CAD |
doi_str_mv | 10.1001/jamasurg.2022.6818 |
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However, the relative cost-effectiveness of the 2 available therapies—fibrinogen concentrate and cryoprecipitate—is unknown. OBJECTIVE: To determine cost-effectiveness of fibrinogen concentrate vs cryoprecipitate for managing active bleeding in adult patients who underwent cardiac surgery. DESIGN, SETTING, AND PARTICIPANTS: A within-trial economic evaluation of the Fibrinogen Replenishment in Surgery (FIBERS) randomized clinical trial (February 2017 to November 2018) that took place at 4 hospitals based in Ontario, Canada, hospitals examined all in-hospital resource utilization costs and allogeneic blood product (ABP) transfusion costs incurred within 28 days of surgery. Participants included a subset of 495 adult patients from the FIBERS trial who underwent cardiac surgery and developed active bleeding and acquired hypofibrinogenemia requiring fibrinogen replacement. INTERVENTIONS: Fibrinogen concentrate (4 g per dose) or cryoprecipitate (10 units per dose) randomized (1:1) up to 24 hours postcardiopulmonary bypass. MAIN OUTCOMES AND MEASURES: Effectiveness outcomes included number of ABPs administered within 24 hours and 7 days of cardiopulmonary bypass. ABP transfusion (7-day) and in-hospital resource utilization (28-day) costs were evaluated and a multivariable net benefit regression model built for the full sample and predefined subgroups. RESULTS: Patient level costs for 495 patients were evaluated (mean [SD] age 59.2 [15.4] years and 69.3% male.) Consistent with FIBERS, ABP transfusions and adverse events were similar in both treatment groups. Median (IQR) total 7-day ABP cost was CAD $2280 (US dollars [USD] $1697) (CAD $930 [USD $692]-CAD $4970 [USD $3701]) in the fibrinogen concentrate group and CAD $2770 (USD $1690) (IQR, CAD $1140 [USD $849]-CAD $5000 [USD $3723]) in the cryoprecipitate group. Median (interquartile range) total 28-day cost was CAD $38 180 (USD $28 431) $(IQR, CAD $26 350 [USD $19 622]-CAD $65 080 [USD $48 463]) in the fibrinogen concentrate group and CAD $38 790 (USD $28 886) (IQR, CAD $26 180 [USD $19 495]-CAD $70 380 [USD $52 409]) in the cryoprecipitate group. After exclusion of patients who were critically ill before surgery (11%) due to substantial variability in costs, the incremental net benefit of fibrinogen concentrate vs cryoprecipitate was positive (probability of being cost-effective 86% and 97% at $0 and CAD $2000 (USD $1489) willingness-to-pay, respectively). Net benefit was highly uncertain for nonelective and patients with critical illness. CONCLUSIONS AND RELEVANCE: Fibrinogen concentrate is cost-effective when compared with cryoprecipitate in most bleeding adult patients who underwent cardiac surgery with acquired hypofibrinogenemia requiring fibrinogen replacement. The generalizability of these findings outside the Canadian health system needs to be verified.</description><identifier>ISSN: 2168-6254</identifier><identifier>EISSN: 2168-6262</identifier><identifier>DOI: 10.1001/jamasurg.2022.6818</identifier><identifier>PMID: 36598773</identifier><language>eng</language><publisher>United States: American Medical Association</publisher><subject>Adult ; Afibrinogenemia - chemically induced ; Afibrinogenemia - drug therapy ; Cardiac Surgical Procedures - adverse effects ; Cardiovascular disease ; Clinical trials ; Cost-Benefit Analysis ; Female ; Fibrinogen - therapeutic use ; Heart surgery ; Hemorrhage ; Hemorrhage - etiology ; Hemostatics - therapeutic use ; Humans ; Male ; Middle Aged ; Online First ; Ontario ; Original Investigation ; Risk factors ; Surgical outcomes</subject><ispartof>Archives of surgery (Chicago. 1960), 2023-03, Vol.158 (3), p.245-253</ispartof><rights>Copyright American Medical Association Mar 2023</rights><rights>Copyright 2023 Abrahamyan L et al. .