NCT02408029

Brief Summary

This study is being performed to obtain data about the CORA System when used in a trauma clinical setting. The CORA analyzer is a new device that is currently being tested in trauma clinical applications and is not yet cleared for this purpose by the Food and Drug Administration (FDA) for sale in the United States.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
325

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 3, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

January 27, 2016

Status Verified

January 1, 2016

Enrollment Period

7 months

First QC Date

March 25, 2015

Last Update Submit

January 26, 2016

Conditions

Trauma

Keywords

FocusTesting PerformanceCORA Hemostasis System

Outcome Measures

Primary Outcomes (1)

  • Composite measure: Blood coagulation and hemostasis parameters R (min), C-ACT (min), K (min), Angle (degrees), MA (mm) and LY30 (%) parameters for both TEG 5000 and CORA systems

    1 day, measured at time of trauma treatment; no follow-up

Study Arms (1)

Trauma Patients Group

Patients undergoing treatment for injuries and trauma.

Other: Observational study - no intervention

Interventions

Observational study - no interventionOTHER
Trauma Patients Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients 18 years or over undergoing care for trauma.

You may qualify if:

  • years of age and older
  • Complete patient history including age, race, gender and type of trauma should be documented

You may not qualify if:

  • Patients under the age of 18
  • Native whole blood will not be used in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Indiana School of Medicine South Bend Notre Dame Campus

South Bend, Indiana, 46601, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Charles E Wade, Ph.D.

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

  • Martin A Schreiber, M.D.

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

  • Mark Walsh, M.D.

    Indiana School of Medicine, South Bend Notre Dame Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2015

First Posted

April 3, 2015

Study Start

March 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

January 27, 2016

Record last verified: 2016-01

Locations

US(3)