Microvesicle Production After Acute Trauma and Its Clinical Impact on Venothromboembolism

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Myung S. Park, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01264458
First received: December 20, 2010
Last updated: October 4, 2014
Last verified: October 2014

December 20, 2010
October 4, 2014
January 2011
January 2016   (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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01264458 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Trauma patients arriving to Saint Mary's Emergency Department and control patients.

Venothromboembolism
Not Provided
  • Traumatic Injury
    Trauma patients arriving at Saint Mary's Emergency Department
  • Control group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2720
Not Provided
January 2016   (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
Both
18 Years and older
Yes
Contact: Myung Park, M.D. (507) 255-6960 park.myung@mayo.edu
United States
 
NCT01264458
10-001889
No
Myung S. Park, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Myung Park, M.D. Mayo Clinic
Mayo Clinic
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP