A Randomized Pilot Trial Assessing the Role of Human Fibrinogen Concentrate in Decreasing Cryoprecipitate Use and Blood Loss in Infants Undergoing Cardiopulmonary Bypass
The objective of this study was to determine whether treatment with human fibrinogen concentrate decreases the need for component blood therapy and blood loss in neonate and infant patients undergoing cardiopulmonary bypass. Pediatric patients ( N = 30) undergoing elective cardiac surgery were rand...
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| Veröffentlicht in: | Pediatric cardiology 2022-10, Vol.43 (7), p.1444-1454 |
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| creator | Tirotta, Christopher F. Lagueruela, Richard G. Gupta, Apeksha Salyakina, Daria Aguero, David Ojito, Jorge Kubes, Kathleen Hannan, Robert Burke, Redmond P. |
| description | The objective of this study was to determine whether treatment with human fibrinogen concentrate decreases the need for component blood therapy and blood loss in neonate and infant patients undergoing cardiopulmonary bypass. Pediatric patients (
N
= 30) undergoing elective cardiac surgery were randomized to receive human fibrinogen concentrate or placebo following cardiopulmonary bypass termination. The primary endpoint was the amount of cryoprecipitate administered. Secondary endpoints included estimated blood loss during the 24 h post-surgery; perioperative blood product transfusion; effects of fibrinogen infusion on global hemostasis, measured by laboratory testing and rotational thromboelastometry; and adverse events. No clinically significant differences were identified in baseline characteristics between groups. A significantly lower volume of cryoprecipitate was administered to the treatment group during the perioperative period [median (interquartile range) 0.0 (0.0–0.0) cc/kg vs 12.0 (8.2–14.3) cc/kg;
P
|
| doi_str_mv | 10.1007/s00246-022-02866-4 |
| format | Article |
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N
= 30) undergoing elective cardiac surgery were randomized to receive human fibrinogen concentrate or placebo following cardiopulmonary bypass termination. The primary endpoint was the amount of cryoprecipitate administered. Secondary endpoints included estimated blood loss during the 24 h post-surgery; perioperative blood product transfusion; effects of fibrinogen infusion on global hemostasis, measured by laboratory testing and rotational thromboelastometry; and adverse events. No clinically significant differences were identified in baseline characteristics between groups. A significantly lower volume of cryoprecipitate was administered to the treatment group during the perioperative period [median (interquartile range) 0.0 (0.0–0.0) cc/kg vs 12.0 (8.2–14.3) cc/kg;
P
< 0.0001] versus placebo. No difference was observed between treatment groups in blood loss, laboratory coagulation tests, use of other blood components, or incidence of adverse events. FIBTEM amplitude of maximum clot firmness values was significantly higher among patients treated with human fibrinogen concentrate versus placebo (
P
≤ 0.0001). No significant differences were observed in post-drug HEPTEM, INTEM, and EXTEM results. Human fibrinogen concentrate (70 mg/kg) administered after the termination of cardiopulmonary bypass reduced the need for transfusion with cryoprecipitate in a neonate and infant patient population.
ClinicalTrials.gov identifier
: NCT02822599.</description><identifier>ISSN: 0172-0643</identifier><identifier>EISSN: 1432-1971</identifier><identifier>DOI: 10.1007/s00246-022-02866-4</identifier><identifier>PMID: 35305111</identifier><language>eng</language><publisher>New York: Springer US</publisher><subject>Cardiac Surgery ; Cardiology ; Medicine ; Medicine & Public Health ; NCT ; NCT02822599 ; Original ; Original Article ; Vascular Surgery</subject><ispartof>Pediatric cardiology, 2022-10, Vol.43 (7), p.1444-1454</ispartof><rights>The Author(s) 2022</rights><rights>2022. The Author(s).</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c446t-9cb221b922b72a985f8b259e1a0b2caa0c733c65d45f8039a24398eed10ccfe33</citedby><cites>FETCH-LOGICAL-c446t-9cb221b922b72a985f8b259e1a0b2caa0c733c65d45f8039a24398eed10ccfe33</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00246-022-02866-4$$EPDF$$P50$$Gspringer$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00246-022-02866-4$$EHTML$$P50$$Gspringer$$Hfree_for_read</linktohtml><link.rule.ids>230,314,780,784,885,27923,27924,41487,42556,51318</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/35305111$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Tirotta, Christopher F.