Ferric derisomaltose and tranexamic acid, combined or alone, for reducing blood transfusion in patients with hip fracture (the HiFIT trial): a multicentre, 2 × 2 factorial, randomised, double-blind, controlled trial
Anaemia and blood transfusion are associated with poor outcomes after hip fracture. We evaluated the efficacy of intravenous iron and tranexamic acid in reducing blood transfusions after hip fracture surgery. In this double-blind, randomised, 2 × 2 factorial trial, we recruited adults hospitalised f...
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| Veröffentlicht in: | The Lancet. Haematology 2023-09, Vol.10 (9), p.e747-e755 |
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| creator | Lasocki, Sigismond Capdevila, Xavier Vielle, Bruno Bijok, Benjamin Lahlou-Casulli, Maria Collange, Vincent Grillot, Nicolas Danguy des Deserts, Marc Duchalais, Alexis Delannoy, Bertrand Drugeon, Bertrand Bouzat, Pierre David, Jean-Stéphane Rony, Louis Loupec, Thibault Léger, Maxime Rineau, Emmanuel Bouhours, Guillaume Lasocki, Sigismond Lebail, Adeline Léger, Maxime Parot-Schinkel, Elsa Rineau, Emmanuel Rony, Louis Vielle, Bruno Capdevilla, Xavier Loupec, Thibault Mounet, Benjamin Swisser, Fabien Danguy des Deserts, Marc Cinotti, Raphael Grillot, Nicolas Asehnoune, Karim Roquilly, Antoine Beloeil, Hélène Lahlou-Casulli, Maria Collange, Vincent Parent, Sébastien Delannoy, Bertrand Desebbe, Olivier Duchalais, Alexis Drugeon, Bertrand Guenezan, Jeremy Bouzat, Pierre Drevet, Sabine Gavazzi, Gaetan Greze, Jules Bijok, Benjamin Garrigue, Delphine David, Jean-Stéphane |
| description | Anaemia and blood transfusion are associated with poor outcomes after hip fracture. We evaluated the efficacy of intravenous iron and tranexamic acid in reducing blood transfusions after hip fracture surgery.
In this double-blind, randomised, 2 × 2 factorial trial, we recruited adults hospitalised for hip fractures in 12 medical centres in France who had preoperative haemoglobin concentrations between 9·5 and 13·0 g/dL. We randomly allocated participants (1:1:1:1), via a secure web-based service, to ferric derisomaltose (20 mg/kg intravenously) and tranexamic acid (1 g bolus followed by 1 g over 8 h intravenously at inclusion and 3 g topically during surgery), iron plus placebo (normal saline), tranexamic acid plus placebo, or double placebo. Unmasked nurses administered study drugs; participants and other clinical and research staff remained masked to treatment allocation. The primary outcome was the percentage of patients transfused during hospitalisation (or by day 30). The primary analysis included all randomised patients. This study is registered on ClinicalTrials.gov (NCT02972294) and is closed to new participants.
Of 413 patients (51–104 years old, median [IQR] 86 [78–91], 312 [76%] women, 101 [24%] men), 104 received iron plus tranexamic acid, 103 iron plus placebo, 103 tranexamic acid plus placebo, and 103 double placebo between March 31, 2017 and June 18, 2021 (study stopped early for efficacy after the planned interim analysis done on the first 390 patients included on May 25, 2021). Data for the primary outcome were available for all participants. Among patients on double placebo, 31 (30%) were transfused versus 16 (15%) on both drugs (relative risk 0·51 [98·3% CI 0·27−0·97]; p=0·012). 27 (26%) participants on iron (0·81 [0·50−1·29]; p=0·28) and 28 (27%) on tranexamic acid (0·85 [0·54−1·33]; p=0·39) were transfused. 487 adverse events were reported with similar event rates among the groups; among prespecified safety endpoints, severe postoperative anaemia (haemoglobin |
| doi_str_mv | 10.1016/S2352-3026(23)00163-1 |
| format | Article |
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In this double-blind, randomised, 2 × 2 factorial trial, we recruited adults hospitalised for hip fractures in 12 medical centres in France who had preoperative haemoglobin concentrations between 9·5 and 13·0 g/dL. We randomly allocated participants (1:1:1:1), via a secure web-based service, to ferric derisomaltose (20 mg/kg intravenously) and tranexamic acid (1 g bolus followed by 1 g over 8 h intravenously at inclusion and 3 g topically during surgery), iron plus placebo (normal saline), tranexamic acid plus placebo, or double placebo. Unmasked nurses administered study drugs; participants and other clinical and research staff remained masked to treatment allocation. The primary outcome was the percentage of patients transfused during hospitalisation (or by day 30). The primary analysis included all randomised patients. This study is registered on ClinicalTrials.gov (NCT02972294) and is closed to new participants.
Of 413 patients (51–104 years old, median [IQR] 86 [78–91], 312 [76%] women, 101 [24%] men), 104 received iron plus tranexamic acid, 103 iron plus placebo, 103 tranexamic acid plus placebo, and 103 double placebo between March 31, 2017 and June 18, 2021 (study stopped early for efficacy after the planned interim analysis done on the first 390 patients included on May 25, 2021). Data for the primary outcome were available for all participants. Among patients on double placebo, 31 (30%) were transfused versus 16 (15%) on both drugs (relative risk 0·51 [98·3% CI 0·27−0·97]; p=0·012). 27 (26%) participants on iron (0·81 [0·50−1·29]; p=0·28) and 28 (27%) on tranexamic acid (0·85 [0·54−1·33]; p=0·39) were transfused. 487 adverse events were reported with similar event rates among the groups; among prespecified safety endpoints, severe postoperative anaemia (haemoglobin <8 g/dL) was more frequent in the double placebo group. Main common adverse event were sepsis, pneumonia, and urinary infection, with similar rates among all groups.
In patients hospitalised for hip fracture surgery with a haemoglobin concentration 9·5–13·0 g/dL, preoperative infusion of ferric derisomaltose plus tranexamic acid reduced the risk of blood transfusion by 50%. Our results suggest that combining treatments from two different pillars improves patient blood-management programmes. Either treatment alone did not reduce transfusion rates, but we might not have had the power to detect it.
French Ministry of Health, HiFIT trial.</description><identifier>ISSN: 2352-3026</identifier><identifier>EISSN: 2352-3026</identifier><identifier>DOI: 10.1016/S2352-3026(23)00163-1</identifier><identifier>PMID: 37524101</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Anemia / drug therapy ; Anemia / etiology ; Blood Transfusion ; Double-Blind Method ; Female ; Hemoglobins ; Hip Fractures / chemically induced ; Hip Fractures / drug therapy ; Hip Fractures / surgery ; Human health and pathology ; Humans ; Iron / therapeutic use ; Life Sciences ; Male ; Middle Aged ; Tranexamic Acid / adverse effects ; Tranexamic Acid / therapeutic use ; Treatment Outcome</subject><ispartof>The Lancet. Haematology, 2023-09, Vol.10 (9), p.e747-e755</ispartof><rights>2023 Elsevier Ltd</rights><rights>Copyright © 2023 Elsevier Ltd. All rights reserved.</rights><rights>Distributed under a Creative Commons Attribution 4.0 International License</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c314t-1ab32feec7bb9985db74761e8f5b2449464ae166326810d5fd9ebf2db0265a003</citedby><cites>FETCH-LOGICAL-c314t-1ab32feec7bb9985db74761e8f5b2449464ae166326810d5fd9ebf2db0265a003</cites><orcidid>0000-0001-9217-8532 ; 0000-0002-5447-6595 ; 0000-0003-1026-7975</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37524101$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://hal.science/hal-04820325$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Lasocki, Sigismond</creatorcontrib><creatorcontrib>Capdevila, Xavier</creatorcontrib><creatorcontrib>Vielle, Bruno</creatorcontrib><creatorcontrib>Bijok, Benjamin</creatorcontrib><creatorcontrib>Lahlou-Casulli, Maria</creatorcontrib><creatorcontrib>Collange, Vincent</creatorcontrib><creatorcontrib>Grillot, Nicolas</creatorcontrib><creatorcontrib>Danguy des Deserts, Marc</creatorcontrib><creatorcontrib>Duchalais, Alexis</creatorcontrib><creatorcontrib>Delannoy, Bertrand</creatorcontrib><creatorcontrib>Drugeon, Bertrand</creatorcontrib><creatorcontrib>Bouzat, Pierre</creatorcontrib><creatorcontrib>David, Jean-Stéphane</creatorcontrib><creatorcontrib>Rony, Louis</creatorcontrib><creatorcontrib>Loupec, Thibault</creatorcontrib><creatorcontrib>Léger, Maxime</creatorcontrib><creatorcontrib>Rineau, Emmanuel</creatorcontrib><creatorcontrib>Bouhours, Guillaume</creatorcontrib><creatorcontrib>Lasocki, Sigismond</creatorcontrib><creatorcontrib>Lebail, Adeline</creatorcontrib><creatorcontrib>Léger, Maxime</creatorcontrib><creatorcontrib>Parot-Schinkel, Elsa</creatorcontrib><creatorcontrib>Rineau, Emmanuel</creatorcontrib><creatorcontrib>Rony, Louis</creatorcontrib><creatorcontrib>Vielle, Bruno</creatorcontrib><creatorcontrib>Capdevilla, Xavier</creatorcontrib><creatorcontrib>Loupec, Thibault</creatorcontrib><creatorcontrib>Mounet, Benjamin</creatorcontrib><creatorcontrib>Swisser, Fabien</creatorcontrib><creatorcontrib>Danguy des Deserts, Marc</creatorcontrib><creatorcontrib>Cinotti, Raphael</creatorcontrib><creatorcontrib>Grillot, Nicolas</creatorcontrib><creatorcontrib>Asehnoune, Karim</creatorcontrib><creatorcontrib>Roquilly, Antoine</creatorcontrib><creatorcontrib>Beloeil, Hélène</creatorcontrib><creatorcontrib>Lahlou-Casulli, Maria</creatorcontrib><creatorcontrib>Collange, Vincent</creatorcontrib><creatorcontrib>Parent, Sébastien</creatorcontrib><creatorcontrib>Delannoy, Bertrand</creatorcontrib><creatorcontrib>Desebbe, Olivier</creatorcontrib><creatorcontrib>Duchalais, Alexis</creatorcontrib><creatorcontrib>Drugeon, Bertrand</creatorcontrib><creatorcontrib>Guenezan, Jeremy</creatorcontrib><creatorcontrib>Bouzat, Pierre</creatorcontrib><creatorcontrib>Drevet, Sabine</creatorcontrib><creatorcontrib>Gavazzi, Gaetan</creatorcontrib><creatorcontrib>Greze, Jules</creatorcontrib><creatorcontrib>Bijok, Benjamin</creatorcontrib><creatorcontrib>Garrigue, Delphine</creatorcontrib><creatorcontrib>David, Jean-Stéphane</creatorcontrib><creatorcontrib>HiFIT Investigators</creatorcontrib><creatorcontrib>SFAR research network</creatorcontrib><title>Ferric derisomaltose and tranexamic acid, combined or alone, for reducing blood transfusion in patients with hip fracture (the HiFIT trial): a multicentre, 2 × 2 factorial, randomised, double-blind, controlled trial</title><title>The Lancet. Haematology</title><addtitle>Lancet Haematol</addtitle><description>Anaemia and blood transfusion are associated with poor outcomes after hip fracture. We evaluated the efficacy of intravenous iron and tranexamic acid in reducing blood transfusions after hip fracture surgery.
