E Vincent S Faustino, Sarah B Kandil, Matthew K Leroue, Anthony A Sochet, Michele Kong, Jill M Cholette, Marianne E Nellis, Matthew G Pinto, Madhuradhar Chegondi, Michelle Ramirez, Hilary Schreiber, Elizabeth W J Kerris, Christie L Glau, Amanda Kolmar, Teddy M Muisyo, Anjali Sharathkumar, Lee Polikoff, Cicero T Silva, Lauren Ehrlich, Oscar M Navarro, Philip C Spinella, Leslie Raffini, Sarah N Taylor, Tara McPartland, Veronika Shabanova
{"title":"依诺肝素导管相关早期血栓预防疗法（CRETE）研究方案。","authors":"E Vincent S Faustino, Sarah B Kandil, Matthew K Leroue, Anthony A Sochet, Michele Kong, Jill M Cholette, Marianne E Nellis, Matthew G Pinto, Madhuradhar Chegondi, Michelle Ramirez, Hilary Schreiber, Elizabeth W J Kerris, Christie L Glau, Amanda Kolmar, Teddy M Muisyo, Anjali Sharathkumar, Lee Polikoff, Cicero T Silva, Lauren Ehrlich, Oscar M Navarro, Philip C Spinella, Leslie Raffini, Sarah N Taylor, Tara McPartland, Veronika Shabanova","doi":"10.1097/PCC.0000000000003648","DOIUrl":null,"url":null,"abstract":"<p><strong>Objectives: </strong>In post hoc analyses of our previous phase 2b Bayesian randomized clinical trial (RCT), prophylaxis with enoxaparin reduced central venous catheter (CVC)-associated deep venous thrombosis (CADVT) in critically ill older children but not in infants. The goal of the Catheter-Related Early Thromboprophylaxis with Enoxaparin (CRETE) Studies is to investigate this newly identified age-dependent heterogeneity in the efficacy of prophylaxis with enoxaparin against CADVT in critically ill children.</p><p><strong>Design: </strong>Two parallel, multicenter Bayesian superiority explanatory RCTs, that is, phase 3 for older children and phase 2b for infants, and an exploratory mechanistic nested case-control study (Trial Registration ClinicalTrials.gov NCT04924322, June 7, 2021).</p><p><strong>Setting: </strong>At least 15 PICUs across the United States.</p><p><strong>Patients: </strong>Older children 1-17 years old ( n = 90) and infants older than 36 weeks corrected gestational age younger than 1 year old ( n = 168) admitted to the PICU with an untunneled CVC inserted in the prior 24 hours. Subjects with or at high risk of clinically relevant bleeding will be excluded.</p><p><strong>Interventions: </strong>Prophylactic dose of enoxaparin starting at 0.5 mg/kg then adjusted to anti-Xa range of 0.2-0.5 international units (IU)/mL for older children and therapeutic dose of enoxaparin starting at 1.5 mg/kg then adjusted to anti-Xa range of greater than 0.5-1.0 IU/mL or 0.2-0.5 IU/mL for infants while CVC is in situ.</p><p><strong>Measurements and main results: </strong>Randomization is 2:1 to enoxaparin or usual care (no enoxaparin) for older children and 1:1:1 to either of 2 anti-Xa ranges of enoxaparin or usual care for infants. Ultrasonography will be performed after removal of CVC to assess for CADVT. Subjects will be monitored for bleeding. Platelet poor plasma will be analyzed for markers of thrombin generation. Samples from subjects with CADVT will be counter-matched 1:1 to subjects without CADVT from the opposite trial arm. Institutional Review Board approved the \"CRETE Studies\" on July 1, 2021. Enrollment is ongoing with planned completion in July 2025 for older children and July 2026 for infants.</p>","PeriodicalId":19760,"journal":{"name":"Pediatric Critical Care Medicine","volume":" ","pages":""},"PeriodicalIF":4.0000,"publicationDate":"2024-11-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Protocol for the Catheter-Related Early Thromboprophylaxis With Enoxaparin (CRETE) Studies.\",\"authors\":\"E Vincent S Faustino, Sarah B Kandil, Matthew K Leroue, Anthony A Sochet, Michele Kong, Jill M Cholette, Marianne E Nellis, Matthew G Pinto, Madhuradhar Chegondi, Michelle Ramirez, Hilary Schreiber, Elizabeth W J Kerris, Christie L Glau, Amanda Kolmar, Teddy M Muisyo, Anjali Sharathkumar, Lee Polikoff, Cicero T Silva, Lauren Ehrlich, Oscar M Navarro, Philip C Spinella, Leslie Raffini, Sarah N Taylor, Tara McPartland, Veronika Shabanova\",\"doi\":\"10.1097/PCC.0000000000003648\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objectives: </strong>In post hoc analyses of our previous phase 2b Bayesian randomized clinical trial (RCT), prophylaxis with enoxaparin reduced central venous catheter (CVC)-associated deep venous thrombosis (CADVT) in critically ill older children but not in infants. The goal of the Catheter-Related Early Thromboprophylaxis with Enoxaparin (CRETE) Studies is to investigate this newly identified age-dependent heterogeneity in the efficacy of prophylaxis with enoxaparin against CADVT in critically ill children.</p><p><strong>Design: </strong>Two parallel, multicenter Bayesian superiority explanatory RCTs, that is, phase 3 for older children and phase 2b for infants, and an exploratory mechanistic nested case-control study (Trial Registration ClinicalTrials.gov NCT04924322, June 7, 2021).</p><p><strong>Setting: </strong>At least 15 PICUs across the United States.