Ignite Creation Date:
2024-05-06 @ 4:14 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04924322
Status:
RECRUITING
Last Update Posted:
2023-11-21
First Post:
2021-06-07
Brief Title:
Catheter-Related Early Thromboprophylaxis With Enoxaparin Studies
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Age-dependent Heterogeneity in the Efficacy of Prophylaxis With Enoxaparin Against Catheter-associated Thrombosis in Critically Ill Children
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CRETE
Brief Summary:
The goal of the CRETE Studies is to investigate the newly identified age-dependent heterogeneity in the efficacy of enoxaparin in reducing the risk of central venous catheter-associated deep venous thrombosis in critically ill children
Detailed Description:
Pediatric venous thromboembolism VTE which is predominantly deep venous thrombosis DVT is a top contributor to harm in hospitalized children Its incidence increased by 300 in the past 2 decades Critical illness and central venous catheter CVC are the most important risk factors for VTE in children Among critically ill children the risk of CVC-associated DVT CADVT is as high as 54 with 72 of cases in infants 1-year old Pharmacologic prophylaxis is the most effective strategy against VTE in adults However due to paucity of age-appropriate evidence on its efficacy against CADVT pharmacologic prophylaxis is uncommon in children Extrapolation of evidence from adults is not appropriate because the hemostatic system changes significantly with age The investigators recently completed a Bayesian phase 2b randomized clinical trial In this trial the investigators randomized critically ill children to early administration of prophylactic dose of enoxaparin the most commonly used anticoagulant for prophylaxis or usual care Prophylaxis with enoxaparin appeared to reduce the risk of CADVT by half In post hoc analyses reduction was limited to older children 1-17 years old The goal of the CRETE Studies is to investigate this newly identified age-dependent heterogeneity in the efficacy of enoxaparin in reducing the risk of CADVT in critically ill children To achieve this goal the investigators aim 1 to confirm the efficacy and safety of early administration of prophylactic dose of enoxaparin in reducing the risk of CADVT in critically ill older children 2 to determine the efficacy and safety of early administration of therapeutic dose of enoxaparin in reducing the risk of CADVT in critically ill infants and 3 to probe the mechanisms that underly the age-dependent heterogeneity in the efficacy of enoxaparin in reducing the risk of CADVT in critically ill children The investigators will conduct 2 multicenter Bayesian explanatory randomized clinical trials in parallel to address Specific Aims 1 and 2 Depending on age subjects will be randomized to different doses of enoxaparin vs usual care Subjects will be systematically assessed for the development of CADVT using ultrasonography and clinically for bleeding Using plasma obtained from subjects in the 2 trials the investigators will conduct an exploratory mechanistic nested case-control study to address Specific Aim 3 Biomarkers of selected mechanisms underlying CVC-associated thrombus formation particularly thrombin generation will be compared between subjects with and without CADVT The investigators will use Bayesian methods to improve the efficiency in the conduct and analyses of these studies The CRETE Studies will provide high-quality age-appropriate evidence that will inform preventive strategies against CADVT and decrease harm in hospitalized children
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01HD106326-01 | NIH | None | httpsreporternihgovquickSearch1R01HD106326-01 |