In this double-blind, randomised, 2 × 2 factorial trial, we recruited adults hospitalised for hip fractures in 12 medical centres in France who had preoperative haemoglobin concentrations between 9·5 and 13·0 g/dL. We randomly allocated participants (1:1:1:1), via a secure web-based service, to ferric derisomaltose (20 mg/kg intravenously) and tranexamic acid (1 g bolus followed by 1 g over 8 h intravenously at inclusion and 3 g topically during surgery), iron plus placebo (normal saline), tranexamic acid plus placebo, or double placebo. Unmasked nurses administered study drugs; participants and other clinical and research staff remained masked to treatment allocation. The primary outcome was the percentage of patients transfused during hospitalisation (or by day 30). The primary analysis included all randomised patients. This study is registered on ClinicalTrials.gov (NCT02972294) and is closed to new participants.
Of 413 patients (51–104 years old, median [IQR] 86 [78–91], 312 [76%] women, 101 [24%] men), 104 received iron plus tranexamic acid, 103 iron plus placebo, 103 tranexamic acid plus placebo, and 103 double placebo between March 31, 2017 and June 18, 2021 (study stopped early for efficacy after the planned interim analysis done on the first 390 patients included on May 25, 2021). Data for the primary outcome were available for all participants. Among patients on double placebo, 31 (30%) were transfused versus 16 (15%) on both drugs (relative risk 0·51 [98·3% CI 0·27−0·97]; p=0·012). 27 (26%) participants on iron (0·81 [0·50−1·29]; p=0·28) and 28 (27%) on tranexamic acid (0·85 [0·54−1·33]; p=0·39) were transfused. 487 adverse events were reported with similar event rates among the groups; among prespecified safety endpoints, severe postoperative anaemia (haemoglobin <8 g/dL) was more frequent in the double placebo group. Main common adverse event were sepsis, pneumonia, and urinary infection, with similar rates among all groups.
In patients hospitalised for hip fracture surgery with a haemoglobin concentration 9·5–13·0 g/dL, preoperative infusion of ferric derisomaltose plus tranexamic acid reduced the risk of blood transfusion by 50%. Our results suggest that combining treatments from two different pillars improves patient blood-management programmes. Either treatment alone did not reduce transfusion rates, but we might not have had the power to detect it.
French Ministry of Health, HiFIT trial.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Anemia / drug therapy</subject><subject>Anemia / etiology</subject><subject>Blood Transfusion</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Hemoglobins</subject><subject>Hip Fractures / chemically induced</subject><subject>Hip Fractures / drug therapy</subject><subject>Hip Fractures / surgery</subject><subject>Human health and pathology</subject><subject>Humans</subject><subject>Iron / therapeutic use</subject><subject>Life Sciences</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Tranexamic Acid / adverse effects</subject><subject>Tranexamic Acid / therapeutic use</subject><subject>Treatment