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
  Purpose

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
Venothromboembolism

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Microvesicle Production After Acute Trauma and Its Clinical Impact on Venothromboembolism

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 2720
Study Start Date: January 2011
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Traumatic Injury
Trauma patients arriving at Saint Mary's Emergency Department
Control group

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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: NCT01264458

Contacts
Contact: Myung Park, M.D. (507) 255-6960 park.myung@mayo.edu

Locations
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Melissa Kuntz    507-293-1239    kuntz.melissa@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Myung Park, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Myung S. Park, Assistant Professor of Surgery, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01264458     History of Changes
Other Study ID Numbers: 10-001889
Study First Received: December 20, 2010
Last Updated: October 4, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 23, 2014