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Microvesicle Production After Acute Trauma and Its Clinical Impact on Venothromboembolism

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01264458
First Posted: December 21, 2010
Last Update Posted: October 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Myung S. Park, Mayo Clinic
December 20, 2010
December 21, 2010
October 16, 2017
January 2011
January 2017   (Final data collection date for primary outcome measure)
  • Estimate the distribution over time of procoagulant Microvesicles (MVs) concentration by cell of origin and endogenous thrombin potential (ETP). [ Time Frame: 6 months ]
  • Determine the cumulative incidence of Venothromboembolism (VTE) within three months after major trauma and test the distribution of procoagulant MV concentration and endogenous thrombin generation potential over time as potential predictors of VTE. [ Time Frame: 4 years ]
Same as current
Complete list of historical versions of study NCT01264458 on ClinicalTrials.gov Archive Site
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Microvesicle Production After Acute Trauma and Its Clinical Impact on Venothromboembolism
Microvesicle Production After Acute Trauma and Its Clinical Impact on Venothromboembolism
The purpose of this research study is to look at how trauma affects the ability of blood to clot. The blood of people who suffer a traumatic injury can under-clot or over-clot, and this research study will look at blood drawn from people after they suffer a traumatic injury to see how well their blood clots.
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Observational
Observational Model: Case-Control
Time Perspective: Prospective
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Probability Sample
Trauma patients arriving to Saint Mary's Emergency Department and control patients.
Venothromboembolism
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  • Traumatic Injury
    Trauma patients arriving at Saint Mary's Emergency Department
  • Control group
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2720
January 2018
January 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and female patients 18 years of age or older
  • Blunt trauma patients including those with closed head injury
  • Penetrating trauma patients

Exclusion Criteria:

  • Are on therapeutic anticoagulation
  • Have preexisting coagulopathy
  • Patients greater than 12 hours from time of injury
  • Have history of malignancy or preexisting diagnosis of sepsis or renal failure
  • Patients with burn injuries
  • Male and female patients younger than 18 years of age
  • Pregnant patients
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01264458
10-001889
No
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Not Provided
Myung S. Park, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Myung Park, M.D. Mayo Clinic
Mayo Clinic
October 2017