Microvesicle Production After Acute Trauma and Its Clinic... | NCT01264458

Studies
Microvesicle Production After Acute Trauma and Its Clinical Impact on Venothromboembolism

NCT01264458

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Apr 8, 2021Actual

Enrollment

1,234Actual

Phase

Not provided

Conditions

Venothromboembolism

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Dec 14, 2014Actual

Completion Date

Dec 14, 2014Actual

First Submitted Date

Dec 20, 2010

First Submission Date that Met QC Criteria

Dec 20, 2010

First Posted Date

Dec 21, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2021

Last Update Posted Date

Apr 8, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,234Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Traumatic Injury		Trauma patients arriving at Saint Mary's Emergency Department
Control group

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Myung Park, M.D.	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic in Rochester		Rochester	Minnesota	55905	United States

Label	URL
Mayo Clinic Clinical Trials	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided