Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2025-12-29 @ 12:24 PM
Study NCT ID:
NCT03545750
Status:
UNKNOWN
Last Update Posted:
2019-11-25
First Post:
2018-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Renal Replacement Anticoagulant Management
Sponsor:
Intensive Care National Audit & Research Centre
Organization:
Study Overview
Official Title:
Renal Replacement Anticoagulant Management
Status:
UNKNOWN
Status Verified Date:
2019-11
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
RRAM
Brief Summary:
Observational comparative effectiveness study of individual patient data using interrupted time series analysis techniques of linked data sources to establish clinical and health economic effects of moving from systemic heparin anticoagulation to regional citrate anticoagulation during continuous renal replacement therapy (CRRT) for patients treated on non-specialist Intensive Care Units (ICUs) in England and Wales.
Detailed Description:
RRAM is an observational comparative effectiveness and cost-effectiveness study of individual patient data using interrupted time series analysis techniques and linked data sources. This study will use existing high quality clinical data collected for the Case Mix programme (CMP) - the national clinical audit for adult critical care - linked with Hospital Episodes Statistics, Office for National Statistics, and UK Renal Registry national data sets to establish the clinical and health economic effects of moving from systemic heparin anticoagulation (SHA) to regional citrate anticoagulation (RCA) during CRRT for patients treated on non-specialist ICUs in England and Wales. This will include data from approximately 85,000 patients treated with CRRT between 1 April 2009 and 31 March 2017 in 184 English non-specialist intensive care units within the ICNARC CMP.
Specific objectives of the RRAM are to:
1. Investigate the short-term benefits, risks, and costs of citrate anticoagulation.
2. Provide information on the subsequent development of end-stage renal disease (ESRD).
3. Trial the efficient research techniques, that if successful could be used to track the effects of any change in critical care practice occurring in ICUs in England and Wales over a reasonably short time scale.
Specific objectives of the RRAM are to:
1. Investigate the short-term benefits, risks, and costs of citrate anticoagulation.
2. Provide information on the subsequent development of end-stage renal disease (ESRD).
3. Trial the efficient research techniques, that if successful could be used to track the effects of any change in critical care practice occurring in ICUs in England and Wales over a reasonably short time scale.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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?: