Fibrinogen concentrate reduces intraoperative bleeding when used as first-line hemostatic therapy during major aortic replacement surgery: Results from a randomized, placebo-controlled trial
Objectives We assessed whether fibrinogen concentrate as targeted first-line hemostatic therapy was more effective than placebo or a standardized transfusion algorithm in controlling coagulopathic bleeding in patients undergoing major aortic surgery. Methods In this single-center, prospective, doubl...
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| Veröffentlicht in: | The Journal of thoracic and cardiovascular surgery 2013-03, Vol.145 (3), p.S178-S185 |
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| container_title | The Journal of thoracic and cardiovascular surgery |
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| creator | Rahe-Meyer, Niels, MD, MSc, PhD Hanke, Alexander, MD Schmidt, Dirk S., PhD Hagl, Christian, MD Pichlmaier, Maximilian, MD |
| description | Objectives We assessed whether fibrinogen concentrate as targeted first-line hemostatic therapy was more effective than placebo or a standardized transfusion algorithm in controlling coagulopathic bleeding in patients undergoing major aortic surgery. Methods In this single-center, prospective, double-blind study, adults undergoing elective thoracic or thoracoabdominal aortic replacement surgery involving cardiopulmonary bypass were randomized to intraoperative fibrinogen concentrate (n = 29) or placebo (n = 32). Study medication was given if patients had clinically relevant coagulopathic bleeding, measured by 5-minute bleeding mass, after cardiopulmonary bypass removal, protamine administration, and surgical hemostasis. Fibrinogen concentrate dosing was individualized using the thromboelastometric FIBTEM test. If bleeding continued, a standardized transfusion algorithm was followed. In the placebo group, all 32 patients received 1 transfusion cycle of fresh-frozen plasma/platelets, and 30 patients required a second transfusion cycle; none of these patients received any other procoagulant therapy. Change in bleeding rate after treatment was compared using t tests. Results Mean change in bleeding rate after fibrinogen concentrate was −48.3 g/5 min, compared with 0.4 g/5 min after placebo ( P |
| doi_str_mv | 10.1016/j.jtcvs.2012.12.083 |
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Methods In this single-center, prospective, double-blind study, adults undergoing elective thoracic or thoracoabdominal aortic replacement surgery involving cardiopulmonary bypass were randomized to intraoperative fibrinogen concentrate (n = 29) or placebo (n = 32). Study medication was given if patients had clinically relevant coagulopathic bleeding, measured by 5-minute bleeding mass, after cardiopulmonary bypass removal, protamine administration, and surgical hemostasis. Fibrinogen concentrate dosing was individualized using the thromboelastometric FIBTEM test. If bleeding continued, a standardized transfusion algorithm was followed. In the placebo group, all 32 patients received 1 transfusion cycle of fresh-frozen plasma/platelets, and 30 patients required a second transfusion cycle; none of these patients received any other procoagulant therapy. Change in bleeding rate after treatment was compared using t tests. Results Mean change in bleeding rate after fibrinogen concentrate was −48.3 g/5 min, compared with 0.4 g/5 min after placebo ( P < .001), −16.1 g/5 min after 1 transfusion cycle (fresh-frozen plasma or platelets; P = .003), and −28.0 g/5 min after 2 transfusion cycles (fresh-frozen plasma and platelets; P = .11). Reductions in bleeding rate were greater for patients with higher bleeding rates before treatment, especially with fibrinogen concentrate. Conclusions FIBTEM-guided intraoperative hemostatic therapy with fibrinogen concentrate is more effective than placebo in controlling coagulopathic bleeding during major aortic replacement surgery. Fibrinogen concentrate is also more effective than 1 cycle of fresh-frozen plasma/platelets and is more rapid than—and at least as effective as—2 cycles of fresh-frozen plasma/platelets.