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Rotational thromboelastometry‐guided blood component use in cirrhotic children undergoing invasive procedures: Randomized controlled trial

Background & Aims This randomized controlled trial (RCT) was conducted with the aim to evaluate the efficacy and safety of using ROTEM‐based transfusion strategy in cirrhotic children undergoing invasive procedures. Methods This was an open‐label, RCT which included (i) children under 18 years o...

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Published in:Liver international 2022-11, Vol.42 (11), p.2492-2500
Main Authors: Maria, Arjun, Lal, Bikrant B., Khanna, Rajeev, Sood, Vikrant, Mukund, Amar, Bajpai, Meenu, Alam, Seema
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container_issue 11
container_start_page 2492
container_title Liver international
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creator Maria, Arjun
Lal, Bikrant B.
Khanna, Rajeev
Sood, Vikrant
Mukund, Amar
Bajpai, Meenu
Alam, Seema
description Background & Aims This randomized controlled trial (RCT) was conducted with the aim to evaluate the efficacy and safety of using ROTEM‐based transfusion strategy in cirrhotic children undergoing invasive procedures. Methods This was an open‐label, RCT which included (i) children under 18 years of age with liver cirrhosis; (ii) INR between 1.5 and 2.5; and/or (iii) platelet count between 20 × 109/L and 50 × 109/L (for procedures other than liver biopsy) and between 40 × 109/L and 60 × 109/L (for liver biopsy); and (iv) listed for invasive procedures. Stratified randomization was done for children undergoing liver biopsies. Patients randomized to the ROTEM and conventional groups received blood component transfusion using predefined criteria. Results A total of 423 invasive procedures were screened for inclusion of which 60 were randomized (30 in each group with comparable baseline parameters). The volume of total blood components, fresh frozen plasma (FFP) and platelets transfused was significantly lower in ROTEM as compared to conventional group. Only 46.7% of children in ROTEM group received a blood component compared to 100% in conventional group (p 
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Methods This was an open‐label, RCT which included (i) children under 18 years of age with liver cirrhosis; (ii) INR between 1.5 and 2.5; and/or (iii) platelet count between 20 × 109/L and 50 × 109/L (for procedures other than liver biopsy) and between 40 × 109/L and 60 × 109/L (for liver biopsy); and (iv) listed for invasive procedures. Stratified randomization was done for children undergoing liver biopsies. Patients randomized to the ROTEM and conventional groups received blood component transfusion using predefined criteria. Results A total of 423 invasive procedures were screened for inclusion of which 60 were randomized (30 in each group with comparable baseline parameters). The volume of total blood components, fresh frozen plasma (FFP) and platelets transfused was significantly lower in ROTEM as compared to conventional group. Only 46.7% of children in ROTEM group received a blood component compared to 100% in conventional group (p &lt; .001). The requirement of FFP (ROTEM: 43.3%, Conventional: 83.3%, p = .001) was significantly lower in the patients receiving ROTEM‐guided transfusions. There was no difference in procedure‐related bleed and transfusion‐related complications between the two groups. ROTEM was cost‐effective (p = .002) despite the additional cost of the test. Conclusion ROTEM‐based transfusion strategies result in lower blood component transfusion in cirrhotic children undergoing invasive procedures without an increase in risk of procedure‐related bleed. ROTEM‐guided transfusion strategy is cost‐effective.</description><identifier>ISSN: 1478-3223</identifier><identifier>EISSN: 1478-3231</identifier><identifier>DOI: 10.1111/liv.15398</identifier><language>eng</language><publisher>Hoboken: Wiley Subscription Services, Inc</publisher><subject>Biopsy ; Blood transfusion ; Children ; Cirrhosis ; Clinical trials ; Complications ; cost‐effectiveness ; invasive procedures in cirrhotic children ; Liver ; liver biopsy ; Liver cirrhosis ; Platelets ; Randomization ; rotational thromoelastometry ; ROTEM‐guided blood component transfusion ; Strategy ; Transfusion ; viscoelastic tests in cirrhotic children</subject><ispartof>Liver international, 2022-11, Vol.42 (11), p.2492-2500</ispartof><rights>2022 John Wiley &amp; Sons A/S. Published by John Wiley &amp; Sons Ltd.