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OpenTrials
Completed

NCT Number: NCT01264458

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.

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Key information

Conditions

Venothromboembolism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Dec 21, 2010
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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