</p><p><strong>Patients: </strong>Older children 1-17 years old ( n = 90) and infants older than 36 weeks corrected gestational age younger than 1 year old ( n = 168) admitted to the PICU with an untunneled CVC inserted in the prior 24 hours. Subjects with or at high risk of clinically relevant bleeding will be excluded.</p><p><strong>Interventions: </strong>Prophylactic dose of enoxaparin starting at 0.5 mg/kg then adjusted to anti-Xa range of 0.2-0.5 international units (IU)/mL for older children and therapeutic dose of enoxaparin starting at 1.5 mg/kg then adjusted to anti-Xa range of greater than 0.5-1.0 IU/mL or 0.2-0.5 IU/mL for infants while CVC is in situ.</p><p><strong>Measurements and main results: </strong>Randomization is 2:1 to enoxaparin or usual care (no enoxaparin) for older children and 1:1:1 to either of 2 anti-Xa ranges of enoxaparin or usual care for infants. Ultrasonography will be performed after removal of CVC to assess for CADVT. Subjects will be monitored for bleeding. Platelet poor plasma will be analyzed for markers of thrombin generation. Samples from subjects with CADVT will be counter-matched 1:1 to subjects without CADVT from the opposite trial arm. Institutional Review Board approved the \\\"CRETE Studies\\\" on July 1, 2021. Enrollment is ongoing with planned completion in July 2025 for older children and July 2026 for infants.</p>\",\"PeriodicalId\":19760,\"journal\":{\"name\":\"Pediatric Critical Care Medicine\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":4.0000,\"publicationDate\":\"2024-11-19\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Pediatric Critical Care Medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1097/PCC.0000000000003648\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CRITICAL CARE MEDICINE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pediatric Critical Care Medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1097/PCC.0000000000003648","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CRITICAL CARE MEDICINE","Score":null,"Total":0}
Protocol for the Catheter-Related Early Thromboprophylaxis With Enoxaparin (CRETE) Studies.
Objectives: In post hoc analyses of our previous phase 2b Bayesian randomized clinical trial (RCT), prophylaxis with enoxaparin reduced central venous catheter (CVC)-associated deep venous thrombosis (CADVT) in critically ill older children but not in infants. The goal of the Catheter-Related Early Thromboprophylaxis with Enoxaparin (CRETE) Studies is to investigate this newly identified age-dependent heterogeneity in the efficacy of prophylaxis with enoxaparin against CADVT in critically ill children.
Design: Two parallel, multicenter Bayesian superiority explanatory RCTs, that is, phase 3 for older children and phase 2b for infants, and an exploratory mechanistic nested case-control study (Trial Registration ClinicalTrials.gov NCT04924322, June 7, 2021).
Setting: At least 15 PICUs across the United States.
Patients: Older children 1-17 years old ( n = 90) and infants older than 36 weeks corrected gestational age younger than 1 year old ( n = 168) admitted to the PICU with an untunneled CVC inserted in the prior 24 hours. Subjects with or at high risk of clinically relevant bleeding will be excluded.
Interventions: Prophylactic dose of enoxaparin starting at 0.5 mg/kg then adjusted to anti-Xa range of 0.2-0.5 international units (IU)/mL for older children and therapeutic dose of enoxaparin starting at 1.5 mg/kg then adjusted to anti-Xa range of greater than 0.5-1.0 IU/mL or 0.2-0.5 IU/mL for infants while CVC is in situ.
Measurements and main results: Randomization is 2:1 to enoxaparin or usual care (no enoxaparin) for older children and 1:1:1 to either of 2 anti-Xa ranges of enoxaparin or usual care for infants. Ultrasonography will be performed after removal of CVC to assess for CADVT. Subjects will be monitored for bleeding. Platelet poor plasma will be analyzed for markers of thrombin generation. Samples from subjects with CADVT will be counter-matched 1:1 to subjects without CADVT from the opposite trial arm. Institutional Review Board approved the "CRETE Studies" on July 1, 2021. Enrollment is ongoing with planned completion in July 2025 for older children and July 2026 for infants.
期刊介绍：
Pediatric Critical Care Medicine is written for the entire critical care team: pediatricians, neonatologists, respiratory therapists, nurses, and others who deal with pediatric patients who are critically ill or injured. International in scope, with editorial board members and contributors from around the world, the Journal includes a full range of scientific content, including clinical articles, scientific investigations, solicited reviews, and abstracts from pediatric critical care meetings. Additionally, the Journal includes abstracts of selected articles published in Chinese, French, Italian, Japanese, Portuguese, and Spanish translations - making news of advances in the field available to pediatric and neonatal intensive care practitioners worldwide.
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