Multicenter Registry for Comparative Effectiveness Analysis of Venous Thromboembolism in Trauma Patients

NCT01890044 | Withdrawn DMC

• 1 other identifier: IRB-11-5786
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Venous Thromboembolism; Pulmonary Embolus; Deep Vein Thrombosis

Keywords

VTE; DVT; Venous Thromboembolism; Deep Vein Thrombosis; Pulmonary embolus; Trauma

Outcome Measures

Primary Outcomes (1)

• Venous Thromboembolism (VTE)

  VTE is the clinical spectrum of disease including Deep Vein Thrombosis (DVT) and Pulmonary Embolus.

  30 Days from time of hospital admission

Secondary Outcomes (1)

• Complications following VTE care

  30 days from date of hospital addmission

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the hospital for the care of traumatic injuries who have a moderate to highest level of VTE risk.

You may qualify if:

• Admitted to the hospital for care of injuries
• Have a greater than minimal (moderate to highest) level of VTE risk

You may not qualify if:

• Discharged prior to 24 hours in hospital
• Minimal VTE risk

Sponsors & Collaborators

• Scripps Health: lead
• Lancaster General Hospital: collaborator
• University of Florida: collaborator
• Medical University of South Carolina: collaborator
• Portland VA Medical Center: collaborator
• Stanford University: collaborator
• Johns Hopkins University: collaborator
• Massachusetts General Hospital: collaborator
• The University of Texas Health Science Center, Houston: collaborator
• Medical College of Wisconsin: collaborator
• Oregon Health and Science University: collaborator
• Christiana Care Health Services: collaborator
• San Francisco General Hospital: collaborator
• University of Utah: collaborator
• Carolinas Medical Center: collaborator

Study Sites (1)

Scripps Mercy Hospital

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Venous Thromboembolism; Pulmonary Embolism; Venous Thrombosis; Wounds and Injuries

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism; Thrombosis

Study Officials

• Steven R Shackford, MD

  Scripps Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2013
• First Posted: July 1, 2013
• Study Start: August 1, 2013
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: June 22, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)