</creatorcontrib><creatorcontrib>Lagueruela, Richard G.</creatorcontrib><creatorcontrib>Gupta, Apeksha</creatorcontrib><creatorcontrib>Salyakina, Daria</creatorcontrib><creatorcontrib>Aguero, David</creatorcontrib><creatorcontrib>Ojito, Jorge</creatorcontrib><creatorcontrib>Kubes, Kathleen</creatorcontrib><creatorcontrib>Hannan, Robert</creatorcontrib><creatorcontrib>Burke, Redmond P.</creatorcontrib><title>A Randomized Pilot Trial Assessing the Role of Human Fibrinogen Concentrate in Decreasing Cryoprecipitate Use and Blood Loss in Infants Undergoing Cardiopulmonary Bypass</title><title>Pediatric cardiology</title><addtitle>Pediatr Cardiol</addtitle><addtitle>Pediatr Cardiol</addtitle><description>The objective of this study was to determine whether treatment with human fibrinogen concentrate decreases the need for component blood therapy and blood loss in neonate and infant patients undergoing cardiopulmonary bypass. Pediatric patients (
N
= 30) undergoing elective cardiac surgery were randomized to receive human fibrinogen concentrate or placebo following cardiopulmonary bypass termination. The primary endpoint was the amount of cryoprecipitate administered. Secondary endpoints included estimated blood loss during the 24 h post-surgery; perioperative blood product transfusion; effects of fibrinogen infusion on global hemostasis, measured by laboratory testing and rotational thromboelastometry; and adverse events. No clinically significant differences were identified in baseline characteristics between groups. A significantly lower volume of cryoprecipitate was administered to the treatment group during the perioperative period [median (interquartile range) 0.0 (0.0–0.0) cc/kg vs 12.0 (8.2–14.3) cc/kg;
P
< 0.0001] versus placebo. No difference was observed between treatment groups in blood loss, laboratory coagulation tests, use of other blood components, or incidence of adverse events. FIBTEM amplitude of maximum clot firmness values was significantly higher among patients treated with human fibrinogen concentrate versus placebo (
P
≤ 0.0001). No significant differences were observed in post-drug HEPTEM, INTEM, and EXTEM results. Human fibrinogen concentrate (70 mg/kg) administered after the termination of cardiopulmonary bypass reduced the need for transfusion with cryoprecipitate in a neonate and infant patient population.
ClinicalTrials.gov identifier
: NCT02822599.</description><subject>Cardiac Surgery</subject><subject>Cardiology</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>NCT</subject><subject>NCT02822599</subject><subject>Original</subject><subject>Original Article</subject><subject>Vascular Surgery</subject><issn>0172-0643</issn><issn>1432-1971</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>C6C</sourceid><recordid>eNp9Uctu1DAUtRAVHVp-gAXykk3Arzy8QZoOlFYaqVXVWVuOc5O6SuxgJ5WGP-Iv8UxKBRsWV3dxHvdxEHpPySdKSPk5EsJEkRHGUlVFkYlXaEUFZxmVJX2NVoSWCSoEP0VvY3wkhFSkyt-gU55zklNKV-jXGt9p1_jB_oQG39reT_g-WN3jdYwQo3Udnh4A3_kesG_x1Txohy9tHazzHTi88c6Am4KeAFuHv4IJoI-yTdj7MYCxo50O6C4CTqPwRe99g7c-xoPg2rXaTRHvXAOh80ehDo3149wP3umwxxf7Ucd4jk5a3Ud499zP0O7y2_3mKtvefL_erLeZEaKYMmlqxmgtGatLpmWVt1XNcglUk5oZrYkpOTdF3oiEEC41E1xWAA0lxrTA-Rn6sviOcz1AsxzXqzHYIS2jvLbqX8TZB9X5JyVFJfMyTwYfnw2C_zFDnNRgo4G-1w78HBUrBJGSClElKluoJqR3BGhfxlCiDhmrJWOVMlbHjJVIog9_L_gi-RNqIvCFEBPkOgjq0c_Bpaf9z_Y3UZm2Zg</recordid><startdate>20221001</startdate><enddate>20221001</enddate><creator>Tirotta, Christopher F.</creator><creator>Lagueruela, Richard G.</creator><creator>Gupta, Apeksha</creator><creator>Salyakina, Daria</creator><creator>Aguero, David</creator><creator>Ojito, Jorge</creator><creator>Kubes, Kathleen</creator><creator>Hannan, Robert</creator><creator>Burke, Redmond P.</creator><general>Springer US</general><scope>C6C</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20221001</creationdate><title>A Randomized Pilot Trial Assessing the Role of Human Fibrinogen Concentrate in Decreasing Cryoprecipitate Use and Blood Loss in Infants Undergoing Cardiopulmonary Bypass</title><author>Tirotta, Christopher F. ; Lagueruela, Richard G. ; Gupta, Apeksha ; Salyakina, Daria ; Aguero, David ; Ojito, Jorge ; Kubes, Kathleen ; Hannan, Robert ; Burke, Redmond P.