</rights><rights>2022 John Wiley &amp; Sons A/S</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c2608-54a046c0db997b06d69e54327769ba23a845739bc6d963b394680b83cfc0a5a93</citedby><cites>FETCH-LOGICAL-c2608-54a046c0db997b06d69e54327769ba23a845739bc6d963b394680b83cfc0a5a93</cites><orcidid>0000-0001-6275-7736 ; 0000-0002-5024-4084 ; 0000-0002-8905-5889 ; 0000-0003-0888-8625</orcidid></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></links><search><creatorcontrib>Maria, Arjun</creatorcontrib><creatorcontrib>Lal, Bikrant B.</creatorcontrib><creatorcontrib>Khanna, Rajeev</creatorcontrib><creatorcontrib>Sood, Vikrant</creatorcontrib><creatorcontrib>Mukund, Amar</creatorcontrib><creatorcontrib>Bajpai, Meenu</creatorcontrib><creatorcontrib>Alam, Seema</creatorcontrib><title>Rotational thromboelastometry‐guided blood component use in cirrhotic children undergoing invasive procedures: Randomized controlled trial</title><title>Liver international</title><description>Background &amp; Aims This randomized controlled trial (RCT) was conducted with the aim to evaluate the efficacy and safety of using ROTEM‐based transfusion strategy in cirrhotic children undergoing invasive procedures. Methods This was an open‐label, RCT which included (i) children under 18 years of age with liver cirrhosis; (ii) INR between 1.5 and 2.5; and/or (iii) platelet count between 20 × 109/L and 50 × 109/L (for procedures other than liver biopsy) and between 40 × 109/L and 60 × 109/L (for liver biopsy); and (iv) listed for invasive procedures. Stratified randomization was done for children undergoing liver biopsies. Patients randomized to the ROTEM and conventional groups received blood component transfusion using predefined criteria. Results A total of 423 invasive procedures were screened for inclusion of which 60 were randomized (30 in each group with comparable baseline parameters). The volume of total blood components, fresh frozen plasma (FFP) and platelets transfused was significantly lower in ROTEM as compared to conventional group. Only 46.7% of children in ROTEM group received a blood component compared to 100% in conventional group (p &lt; .001). The requirement of FFP (ROTEM: 43.3%, Conventional: 83.3%, p = .001) was significantly lower in the patients receiving ROTEM‐guided transfusions. There was no difference in procedure‐related bleed and transfusion‐related complications between the two groups. ROTEM was cost‐effective (p = .002) despite the additional cost of the test. Conclusion ROTEM‐based transfusion strategies result in lower blood component transfusion in cirrhotic children undergoing invasive procedures without an increase in risk of procedure‐related bleed. ROTEM‐guided transfusion strategy is cost‐effective.</description><subject>Biopsy</subject><subject>Blood transfusion</subject><subject>Children</subject><subject>Cirrhosis</subject><subject>Clinical trials</subject><subject>Complications</subject><subject>cost‐effectiveness</subject><subject>invasive procedures in cirrhotic children</subject><subject>Liver</subject><subject>liver biopsy</subject><subject>Liver cirrhosis</subject><subject>Platelets</subject><subject>Randomization</subject><subject>rotational thromoelastometry</subject><subject>ROTEM‐guided blood component transfusion</subject><subject>Strategy</subject><subject>Transfusion</subject><subject>viscoelastic tests in cirrhotic children</subject><issn>1478-3223</issn><issn>1478-3231</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><recordid>eNp1kcGKFDEQhoMouI4efIOAFz3MbtLpTjreZHHdhQFhUa9NOqmZyZJOjUl6ZPbkA3jwGX2SzTjiQbAu9R---in-n5CXnJ3zOhfB7895J3T_iJzxVvVL0Qj--K9uxFPyLOc7xrjWHT8jP26xmOIxmkDLNuE0IgSTC05Q0uHX95-b2TtwdAyIjlqcdhghFjpnoD5S61PaYvGW2q0PLkGkc3SQNujjpgJ7k_0e6C6hBTcnyG_prYkOJ38PR7tYEoZQZUnehOfkydqEDC_-7AX5fPX-0-X1cvXxw83lu9XSNpL1y641rJWWuVFrNTLppIauFY1SUo-mEaZvOyX0aKXTUoxCt7JnYy_s2jLTGS0W5PXJt_71dYZchslnCyGYCDjnoVGsJqg6JSv66h_0DudU0zpSXPVSqZrwgrw5UTZhzgnWwy75yaTDwNlw7GWovQy_e6nsxYn95gMc_g8Oq5svp4sH7ZuTWQ</recordid><startdate>202211</startdate><enddate>202211</enddate><creator>Maria, Arjun</creator><creator>Lal, Bikrant B.</creator><creator>Khanna, Rajeev</creator><creator>Sood, Vikrant</creator><creator>Mukund, Amar</creator><creator>Bajpai, Meenu</creator><creator>Alam, Seema</creator><general>Wiley Subscription Services, Inc</general><scope>AAYXX</scope><scope>CITATION</scope><scope>7QO</scope><scope>7T5</scope><scope>7U9</scope><scope>8FD</scope><scope>FR3</scope><scope>H94</scope><scope>P64</scope><scope>RC3</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0001-6275-7736</orcidid><orcidid>https://orcid.org/0000-0002-5024-4084</orcidid><orcidid>https://orcid.org/0000-0002-8905-5889</orcidid><orcidid>https://orcid.org/0000-0003-0888-8625</orcidid></search><sort><creationdate>202211</creationdate><title>Rotational thromboelastometry‐guided blood component use in cirrhotic children undergoing invasive procedures: Randomized controlled trial</title><author>Maria, Arjun ; Lal, Bikrant B. ; Khanna, Rajeev ; Sood, Vikrant ; Mukund, Amar ; Bajpai, Meenu ; Alam, Seema</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c2608-54a046c0db997b06d69e54327769ba23a845739bc6d963b394680b83cfc0a5a93</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Biopsy</topic><topic>Blood transfusion</topic><topic>Children</topic><topic>Cirrhosis</topic><topic>Clinical trials</topic><topic>Complications</topic><topic>cost‐effectiveness</topic><topic>invasive procedures in cirrhotic children</topic><topic>Liver</topic><topic>liver biopsy</topic><topic>Liver cirrhosis</topic><topic>Platelets</topic><topic>Randomization</topic><topic>rotational thromoelastometry</topic><topic>ROTEM‐guided blood component transfusion</topic><topic>Strategy</topic><topic>Transfusion</topic><topic>viscoelastic tests in cirrhotic children</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Maria, Arjun</creatorcontrib><creatorcontrib>Lal, Bikrant B.</creatorcontrib><creatorcontrib>Khanna, Rajeev</creatorcontrib><creatorcontrib>Sood, Vikrant</creatorcontrib><creatorcontrib>Mukund, Amar</creatorcontrib><creatorcontrib>Bajpai, Meenu</creatorcontrib><creatorcontrib>Alam, Seema</creatorcontrib><collection>CrossRef</collection><collection>Biotechnology Research Abstracts</collection><collection>Immunology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Technology Research Database</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Liver international</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Maria, Arjun</au><au>Lal, Bikrant B.</au><au>Khanna, Rajeev</au><au>Sood, Vikrant</au><au>Mukund, Amar</au><au>Bajpai, Meenu</au><au>Alam, Seema</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Rotational thromboelastometry‐guided blood component use in cirrhotic children undergoing invasive procedures: Randomized controlled trial</atitle><jtitle>Liver international</jtitle><date>2022-11</date><risdate>2022</risdate><volume>42</volume><issue>11</issue><spage>2492</spage><epage>2500</epage><pages>2492-2500</pages><issn>1478-3223</issn><eissn>1478-3231</eissn><abstract>Background &amp; Aims This randomized controlled trial (RCT) was conducted with the aim to evaluate the efficacy and safety of using ROTEM‐based transfusion strategy in cirrhotic children undergoing invasive procedures. Methods This was an open‐label, RCT which included (i) children under 18 years of age with liver cirrhosis; (ii) INR between 1.5 and 2.5; and/or (iii) platelet count between 20 × 109/L and 50 × 109/L (for procedures other than liver biopsy) and between 40 × 109/L and 60 × 109/L (for liver biopsy); and (iv) listed for invasive procedures. Stratified randomization was done for children undergoing liver biopsies. Patients randomized to the ROTEM and conventional groups received blood component transfusion using predefined criteria. Results A total of 423 invasive procedures were screened for inclusion of which 60 were randomized (30 in each group with comparable baseline parameters). The volume of total blood components, fresh frozen plasma (FFP) and platelets transfused was significantly lower in ROTEM as compared to conventional group. Only 46.7% of children in ROTEM group received a blood component compared to 100% in conventional group (p &lt; .001). The requirement of FFP (ROTEM: 43.3%, Conventional: 83.3%, p = .001) was significantly lower in the patients receiving ROTEM‐guided transfusions. There was no difference in procedure‐related bleed and transfusion‐related complications between the two groups. ROTEM was cost‐effective (p = .002) despite the additional cost of the test. Conclusion ROTEM‐based transfusion strategies result in lower blood component transfusion in cirrhotic children undergoing invasive procedures without an increase in risk of procedure‐related bleed. ROTEM‐guided transfusion strategy is cost‐effective.</abstract><cop>Hoboken</cop><pub>Wiley Subscription Services, Inc</pub><doi>10.1111/liv.15398</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0001-6275-7736</orcidid><orcidid>https://orcid.org/0000-0002-5024-4084</orcidid><orcidid>https://orcid.org/0000-0002-8905-5889</orcidid><orcidid>https://orcid.org/0000-0003-0888-8625</orcidid></addata></record>
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source Wiley-Blackwell Read & Publish Collection
subjects Biopsy
Blood transfusion
Children
Cirrhosis
Clinical trials
Complications
cost‐effectiveness
invasive procedures in cirrhotic children
Liver
liver biopsy
Liver cirrhosis
Platelets
Randomization
rotational thromoelastometry
ROTEM‐guided blood component transfusion
Strategy
Transfusion
viscoelastic tests in cirrhotic children
title Rotational thromboelastometry‐guided blood component use in cirrhotic children undergoing invasive procedures: Randomized controlled trial
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