Outcome</subject><issn>2352-3026</issn><issn>2352-3026</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><recordid>eNqFUs2O0zAQjhCIXS37CCAfW6kB_yVNuKDVitKVKnFgOVv-mVAjJy62s8CNK0_AA_EanHgSnGapuHGxR-PvZzwzRfGU4OcEk_rFO8oqWjJM6wVlS5xTrCQPivNT-uE_8VlxGeNHnFFsXVd1-7g4Y-uK8qx0XvzaQAhWIwPBRt9Ll3wEJAeDUpADfJF9fpTamhXSvld2AIN8QNL5AVaoy2EAM2o7fEDKeT_TYjdG6wdkB3SQycKQIvps0x7t7QF1Qeo0BkCLtAe0tZub20yy0i1fIon60SWrMyNkefr72_efP_JBUZdJfkKtUDYwvrcRck3Gj8pBqZwdjhVmnncOzKz4pHjUSRfh8v6-KN5vXt9eb8vd2zc311e7UjPCU0mkYrQD0Gul2rapjFrzdU2g6SpFOW95zSWQuma0bgg2VWdaUB01Kje3khizi2I56-6lE4dgexm-Ci-t2F7txJTDvKGY0eqOZOxixh6C_zRCTCJ_RYNzudt-jII2nNcN5phlaDVDdfAxBuhO2gSLaQ_EcQ_ENGRBmTjugZgsnt1bjKoHc2L9nXoGvJoBkJtyZyGIqPOUNBgbQCdhvP2PxR8racaF</recordid><startdate>20230901</startdate><enddate>20230901</enddate><creator>Lasocki, Sigismond</creator><creator>Capdevila, Xavier</creator><creator>Vielle, Bruno</creator><creator>Bijok, Benjamin</creator><creator>Lahlou-Casulli, Maria</creator><creator>Collange, Vincent</creator><creator>Grillot, Nicolas</creator><creator>Danguy des Deserts, Marc</creator><creator>Duchalais, Alexis</creator><creator>Delannoy, Bertrand</creator><creator>Drugeon, Bertrand</creator><creator>Bouzat, Pierre</creator><creator>David, Jean-Stéphane</creator><creator>Rony, Louis</creator><creator>Loupec, Thibault</creator><creator>Léger, Maxime</creator><creator>Rineau, Emmanuel</creator><creator>Bouhours, Guillaume</creator><creator>Lasocki, Sigismond</creator><creator>Lebail, Adeline</creator><creator>Léger, Maxime</creator><creator>Parot-Schinkel, Elsa</creator><creator>Rineau, Emmanuel</creator><creator>Rony, Louis</creator><creator>Vielle, Bruno</creator><creator>Capdevilla, Xavier</creator><creator>Loupec, Thibault</creator><creator>Mounet, Benjamin</creator><creator>Swisser, Fabien</creator><creator>Danguy des Deserts, Marc</creator><creator>Cinotti, Raphael</creator><creator>Grillot, Nicolas</creator><creator>Asehnoune, Karim</creator><creator>Roquilly, Antoine</creator><creator>Beloeil, Hélène</creator><creator>Lahlou-Casulli, Maria</creator><creator>Collange, Vincent</creator><creator>Parent, Sébastien</creator><creator>Delannoy, Bertrand</creator><creator>Desebbe, Olivier</creator><creator>Duchalais, Alexis</creator><creator>Drugeon, Bertrand</creator><creator>Guenezan, Jeremy</creator><creator>Bouzat, Pierre</creator><creator>Drevet, Sabine</creator><creator>Gavazzi, Gaetan</creator><creator>Greze, Jules</creator><creator>Bijok, Benjamin</creator><creator>Garrigue, Delphine</creator><creator>David, Jean-Stéphane</creator><general>Elsevier Ltd</general><general>Elsevier</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>1XC</scope><orcidid>https://orcid.org/0000-0001-9217-8532</orcidid><orcidid>https://orcid.org/0000-0002-5447-6595</orcidid><orcidid>https://orcid.org/0000-0003-1026-7975</orcidid></search><sort><creationdate>20230901</creationdate><title>Ferric derisomaltose and tranexamic acid, combined or alone, for reducing blood transfusion in patients with hip fracture (the HiFIT trial): a multicentre, 2 × 2 factorial, randomised, double-blind, controlled trial</title><author>Lasocki, Sigismond ; Capdevila, Xavier ; Vielle, Bruno ; Bijok, Benjamin ; Lahlou-Casulli, Maria ; Collange, Vincent ; Grillot, Nicolas ; Danguy des Deserts, Marc ; Duchalais, Alexis ; Delannoy, Bertrand ; Drugeon, Bertrand ; Bouzat, Pierre ; David, Jean-Stéphane ; Rony, Louis ; Loupec, Thibault ; Léger, Maxime ; Rineau, Emmanuel ; Bouhours, Guillaume ; Lasocki, Sigismond ; Lebail, Adeline ; Léger, Maxime ; Parot-Schinkel, Elsa ; Rineau, Emmanuel ; Rony, Louis ; Vielle, Bruno ; Capdevilla, Xavier ; Loupec, Thibault ; Mounet, Benjamin ; Swisser, Fabien ; Danguy des Deserts, Marc ; Cinotti, Raphael ; Grillot, Nicolas ; Asehnoune, Karim ; Roquilly, Antoine ; Beloeil, Hélène ; Lahlou-Casulli, Maria ; Collange, Vincent ; Parent, Sébastien ; Delannoy, Bertrand ; Desebbe, Olivier ; Duchalais, Alexis ; Drugeon, Bertrand ; Guenezan, Jeremy ; Bouzat, Pierre ; Drevet, Sabine ; Gavazzi, Gaetan ; Greze, Jules ; Bijok, Benjamin ; Garrigue, Delphine ; David, Jean-Stéphane</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c314t-1ab32feec7bb9985db74761e8f5b2449464ae166326810d5fd9ebf2db0265a003</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Anemia / drug therapy</topic><topic>Anemia / etiology</topic><topic>Blood Transfusion</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Hemoglobins</topic><topic>Hip Fractures / chemically induced</topic><topic>Hip Fractures / drug therapy</topic><topic>Hip Fractures / surgery</topic><topic>Human health and pathology</topic><topic>Humans</topic><topic>Iron / therapeutic use</topic><topic>Life Sciences</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Tranexamic Acid / adverse effects</topic><topic>Tranexamic Acid / therapeutic use</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Lasocki, Sigismond</creatorcontrib><creatorcontrib>Capdevila, Xavier</creatorcontrib><creatorcontrib>Vielle, Bruno</creatorcontrib><creatorcontrib>Bijok, Benjamin</creatorcontrib><creatorcontrib>Lahlou-Casulli, Maria</creatorcontrib><creatorcontrib>Collange, Vincent</creatorcontrib><creatorcontrib>Grillot, Nicolas</creatorcontrib><creatorcontrib>Danguy des Deserts, Marc</creatorcontrib><creatorcontrib>Duchalais, Alexis</creatorcontrib><creatorcontrib>Delannoy, Bertrand</creatorcontrib><creatorcontrib>Drugeon, Bertrand</creatorcontrib><creatorcontrib>Bouzat, Pierre</creatorcontrib><creatorcontrib>David, Jean-Stéphane</creatorcontrib><creatorcontrib>Rony, Louis</creatorcontrib><creatorcontrib>Loupec, Thibault</creatorcontrib><creatorcontrib>Léger, Maxime</creatorcontrib><creatorcontrib>Rineau, Emmanuel</creatorcontrib><creatorcontrib>Bouhours, Guillaume</creatorcontrib><creatorcontrib>Lasocki, Sigismond</creatorcontrib><creatorcontrib>Lebail, Adeline</creatorcontrib><creatorcontrib>Léger, Maxime</creatorcontrib><creatorcontrib>Parot-Schinkel, Elsa</creatorcontrib><creatorcontrib>Rineau, Emmanuel</creatorcontrib><creatorcontrib>Rony, Louis</creatorcontrib><creatorcontrib>Vielle, Bruno</creatorcontrib><creatorcontrib>Capdevilla, Xavier</creatorcontrib><creatorcontrib>Loupec, Thibault</creatorcontrib><creatorcontrib>Mounet, Benjamin</creatorcontrib><creatorcontrib>Swisser, Fabien</creatorcontrib><creatorcontrib>Danguy des