</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-a449t-2812da1884113070a8d489fce183981a60dd7dd94524c806eaf46cc4a5e85da43</citedby><cites>FETCH-LOGICAL-a449t-2812da1884113070a8d489fce183981a60dd7dd94524c806eaf46cc4a5e85da43</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://jamanetwork.com/journals/jamasurgery/articlepdf/10.1001/jamasurg.2022.6818$$EPDF$$P50$$Gama$$H</linktopdf><linktohtml>$$Uhttps://jamanetwork.com/journals/jamasurgery/fullarticle/10.1001/jamasurg.2022.6818$$EHTML$$P50$$Gama$$H</linktohtml><link.rule.ids>64,230,314,776,780,881,3327,27901,27902,76232,76235</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36598773$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Abrahamyan, Lusine</creatorcontrib><creatorcontrib>Tomlinson, George</creatorcontrib><creatorcontrib>Callum, Jeannie</creatorcontrib><creatorcontrib>Carcone, Steven</creatorcontrib><creatorcontrib>Grewal, Deep</creatorcontrib><creatorcontrib>Bartoszko, Justyna</creatorcontrib><creatorcontrib>Krahn, Murray</creatorcontrib><creatorcontrib>Karkouti, Keyvan</creatorcontrib><title>Cost-effectiveness of Fibrinogen Concentrate vs Cryoprecipitate for Treating Acquired Hypofibrinogenemia in Bleeding Adult Cardiac Surgical Patients</title><title>Archives of surgery (Chicago. 1960)</title><addtitle>JAMA Surg</addtitle><description>IMPORTANCE: Excessive bleeding requiring fibrinogen replacement is a serious complication of cardiac surgery. However, the relative cost-effectiveness of the 2 available therapies—fibrinogen concentrate and cryoprecipitate—is unknown. OBJECTIVE: To determine cost-effectiveness of fibrinogen concentrate vs cryoprecipitate for managing active bleeding in adult patients who underwent cardiac surgery. DESIGN, SETTING, AND PARTICIPANTS: A within-trial economic evaluation of the Fibrinogen Replenishment in Surgery (FIBERS) randomized clinical trial (February 2017 to November 2018) that took place at 4 hospitals based in Ontario, Canada, hospitals examined all in-hospital resource utilization costs and allogeneic blood product (ABP) transfusion costs incurred within 28 days of surgery. Participants included a subset of 495 adult patients from the FIBERS trial who underwent cardiac surgery and developed active bleeding and acquired hypofibrinogenemia requiring fibrinogen replacement. INTERVENTIONS: Fibrinogen concentrate (4 g per dose) or cryoprecipitate (10 units per dose) randomized (1:1) up to 24 hours postcardiopulmonary bypass. MAIN OUTCOMES AND MEASURES: Effectiveness outcomes included number of ABPs administered within 24 hours and 7 days of cardiopulmonary bypass. ABP transfusion (7-day) and in-hospital resource utilization (28-day) costs were evaluated and a multivariable net benefit regression model built for the full sample and predefined subgroups. RESULTS: Patient level costs for 495 patients were evaluated (mean [SD] age 59.2 [15.4] years and 69.3% male.) Consistent with FIBERS, ABP transfusions and adverse events were similar in both treatment groups. Median (IQR) total 7-day ABP cost was CAD $2280 (US dollars [USD] $1697) (CAD $930 [USD $692]-CAD $4970 [USD $3701]) in the fibrinogen concentrate group and CAD $2770 (USD $1690) (IQR, CAD $1140 [USD $849]-CAD $5000 [USD $3723]) in the cryoprecipitate group. Median (interquartile range) total 28-day cost was CAD $38 180 (USD $28 431) $(IQR, CAD $26 350 [USD $19 622]-CAD $65 080 [USD $48 463]) in the fibrinogen concentrate group and CAD $38 790 (USD $28 886) (IQR, CAD $26 180 [USD $19 495]-CAD $70 380 [USD $52 409]) in the cryoprecipitate group. After exclusion of patients who were critically ill before surgery (11%) due to substantial variability in costs, the incremental net benefit of fibrinogen concentrate vs cryoprecipitate was positive (probability of being cost-effective 86% and 97% at $0 and CAD $2000 (USD $1489) willingness-to-pay, respectively). Net benefit was highly uncertain for nonelective and patients with critical illness. CONCLUSIONS AND RELEVANCE: Fibrinogen concentrate is cost-effective when compared with cryoprecipitate in most bleeding adult patients who underwent cardiac surgery with acquired hypofibrinogenemia requiring fibrinogen replacement. The generalizability of these findings outside the Canadian health system needs to be verified.