Microvesicle Production After Acute Trauma and Its Clinical Impact on Venothromboembolism
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Myung S. Park, Mayo Clinic
First received: December 20, 2010
Last updated: May 5, 2015
Last verified: May 2015
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.
||Observational Model: Case Control
Time Perspective: Prospective
||Microvesicle Production After Acute Trauma and Its Clinical Impact on Venothromboembolism
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:
| Study Start Date:
| Estimated Primary Completion Date:
||January 2016 (Final data collection date for primary outcome measure)
Trauma patients arriving at Saint Mary's Emergency Department
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Trauma patients arriving to Saint Mary's Emergency Department and control patients.
- Male and female patients 18 years of age or older
- Blunt trauma patients including those with closed head injury
- Penetrating trauma patients
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01264458
|Mayo Clinic in Rochester
|Rochester, Minnesota, United States, 55905 |
||Myung Park, M.D.
No publications provided
ClinicalTrials.gov processed this record on October 06, 2015
||Myung S. Park, Assistant Professor of Surgery, Mayo Clinic
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 20, 2010
||May 5, 2015
||United States: Institutional Review Board