Deserts, Marc</creatorcontrib><creatorcontrib>Cinotti, Raphael</creatorcontrib><creatorcontrib>Grillot, Nicolas</creatorcontrib><creatorcontrib>Asehnoune, Karim</creatorcontrib><creatorcontrib>Roquilly, Antoine</creatorcontrib><creatorcontrib>Beloeil, Hélène</creatorcontrib><creatorcontrib>Lahlou-Casulli, Maria</creatorcontrib><creatorcontrib>Collange, Vincent</creatorcontrib><creatorcontrib>Parent, Sébastien</creatorcontrib><creatorcontrib>Delannoy, Bertrand</creatorcontrib><creatorcontrib>Desebbe, Olivier</creatorcontrib><creatorcontrib>Duchalais, Alexis</creatorcontrib><creatorcontrib>Drugeon, Bertrand</creatorcontrib><creatorcontrib>Guenezan, Jeremy</creatorcontrib><creatorcontrib>Bouzat, Pierre</creatorcontrib><creatorcontrib>Drevet, Sabine</creatorcontrib><creatorcontrib>Gavazzi, Gaetan</creatorcontrib><creatorcontrib>Greze, Jules</creatorcontrib><creatorcontrib>Bijok, Benjamin</creatorcontrib><creatorcontrib>Garrigue, Delphine</creatorcontrib><creatorcontrib>David, Jean-Stéphane</creatorcontrib><creatorcontrib>HiFIT Investigators</creatorcontrib><creatorcontrib>SFAR research network</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>Hyper Article en Ligne (HAL)</collection><jtitle>The Lancet. Haematology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Lasocki, Sigismond</au><au>Capdevila, Xavier</au><au>Vielle, Bruno</au><au>Bijok, Benjamin</au><au>Lahlou-Casulli, Maria</au><au>Collange, Vincent</au><au>Grillot, Nicolas</au><au>Danguy des Deserts, Marc</au><au>Duchalais, Alexis</au><au>Delannoy, Bertrand</au><au>Drugeon, Bertrand</au><au>Bouzat, Pierre</au><au>David, Jean-Stéphane</au><au>Rony, Louis</au><au>Loupec, Thibault</au><au>Léger, Maxime</au><au>Rineau, Emmanuel</au><au>Bouhours, Guillaume</au><au>Lasocki, Sigismond</au><au>Lebail, Adeline</au><au>Léger, Maxime</au><au>Parot-Schinkel, Elsa</au><au>Rineau, Emmanuel</au><au>Rony, Louis</au><au>Vielle, Bruno</au><au>Capdevilla, Xavier</au><au>Loupec, Thibault</au><au>Mounet, Benjamin</au><au>Swisser, Fabien</au><au>Danguy des Deserts, Marc</au><au>Cinotti, Raphael</au><au>Grillot, Nicolas</au><au>Asehnoune, Karim</au><au>Roquilly, Antoine</au><au>Beloeil, Hélène</au><au>Lahlou-Casulli, Maria</au><au>Collange, Vincent</au><au>Parent, Sébastien</au><au>Delannoy, Bertrand</au><au>Desebbe, Olivier</au><au>Duchalais, Alexis</au><au>Drugeon, Bertrand</au><au>Guenezan, Jeremy</au><au>Bouzat, Pierre</au><au>Drevet, Sabine</au><au>Gavazzi, Gaetan</au><au>Greze, Jules</au><au>Bijok, Benjamin</au><au>Garrigue, Delphine</au><au>David, Jean-Stéphane</au><aucorp>HiFIT Investigators</aucorp><aucorp>SFAR research network</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Ferric derisomaltose and tranexamic acid, combined or alone, for reducing blood transfusion in patients with hip fracture (the HiFIT trial): a multicentre, 2 × 2 factorial, randomised, double-blind, controlled trial</atitle><jtitle>The Lancet. Haematology</jtitle><addtitle>Lancet Haematol</addtitle><date>2023-09-01</date><risdate>2023</risdate><volume>10</volume><issue>9</issue><spage>e747</spage><epage>e755</epage><pages>e747-e755</pages><issn>2352-3026</issn><eissn>2352-3026</eissn><abstract>Anaemia and blood transfusion are associated with poor outcomes after hip fracture. We evaluated the efficacy of intravenous iron and tranexamic acid in reducing blood transfusions after hip fracture surgery.
