Microvesicle Production After Acute Trauma and Its Clinical Impact on Venothromboembolism

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01264458

Enrollment

1234

Registered

2010-12-21

Start date

2011-01-31

Completion date

2014-12-14

Last updated

2021-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venothromboembolism

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

United States

Outcome results