</description><subject>Adult</subject><subject>Afibrinogenemia - chemically induced</subject><subject>Afibrinogenemia - drug therapy</subject><subject>Cardiac Surgical Procedures - adverse effects</subject><subject>Cardiovascular disease</subject><subject>Clinical trials</subject><subject>Cost-Benefit Analysis</subject><subject>Female</subject><subject>Fibrinogen - therapeutic use</subject><subject>Heart surgery</subject><subject>Hemorrhage</subject><subject>Hemorrhage - etiology</subject><subject>Hemostatics - therapeutic use</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Online First</subject><subject>Ontario</subject><subject>Original Investigation</subject><subject>Risk factors</subject><subject>Surgical outcomes</subject><issn>2168-6254</issn><issn>2168-6262</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdkd9qFDEYxQdRbKl9gV5IwBtvZpt_k0luhDpYWygoWK9DmnyzZplJpsnMwr5HH9is2y5qbhLy_c5JDqeqLgheEYzJ5caMJi9pvaKY0pWQRL6qTikRshZU0NfHc8NPqvOcN7gsiTFn6m11wkSjZNuy0-qpi3muoe_Bzn4LAXJGsUfX_iH5ENcQUBeDhTAnMwPaZtSlXZwSWD_5eX_Vx4TuE5jZhzW6so-LT-DQzW6K_dEDRm-QD-jzAOD-cG4ZZtSZ5Lyx6EeJ4a0Z0PfiUp7K76o3vRkynD_vZ9XP6y_33U199-3rbXd1VxvO1VxTSagzREpOCMMtNtJxqXoLRDIliRHYudY5xRvKrcQCTM-Ftdw0IBtnODurPh18p-VhBHeIOegp-dGknY7G638nwf_S67jVSjatxE0x-PhskOLjAnnWo88WhsEEiEvWtBW4NNMyXNAP_6GbuKRQ4hVKCsVaQlmh6IGyKeacoD9-hmC9712_9K73vet970X0_u8YR8lLywW4OABFe5zSVinJBPsNDda3KQ</recordid><startdate>20230301</startdate><enddate>20230301</enddate><creator>Abrahamyan, Lusine</creator><creator>Tomlinson, George</creator><creator>Callum, Jeannie</creator><creator>Carcone, Steven</creator><creator>Grewal, Deep</creator><creator>Bartoszko, Justyna</creator><creator>Krahn, Murray</creator><creator>Karkouti, Keyvan</creator><general>American Medical Association</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>K9.</scope><scope>NAPCQ</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20230301</creationdate><title>Cost-effectiveness of Fibrinogen Concentrate vs Cryoprecipitate for Treating Acquired Hypofibrinogenemia in Bleeding Adult Cardiac Surgical Patients</title><author>Abrahamyan, Lusine ; Tomlinson, George ; Callum, Jeannie ; Carcone, Steven ; Grewal, Deep ; Bartoszko, Justyna ; Krahn, Murray ; Karkouti, Keyvan</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-a449t-2812da1884113070a8d489fce183981a60dd7dd94524c806eaf46cc4a5e85da43</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Adult</topic><topic>Afibrinogenemia - chemically induced</topic><topic>Afibrinogenemia - drug therapy</topic><topic>Cardiac Surgical Procedures - adverse effects</topic><topic>Cardiovascular disease</topic><topic>Clinical trials</topic><topic>Cost-Benefit Analysis</topic><topic>Female</topic><topic>Fibrinogen - therapeutic use</topic><topic>Heart surgery</topic><topic>Hemorrhage</topic><topic>Hemorrhage - etiology</topic><topic>Hemostatics - therapeutic use</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Online First</topic><topic>Ontario</topic><topic>Original Investigation</topic><topic>Risk factors</topic><topic>Surgical outcomes</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Abrahamyan, Lusine</creatorcontrib><creatorcontrib>Tomlinson, George</creatorcontrib><creatorcontrib>Callum, Jeannie</creatorcontrib><creatorcontrib>Carcone, Steven</creatorcontrib><creatorcontrib>Grewal, Deep</creatorcontrib><creatorcontrib>Bartoszko, Justyna</creatorcontrib><creatorcontrib>Krahn, Murray</creatorcontrib><creatorcontrib>Karkouti, Keyvan</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Archives of surgery (Chicago. 1960)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Abrahamyan, Lusine</au><au>Tomlinson, George</au><au>Callum, Jeannie</au><au>Carcone, Steven</au><au>Grewal, Deep</au><au>Bartoszko, Justyna</au><au>Krahn, Murray</au><au>Karkouti, Keyvan</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Cost-effectiveness of Fibrinogen Concentrate vs Cryoprecipitate for Treating Acquired Hypofibrinogenemia in Bleeding Adult Cardiac Surgical Patients</atitle><jtitle>Archives of surgery (Chicago. 