In this double-blind, randomised, 2 × 2 factorial trial, we recruited adults hospitalised for hip fractures in 12 medical centres in France who had preoperative haemoglobin concentrations between 9·5 and 13·0 g/dL. We randomly allocated participants (1:1:1:1), via a secure web-based service, to ferric derisomaltose (20 mg/kg intravenously) and tranexamic acid (1 g bolus followed by 1 g over 8 h intravenously at inclusion and 3 g topically during surgery), iron plus placebo (normal saline), tranexamic acid plus placebo, or double placebo. Unmasked nurses administered study drugs; participants and other clinical and research staff remained masked to treatment allocation. The primary outcome was the percentage of patients transfused during hospitalisation (or by day 30). The primary analysis included all randomised patients. This study is registered on ClinicalTrials.gov (NCT02972294) and is closed to new participants.
Of 413 patients (51–104 years old, median [IQR] 86 [78–91], 312 [76%] women, 101 [24%] men), 104 received iron plus tranexamic acid, 103 iron plus placebo, 103 tranexamic acid plus placebo, and 103 double placebo between March 31, 2017 and June 18, 2021 (study stopped early for efficacy after the planned interim analysis done on the first 390 patients included on May 25, 2021). Data for the primary outcome were available for all participants. Among patients on double placebo, 31 (30%) were transfused versus 16 (15%) on both drugs (relative risk 0·51 [98·3% CI 0·27−0·97]; p=0·012). 27 (26%) participants on iron (0·81 [0·50−1·29]; p=0·28) and 28 (27%) on tranexamic acid (0·85 [0·54−1·33]; p=0·39) were transfused. 487 adverse events were reported with similar event rates among the groups; among prespecified safety endpoints, severe postoperative anaemia (haemoglobin <8 g/dL) was more frequent in the double placebo group. Main common adverse event were sepsis, pneumonia, and urinary infection, with similar rates among all groups.
In patients hospitalised for hip fracture surgery with a haemoglobin concentration 9·5–13·0 g/dL, preoperative infusion of ferric derisomaltose plus tranexamic acid reduced the risk of blood transfusion by 50%. Our results suggest that combining treatments from two different pillars improves patient blood-management programmes. Either treatment alone did not reduce transfusion rates, but we might not have had the power to detect it.
French Ministry of Health, HiFIT trial.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>37524101</pmid><doi>10.1016/S2352-3026(23)00163-1</doi><orcidid>https://orcid.org/0000-0001-9217-8532</orcidid><orcidid>https://orcid.org/0000-0002-5447-6595</orcidid><orcidid>https://orcid.org/0000-0003-1026-7975</orcidid></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 2352-3026 |
| ispartof | The Lancet. Haematology, 2023-09, Vol.10 (9), p.e747-e755 |
| issn | 2352-3026 2352-3026 |
| language | eng |
| recordid | cdi_hal_primary_oai_HAL_hal_04820325v1 |
| source | Alma/SFX Local Collection |
| subjects | Adult Aged Aged, 80 and over Anemia / drug therapy Anemia / etiology Blood Transfusion Double-Blind Method Female Hemoglobins Hip Fractures / chemically induced Hip Fractures / drug therapy Hip Fractures / surgery Human health and pathology Humans Iron / therapeutic use Life Sciences Male Middle Aged Tranexamic Acid / adverse effects Tranexamic Acid / therapeutic use Treatment Outcome |
| title | Ferric derisomaltose and tranexamic acid, combined or alone, for reducing blood transfusion in patients with hip fracture (the HiFIT trial): a multicentre, 2 × 2 factorial, randomised, double-blind, controlled trial |
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