</description><identifier>ISSN: 0022-5223</identifier><identifier>EISSN: 1097-685X</identifier><identifier>DOI: 10.1016/j.jtcvs.2012.12.083</identifier><identifier>PMID: 23410777</identifier><language>eng</language><publisher>United States: Mosby, Inc</publisher><subject>Afibrinogenemia - blood ; Afibrinogenemia - complications ; Afibrinogenemia - therapy ; Algorithms ; Aorta, Thoracic - surgery ; Blood Loss, Surgical - prevention & control ; Blood Vessel Prosthesis Implantation - adverse effects ; Cardiopulmonary Bypass - adverse effects ; Cardiothoracic Surgery ; Double-Blind Method ; Female ; Fibrinogen - administration & dosage ; Germany ; Hemostatic Techniques ; Hemostatics - administration & dosage ; Humans ; Intraoperative Care ; Linear Models ; Male ; Middle Aged ; Plasma ; Platelet Transfusion ; Prospective Studies ; Thrombelastography ; Treatment Outcome</subject><ispartof>The Journal of thoracic and cardiovascular surgery, 2013-03, Vol.145 (3), p.S178-S185</ispartof><rights>2013</rights><rights>Copyright © 2013. Published by Mosby, Inc.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c525t-6f10392a0108af04c1f5f370ae59e191fe54a1d12d1e75d9646059913ba95f763</citedby><cites>FETCH-LOGICAL-c525t-6f10392a0108af04c1f5f370ae59e191fe54a1d12d1e75d9646059913ba95f763</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.jtcvs.2012.12.083$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23410777$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Rahe-Meyer, Niels, MD, MSc, PhD</creatorcontrib><creatorcontrib>Hanke, Alexander, MD</creatorcontrib><creatorcontrib>Schmidt, Dirk S., PhD</creatorcontrib><creatorcontrib>Hagl, Christian, MD</creatorcontrib><creatorcontrib>Pichlmaier, Maximilian, MD</creatorcontrib><title>Fibrinogen concentrate reduces intraoperative bleeding when used as first-line hemostatic therapy during major aortic replacement surgery: Results from a randomized, placebo-controlled trial</title><title>The Journal of thoracic and cardiovascular surgery</title><addtitle>J Thorac Cardiovasc Surg</addtitle><description>Objectives We assessed whether fibrinogen concentrate as targeted first-line hemostatic therapy was more effective than placebo or a standardized transfusion algorithm in controlling coagulopathic bleeding in patients undergoing major aortic surgery. Methods In this single-center, prospective, double-blind study, adults undergoing elective thoracic or thoracoabdominal aortic replacement surgery involving cardiopulmonary bypass were randomized to intraoperative fibrinogen concentrate (n = 29) or placebo (n = 32). Study medication was given if patients had clinically relevant coagulopathic bleeding, measured by 5-minute bleeding mass, after cardiopulmonary bypass removal, protamine administration, and surgical hemostasis. Fibrinogen concentrate dosing was individualized using the thromboelastometric FIBTEM test. If bleeding continued, a standardized transfusion algorithm was followed. In the placebo group, all 32 patients received 1 transfusion cycle of fresh-frozen plasma/platelets, and 30 patients required a second transfusion cycle; none of these patients received any other procoagulant therapy. Change in bleeding rate after treatment was compared using t tests. Results Mean change in bleeding rate after fibrinogen concentrate was −48.3 g/5 min, compared with 0.4 g/5 min after placebo ( P < .001), −16.1 g/5 min after 1 transfusion cycle (fresh-frozen plasma or platelets; P = .003), and −28.0 g/5 min after 2 transfusion cycles (fresh-frozen plasma and platelets; P = .11). Reductions in bleeding rate were greater for patients with higher bleeding rates before treatment, especially with fibrinogen concentrate. Conclusions FIBTEM-guided intraoperative hemostatic therapy with fibrinogen concentrate is more effective than placebo in controlling coagulopathic bleeding during major aortic replacement surgery. Fibrinogen concentrate is also more effective than 1 cycle of fresh-frozen plasma/platelets and is more rapid than—and at least as effective as—2 cycles of fresh-frozen plasma/platelets.</description><subject>Afibrinogenemia - blood</subject><subject>Afibrinogenemia - complications</subject><subject>Afibrinogenemia - therapy</subject><subject>Algorithms</subject><subject>Aorta, Thoracic - surgery</subject><subject>Blood Loss, Surgical - prevention & control</subject><subject>Blood Vessel Prosthesis Implantation - adverse effects</subject><subject>Cardiopulmonary Bypass - adverse effects</subject><subject>Cardiothoracic Surgery</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Fibrinogen - administration & dosage</subject><subject>Germany</subject><subject>Hemostatic Techniques</subject><subject>Hemostatics - administration & dosage</subject><subject>Humans</subject><subject>Intraoperative Care</subject><subject>Linear Models</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Plasma</subject><subject>Platelet Transfusion</subject><subject>Prospective Studies</subject><subject>Thrombelastography</subject><subject>Treatment Outcome</subject><issn>0022-5223</issn><issn>1097-685X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkt-K1DAUxoso7uzqEwiSSy_seJJO24mgIIurwoLgH_AuZJLTmdS0GU_SkfHh9tlMd1YvvBECIcn3O1-S7xTFEw5LDrx50S_7ZA5xKYCLZR6wru4VCw6yLZt1_e1-sQAQoqyFqM6K8xh7AGiBy4fFmahWHNq2XRQ3V25DbgxbHJkJo8ExkU7ICO1kMDI3r8Me86Y7INt4ROvGLfu5y8AU0TIdWecoptK7EdkOhxBTFhuWdpnaH5mdaCYG3QdiOtB8Rrj32uCQ7VicaIt0fMk-YZx8yuUoDEwz0qMNg_uF9jm7VW9Cma-YKHiffRM57R8VDzrtIz6-my-Kr1dvv1y-L68_vvtw-ea6NLWoU9l0HCopNHBY6w5Whnd1V7WgsZbIJe-wXmluubAc29rKZtVALSWvNlrWXdtUF8WzU909hR8TxqQGFw16r0cMU1RcrOWqbbicpdVJaijESNipPblB01FxUHNwqle3wak5uEyqHFymnt4ZTJsB7V_mT1JZ8OokwPzMg0NS0TjMgVlHaJKywf3H4PU_vMmBOaP9dzxi7MNEY_5BxVXMgPo8987cOrzKbQMCqt_SdMTr</recordid><startdate>20130301</startdate><enddate>20130301</enddate><creator>Rahe-Meyer, Niels, MD, MSc, PhD</creator><creator>Hanke, Alexander, MD</creator><creator>Schmidt, Dirk S., PhD</creator><creator>Hagl, Christian, MD</creator><creator>Pichlmaier, Maximilian, MD</creator><general>Mosby, Inc</general><scope>6I.</scope><scope>AAFTH</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>20130301</creationdate><title>Fibrinogen concentrate reduces intraoperative bleeding when used as first-line hemostatic therapy during major aortic replacement surgery: Results from a randomized, placebo-controlled trial</title><author>Rahe-Meyer, Niels, MD, MSc, PhD ; Hanke, Alexander, MD ; Schmidt, Dirk S., PhD ; Hagl, Christian, MD ; Pichlmaier, Maximilian, MD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c525t-6f10392a0108af04c1f5f370ae59e191fe54a1d12d1e75d9646059913ba95f763</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Afibrinogenemia - blood</topic><topic>Afibrinogenemia - complications</topic><topic>Afibrinogenemia - therapy</topic><topic>Algorithms</topic><topic>Aorta, Thoracic - surgery</topic><topic>Blood Loss, Surgical - prevention & control</topic><topic>Blood Vessel Prosthesis Implantation - adverse effects</topic><topic>Cardiopulmonary Bypass - adverse effects</topic><topic>Cardiothoracic Surgery</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Fibrinogen - administration & dosage</topic><topic>Germany</topic><topic>Hemostatic Techniques</topic><topic>Hemostatics - administration & dosage</topic><topic>Humans</topic><topic>Intraoperative Care</topic><topic>Linear Models</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Plasma</topic><topic>Platelet Transfusion</topic><topic>Prospective Studies</topic><topic>Thrombelastography</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Rahe-Meyer, Niels, MD, MSc, PhD</creatorcontrib><creatorcontrib>Hanke, Alexander, MD</creatorcontrib><creatorcontrib>Schmidt, Dirk