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Microvesicle Production After Acute Trauma and Its Clinical Impact on Venothromboembolism

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ClinicalTrials.gov Identifier: NCT01264458
Recruitment Status : Active, not recruiting
First Posted : December 21, 2010
Last Update Posted : October 16, 2017
Sponsor:
Information provided by (Responsible Party):
Myung S. Park, Mayo Clinic

Brief Summary:
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.

Condition or disease
Venothromboembolism

Study Type : Observational
Estimated Enrollment : 2720 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Microvesicle Production After Acute Trauma and Its Clinical Impact on Venothromboembolism
Study Start Date : January 2011
Primary Completion Date : January 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Traumatic Injury
Trauma patients arriving at Saint Mary's Emergency Department
Control group



Primary Outcome Measures :
  1. Estimate the distribution over time of procoagulant Microvesicles (MVs) concentration by cell of origin and endogenous thrombin potential (ETP). [ Time Frame: 6 months ]
  2. 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 ]


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:   Yes
Sampling Method:   Probability Sample
Study Population
Trauma patients arriving to Saint Mary's Emergency Department and control patients.
Criteria

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

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): NCT01264458


Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Myung Park, M.D. Mayo Clinic

Responsible Party: Myung S. Park, Assistant Professor of Surgery, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01264458     History of Changes
Other Study ID Numbers: 10-001889
First Posted: December 21, 2010    Key Record Dates
Last Update Posted: October 16, 2017
Last Verified: October 2017