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.

Study Overview

• Status: Completed
• Conditions: Venothromboembolism

• Study Type: Observational
• Enrollment (Actual): 1234

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Estimate the distribution over time of procoagulant Microvesicles (MVs) concentration by cell of origin and endogenous thrombin potential (ETP).	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.	4 years

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Myung Park, M.D., Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (ACTUAL): December 14, 2014
• Study Completion (ACTUAL): December 14, 2014

Study Registration Dates

• First Submitted: December 20, 2010
• First Submitted That Met QC Criteria: December 20, 2010
• First Posted (ESTIMATE): December 21, 2010

Study Record Updates

• Last Update Posted (ACTUAL): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 6, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 10-001889

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No