S., PhD</creatorcontrib><creatorcontrib>Hagl, Christian, MD</creatorcontrib><creatorcontrib>Pichlmaier, Maximilian, MD</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><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><jtitle>The Journal of thoracic and cardiovascular surgery</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Rahe-Meyer, Niels, MD, MSc, PhD</au><au>Hanke, Alexander, MD</au><au>Schmidt, Dirk S., PhD</au><au>Hagl, Christian, MD</au><au>Pichlmaier, Maximilian, MD</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Fibrinogen concentrate reduces intraoperative bleeding when used as first-line hemostatic therapy during major aortic replacement surgery: Results from a randomized, placebo-controlled trial</atitle><jtitle>The Journal of thoracic and cardiovascular surgery</jtitle><addtitle>J Thorac Cardiovasc Surg</addtitle><date>2013-03-01</date><risdate>2013</risdate><volume>145</volume><issue>3</issue><spage>S178</spage><epage>S185</epage><pages>S178-S185</pages><issn>0022-5223</issn><eissn>1097-685X</eissn><abstract>Objectives We assessed whether fibrinogen concentrate as targeted first-line hemostatic therapy was more effective than placebo or a standardized transfusion algorithm in controlling coagulopathic bleeding in patients undergoing major aortic surgery. Methods In this single-center, prospective, double-blind study, adults undergoing elective thoracic or thoracoabdominal aortic replacement surgery involving cardiopulmonary bypass were randomized to intraoperative fibrinogen concentrate (n = 29) or placebo (n = 32). Study medication was given if patients had clinically relevant coagulopathic bleeding, measured by 5-minute bleeding mass, after cardiopulmonary bypass removal, protamine administration, and surgical hemostasis. Fibrinogen concentrate dosing was individualized using the thromboelastometric FIBTEM test. If bleeding continued, a standardized transfusion algorithm was followed. In the placebo group, all 32 patients received 1 transfusion cycle of fresh-frozen plasma/platelets, and 30 patients required a second transfusion cycle; none of these patients received any other procoagulant therapy. Change in bleeding rate after treatment was compared using t tests. Results Mean change in bleeding rate after fibrinogen concentrate was −48.3 g/5 min, compared with 0.4 g/5 min after placebo ( P < .001), −16.1 g/5 min after 1 transfusion cycle (fresh-frozen plasma or platelets; P = .003), and −28.0 g/5 min after 2 transfusion cycles (fresh-frozen plasma and platelets; P = .11). Reductions in bleeding rate were greater for patients with higher bleeding rates before treatment, especially with fibrinogen concentrate. Conclusions FIBTEM-guided intraoperative hemostatic therapy with fibrinogen concentrate is more effective than placebo in controlling coagulopathic bleeding during major aortic replacement surgery. Fibrinogen concentrate is also more effective than 1 cycle of fresh-frozen plasma/platelets and is more rapid than—and at least as effective as—2 cycles of fresh-frozen plasma/platelets.</abstract><cop>United States</cop><pub>Mosby, Inc</pub><pmid>23410777</pmid><doi>10.1016/j.jtcvs.2012.12.083</doi><oa>free_for_read</oa></addata></record> |
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| subjects | Afibrinogenemia - blood Afibrinogenemia - complications Afibrinogenemia - therapy Algorithms Aorta, Thoracic - surgery Blood Loss, Surgical - prevention & control Blood Vessel Prosthesis Implantation - adverse effects Cardiopulmonary Bypass - adverse effects Cardiothoracic Surgery Double-Blind Method Female Fibrinogen - administration & dosage Germany Hemostatic Techniques Hemostatics - administration & dosage Humans Intraoperative Care Linear Models Male Middle Aged Plasma Platelet Transfusion Prospective Studies Thrombelastography Treatment Outcome |
| title | Fibrinogen concentrate reduces intraoperative bleeding when used as first-line hemostatic therapy during major aortic replacement surgery: Results from a randomized, placebo-controlled trial |
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