This trial is active, not recruiting.

Condition venothromboembolism
Sponsor Mayo Clinic
Start date January 2011
End date January 2017
Trial size 2720 participants
Trial identifier NCT01264458, 10-001889


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Trauma patients arriving at Saint Mary's Emergency Department

Primary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Microvesicle Production After Acute Trauma and Its Clinical Impact on Venothromboembolism
Principal investigator Myung Park, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Mayo Clinic.