Multicenter Registry for Comparative Effectiveness Analysis of Venous Thromboembolism in Trauma Patients (CLOTT)
Venous thromboembolism (VTE) remains a leading cause of death in trauma patients. Based on the EAST Management Guidelines for the prevention of VTE in trauma patients, a number of research questions could be addressed by a thorough current literature review combined with a multicenter concurrent analysis. This proposal seeks to create a data registry of trauma patients from multiple trauma centers around the United States that will serve as a platform for the study of VTE.
Deep Vein Thrombosis
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration:||30 Days|
|Official Title:||Consortium of Leaders in the Study Of Traumatic Thromboembolism (CLOTT): A Multicenter Registry for Determining the Comparative Effectiveness of Risk Assessment, Prophylaxis, Surveillance, and Treatment of Venous Thromboembolism in Trauma Patients|
- Venous Thromboembolism (VTE) [ Time Frame: 30 Days from time of hospital admission ] [ Designated as safety issue: Yes ]VTE is the clinical spectrum of disease including Deep Vein Thrombosis (DVT) and Pulmonary Embolus.
- Complications following VTE care [ Time Frame: 30 days from date of hospital addmission ] [ Designated as safety issue: Yes ]The standard prophylaxis of, and care for diagnosed VTE disease in trauma patients involves medications and devices which themselves have inherent risk. These risks/possible complications include: Death, bleeding, heparin induced thrombocytopenia, and complications associated with the insertion or removal of inferior vena caval filters.
|Study Start Date:||August 2013|
|Estimated Study Completion Date:||October 2016|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
Trauma patients at moderate to highest risk for VTE
Patients admitted to the hospital for care of traumatic injuries who have from a moderate to highest level of VTE risk. These risk levels are assessed within the first 24 hours following hospital admission as mandated by the Surgical Quality Improvement Project (SCIP) Guidelines. Individual risk level will be assessed and determined according to each individual reporting institution's risk assessment protocol. This will be a prospective registry of trauma patients without any study based interventions.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01890044
|United States, California|
|Scripps Mercy Hospital|
|San Diego, California, United States, 92103|
|Principal Investigator:||Steven R Shackford, MD||Scripps Health|