Pedro H Franca Gois, David McIntyre, Sharad Ratanjee, Anita Pelecanos, Carla Scuderi, Chungun L Janoschka, Kara Summers, Haibing Wu, Belinda Elford, Dwarakanathan Ranganathan, Helen G Healy
{"title":"无需全身抗凝的血液透析：评估高出血风险患者五种策略的随机对照试验。","authors":"Pedro H Franca Gois, David McIntyre, Sharad Ratanjee, Anita Pelecanos, Carla Scuderi, Chungun L Janoschka, Kara Summers, Haibing Wu, Belinda Elford, Dwarakanathan Ranganathan, Helen G Healy","doi":"10.3390/medsci12030038","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>There has been growing interest in exploring combined interventions to achieve a more effective heparin-free treatment approach.</p><p><strong>Aim: </strong>to evaluate combination of interventions compared to standard practice (intermittent flushes) to prevent clotting and consequently reduce premature interruptions of hemodialysis.</p><p><strong>Methods: </strong>This open-label randomized controlled trial recruited chronic hemodialysis patients with contra-indication to systemic heparinization. Participants were randomized into one of five groups to receive different strategies of heparin-free hemodialysis treatment for up to three sessions.</p><p><strong>Primary endpoint: </strong>the successful completion of hemodialysis without clotting.</p><p><strong>Secondary outcomes: </strong>the clotting of the air traps assessed by a semi-quantitative scale, online KT/V, and safety of the interventions.</p><p><strong>Results: </strong>Forty participants were recruited and randomized between May and December 2020. Participants showed similar baseline biochemistry results and coagulation profiles. The highest success rates were observed in group 3 (heparin-coated dialyzers combined with intermittent flushes) (100%) and group 5 (hemodiafiltration with online predilution combined with heparin-coated dialyzers), with 91% vs. the control (intermittent flushes) (64%). Group 2 (heparin-coated dialyzers alone) had the poorest success rate, with 38% of the sessions being prematurely terminated due to clotting. KT/V and clotting scores were similar between groups. No adverse events related to the trial interventions were observed.</p><p><strong>Conclusions: </strong>The proposed combination of interventions may have had additive effects, leading to less frequent clotting and the premature termination of an HD/HDF session. Our study supports the feasibility of conducting a larger randomized controlled trial focusing on the efficacy of combined interventions for heparin-free HD in patients with a high risk of bleeding.</p>","PeriodicalId":74152,"journal":{"name":"Medical sciences (Basel, Switzerland)","volume":"12 3","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2024-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11348230/pdf/","citationCount":"0","resultStr":"{\"title\":\"Hemodialysis without Systemic Anticoagulation: A Randomized Controlled Trial to Evaluate Five Strategies in Patients at a High Risk of Bleeding.\",\"authors\":\"Pedro H Franca Gois, David McIntyre, Sharad Ratanjee, Anita Pelecanos, Carla Scuderi, Chungun L Janoschka, Kara Summers, Haibing Wu, Belinda Elford, Dwarakanathan Ranganathan, Helen G Healy\",\"doi\":\"10.3390/medsci12030038\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>There has been growing interest in exploring combined interventions to achieve a more effective heparin-free treatment approach.</p><p><strong>Aim: </strong>to evaluate combination of interventions compared to standard practice (intermittent flushes) to prevent clotting and consequently reduce premature interruptions of hemodialysis.</p><p><strong>Methods: </strong>This open-label randomized controlled trial recruited chronic hemodialysis patients with contra-indication to systemic heparinization. Participants were randomized into one of five groups to receive different strategies of heparin-free hemodialysis treatment for up to three sessions.</p><p><strong>Primary endpoint: </strong>the successful completion of hemodialysis without clotting.</p><p><strong>Secondary outcomes: </strong>the clotting of the air traps assessed by a semi-quantitative scale, online KT/V, and safety of the interventions.</p><p><strong>Results: </strong>Forty participants were recruited and randomized between May and December 2020. Participants showed similar baseline biochemistry results and coagulation profiles. The highest success rates were observed in group 3 (heparin-coated dialyzers combined with intermittent flushes) (100%) and group 5 (hemodiafiltration with online predilution combined with heparin-coated dialyzers), with 91% vs. the control (intermittent flushes) (64%). Group 2 (heparin-coated dialyzers alone) had the poorest success rate, with 38% of the sessions being prematurely terminated due to clotting. KT/V and clotting scores were similar between groups. No adverse events related to the trial interventions were observed.</p><p><strong>Conclusions: </strong>The proposed combination of interventions may have had additive effects, leading to less frequent clotting and the premature termination of an HD/HDF session. Our study supports the feasibility of conducting a larger randomized controlled trial focusing on the efficacy of combined interventions for heparin-free HD in patients with a high risk of bleeding.</p>\",\"PeriodicalId\":74152,\"journal\":{\"name\":\"Medical sciences (Basel, Switzerland)\",\"volume\":\"12 3\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-08-04\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11348230/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Medical sciences (Basel, Switzerland)\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.3390/medsci12030038\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Medical sciences (Basel, Switzerland)","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.3390/medsci12030038","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"Medicine","Score":null,"Total":0}
Hemodialysis without Systemic Anticoagulation: A Randomized Controlled Trial to Evaluate Five Strategies in Patients at a High Risk of Bleeding.
Background: There has been growing interest in exploring combined interventions to achieve a more effective heparin-free treatment approach.
Aim: to evaluate combination of interventions compared to standard practice (intermittent flushes) to prevent clotting and consequently reduce premature interruptions of hemodialysis.
Methods: This open-label randomized controlled trial recruited chronic hemodialysis patients with contra-indication to systemic heparinization. Participants were randomized into one of five groups to receive different strategies of heparin-free hemodialysis treatment for up to three sessions.
Primary endpoint: the successful completion of hemodialysis without clotting.
Secondary outcomes: the clotting of the air traps assessed by a semi-quantitative scale, online KT/V, and safety of the interventions.
Results: Forty participants were recruited and randomized between May and December 2020. Participants showed similar baseline biochemistry results and coagulation profiles. The highest success rates were observed in group 3 (heparin-coated dialyzers combined with intermittent flushes) (100%) and group 5 (hemodiafiltration with online predilution combined with heparin-coated dialyzers), with 91% vs. the control (intermittent flushes) (64%). Group 2 (heparin-coated dialyzers alone) had the poorest success rate, with 38% of the sessions being prematurely terminated due to clotting. KT/V and clotting scores were similar between groups. No adverse events related to the trial interventions were observed.
Conclusions: The proposed combination of interventions may have had additive effects, leading to less frequent clotting and the premature termination of an HD/HDF session. Our study supports the feasibility of conducting a larger randomized controlled trial focusing on the efficacy of combined interventions for heparin-free HD in patients with a high risk of bleeding.
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