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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Lancaster General Hospital
University of Florida
Medical University of South Carolina
Portland VA Medical Center
Stanford University
Johns Hopkins University
Massachusetts General Hospital
The University of Texas Health Science Center, Houston
Medical College of Wisconsin
Oregon Health and Science University
Christiana Care Health Services
San Francisco General Hospital
University of Utah
Carolinas Medical Center
Information provided by (Responsible Party):
Scripps Health
ClinicalTrials.gov Identifier:
NCT01890044
First received: June 26, 2013
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

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.


Condition
Venous Thromboembolism
Pulmonary Embolus
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

Resource links provided by NLM:


Further study details as provided by Scripps Health:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 10000
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)
Groups/Cohorts
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Discharged prior to 24 hours in hospital
  • Minimal VTE risk
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01890044

Locations
United States, California
Scripps Mercy Hospital
San Diego, California, United States, 92103
Sponsors and Collaborators
Scripps Health
Lancaster General Hospital
University of Florida
Medical University of South Carolina
Portland VA Medical Center
Stanford University
Johns Hopkins University
Massachusetts General Hospital
The University of Texas Health Science Center, Houston
Medical College of Wisconsin
Oregon Health and Science University
Christiana Care Health Services
San Francisco General Hospital
University of Utah
Carolinas Medical Center
Investigators
Principal Investigator: Steven R Shackford, MD Scripps Health
  More Information

No publications provided

Responsible Party: Scripps Health
ClinicalTrials.gov Identifier: NCT01890044     History of Changes
Other Study ID Numbers: IRB-11-5786
Study First Received: June 26, 2013
Last Updated: February 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Scripps Health:
VTE
DVT
Venous Thromboembolism
Deep Vein Thrombosis
Pulmonary embolus
Trauma

Additional relevant MeSH terms:
Pulmonary Embolism
Thromboembolism
Thrombosis
Venous Thrombosis
Embolism
Venous Thromboembolism
Lung Diseases
Respiratory Tract Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 24, 2014