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c446t-9cb221b922b72a985f8b259e1a0b2caa0c733c65d45f8039a24398eed10ccfe33</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Cardiac Surgery</topic><topic>Cardiology</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>NCT</topic><topic>NCT02822599</topic><topic>Original</topic><topic>Original Article</topic><topic>Vascular Surgery</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Tirotta, Christopher F.</creatorcontrib><creatorcontrib>Lagueruela, Richard G.</creatorcontrib><creatorcontrib>Gupta, Apeksha</creatorcontrib><creatorcontrib>Salyakina, Daria</creatorcontrib><creatorcontrib>Aguero, David</creatorcontrib><creatorcontrib>Ojito, Jorge</creatorcontrib><creatorcontrib>Kubes, Kathleen</creatorcontrib><creatorcontrib>Hannan, Robert</creatorcontrib><creatorcontrib>Burke, Redmond P.</creatorcontrib><collection>Springer Nature OA Free Journals</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Pediatric cardiology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Tirotta, Christopher F.</au><au>Lagueruela, Richard G.</au><au>Gupta, Apeksha</au><au>Salyakina, Daria</au><au>Aguero, David</au><au>Ojito, Jorge</au><au>Kubes, Kathleen</au><au>Hannan, Robert</au><au>Burke, Redmond P.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A Randomized Pilot Trial Assessing the Role of Human Fibrinogen Concentrate in Decreasing Cryoprecipitate Use and Blood Loss in Infants Undergoing Cardiopulmonary Bypass</atitle><jtitle>Pediatric cardiology</jtitle><stitle>Pediatr Cardiol</stitle><addtitle>Pediatr Cardiol</addtitle><date>2022-10-01</date><risdate>2022</risdate><volume>43</volume><issue>7</issue><spage>1444</spage><epage>1454</epage><pages>1444-1454</pages><issn>0172-0643</issn><eissn>1432-1971</eissn><abstract>The objective of this study was to determine whether treatment with human fibrinogen concentrate decreases the need for component blood therapy and blood loss in neonate and infant patients undergoing cardiopulmonary bypass. Pediatric patients (
N
= 30) undergoing elective cardiac surgery were randomized to receive human fibrinogen concentrate or placebo following cardiopulmonary bypass termination. The primary endpoint was the amount of cryoprecipitate administered. Secondary endpoints included estimated blood loss during the 24 h post-surgery; perioperative blood product transfusion; effects of fibrinogen infusion on global hemostasis, measured by laboratory testing and rotational thromboelastometry; and adverse events. No clinically significant differences were identified in baseline characteristics between groups. A significantly lower volume of cryoprecipitate was administered to the treatment group during the perioperative period [median (interquartile range) 0.0 (0.0–0.0) cc/kg vs 12.0 (8.2–14.3) cc/kg;
P
< 0.0001] versus placebo. No difference was observed between treatment groups in blood loss, laboratory coagulation tests, use of other blood components, or incidence of adverse events. FIBTEM amplitude of maximum clot firmness values was significantly higher among patients treated with human fibrinogen concentrate versus placebo (
P
≤ 0.0001). No significant differences were observed in post-drug HEPTEM, INTEM, and EXTEM results. Human fibrinogen concentrate (70 mg/kg) administered after the termination of cardiopulmonary bypass reduced the need for transfusion with cryoprecipitate in a neonate and infant patient population.
ClinicalTrials.gov identifier
: NCT02822599.</abstract><cop>New York</cop><pub>Springer US</pub><pmid>35305111</pmid><doi>10.1007/s00246-022-02866-4</doi><tpages>11</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Pediatric cardiology, 2022-10, Vol.43 (7), p.1444-1454 |
| issn | 0172-0643 1432-1971 |
| language | eng |
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| source | SpringerLink Journals - AutoHoldings |
| subjects | Cardiac Surgery Cardiology Medicine Medicine & Public Health NCT NCT02822599 Original Original Article Vascular Surgery |
| title | A Randomized Pilot Trial Assessing the Role of Human Fibrinogen Concentrate in Decreasing Cryoprecipitate Use and Blood Loss in Infants Undergoing Cardiopulmonary Bypass |
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