1960)</jtitle><addtitle>JAMA Surg</addtitle><date>2023-03-01</date><risdate>2023</risdate><volume>158</volume><issue>3</issue><spage>245</spage><epage>253</epage><pages>245-253</pages><issn>2168-6254</issn><eissn>2168-6262</eissn><abstract>IMPORTANCE: Excessive bleeding requiring fibrinogen replacement is a serious complication of cardiac surgery. However, the relative cost-effectiveness of the 2 available therapies—fibrinogen concentrate and cryoprecipitate—is unknown. OBJECTIVE: To determine cost-effectiveness of fibrinogen concentrate vs cryoprecipitate for managing active bleeding in adult patients who underwent cardiac surgery. DESIGN, SETTING, AND PARTICIPANTS: A within-trial economic evaluation of the Fibrinogen Replenishment in Surgery (FIBERS) randomized clinical trial (February 2017 to November 2018) that took place at 4 hospitals based in Ontario, Canada, hospitals examined all in-hospital resource utilization costs and allogeneic blood product (ABP) transfusion costs incurred within 28 days of surgery. Participants included a subset of 495 adult patients from the FIBERS trial who underwent cardiac surgery and developed active bleeding and acquired hypofibrinogenemia requiring fibrinogen replacement. INTERVENTIONS: Fibrinogen concentrate (4 g per dose) or cryoprecipitate (10 units per dose) randomized (1:1) up to 24 hours postcardiopulmonary bypass. MAIN OUTCOMES AND MEASURES: Effectiveness outcomes included number of ABPs administered within 24 hours and 7 days of cardiopulmonary bypass. ABP transfusion (7-day) and in-hospital resource utilization (28-day) costs were evaluated and a multivariable net benefit regression model built for the full sample and predefined subgroups. RESULTS: Patient level costs for 495 patients were evaluated (mean [SD] age 59.2 [15.4] years and 69.3% male.) Consistent with FIBERS, ABP transfusions and adverse events were similar in both treatment groups. Median (IQR) total 7-day ABP cost was CAD $2280 (US dollars [USD] $1697) (CAD $930 [USD $692]-CAD $4970 [USD $3701]) in the fibrinogen concentrate group and CAD $2770 (USD $1690) (IQR, CAD $1140 [USD $849]-CAD $5000 [USD $3723]) in the cryoprecipitate group. Median (interquartile range) total 28-day cost was CAD $38 180 (USD $28 431) $(IQR, CAD $26 350 [USD $19 622]-CAD $65 080 [USD $48 463]) in the fibrinogen concentrate group and CAD $38 790 (USD $28 886) (IQR, CAD $26 180 [USD $19 495]-CAD $70 380 [USD $52 409]) in the cryoprecipitate group. After exclusion of patients who were critically ill before surgery (11%) due to substantial variability in costs, the incremental net benefit of fibrinogen concentrate vs cryoprecipitate was positive (probability of being cost-effective 86% and 97% at $0 and CAD $2000 (USD $1489) willingness-to-pay, respectively). Net benefit was highly uncertain for nonelective and patients with critical illness. CONCLUSIONS AND RELEVANCE: Fibrinogen concentrate is cost-effective when compared with cryoprecipitate in most bleeding adult patients who underwent cardiac surgery with acquired hypofibrinogenemia requiring fibrinogen replacement. The generalizability of these findings outside the Canadian health system needs to be verified.</abstract><cop>United States</cop><pub>American Medical Association</pub><pmid>36598773</pmid><doi>10.1001/jamasurg.2022.6818</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
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subjects | Adult Afibrinogenemia - chemically induced Afibrinogenemia - drug therapy Cardiac Surgical Procedures - adverse effects Cardiovascular disease Clinical trials Cost-Benefit Analysis Female Fibrinogen - therapeutic use Heart surgery Hemorrhage Hemorrhage - etiology Hemostatics - therapeutic use Humans Male Middle Aged Online First Ontario Original Investigation Risk factors Surgical outcomes |
title | Cost-effectiveness of Fibrinogen Concentrate vs Cryoprecipitate for Treating Acquired Hypofibrinogenemia in Bleeding Adult Cardiac Surgical Patients |
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