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

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ClinicalTrials.gov Identifier: NCT01890044
Recruitment Status : Withdrawn (Never proceeded with trial. Failure initiate protocol among other centers.)
First Posted : July 1, 2013
Last Update Posted : June 22, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Venous Thromboembolism Pulmonary Embolus Deep Vein Thrombosis

  Show Detailed Description

Study Design

Study Type : Observational [Patient Registry]
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
Official Title: Consortium of Leaders in the Study Of Traumatic Thromboembolism (CLOTT)
Study Start Date : August 2013
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2016
Groups and Cohorts

Group/Cohort
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.


Outcome Measures

Primary Outcome Measures :
  1. Venous Thromboembolism (VTE) [ Time Frame: 30 Days from time of hospital admission ]
    VTE is the clinical spectrum of disease including Deep Vein Thrombosis (DVT) and Pulmonary Embolus.


Secondary Outcome Measures :
  1. Complications following VTE care [ Time Frame: 30 days from date of hospital addmission ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Scripps Health
ClinicalTrials.gov Identifier: NCT01890044     History of Changes
Other Study ID Numbers: IRB-11-5786
First Posted: July 1, 2013    Key Record Dates
Last Update Posted: June 22, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No clinical trial data collected.

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

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