NCT02418923

Brief Summary

This study compares the results of current standard coagulation measurement devices to the Quantra System, a new device, using small amount of extra blood obtained during routine blood draws in neurosurgery patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 17, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

May 11, 2016

Status Verified

May 1, 2016

Enrollment Period

4 months

First QC Date

April 13, 2015

Last Update Submit

May 10, 2016

Conditions

Deformity of Spine

Outcome Measures

Primary Outcomes (2)

  • assay inter-instrument variability

    Demonstrate assay inter-instrument variability below 15%

    1 day

  • Establish normal ranges

    Establish normal ranges

    1 day

Interventions

Procedure: Blood specimen collectionOTHER

Blood specimen collection

Eligibility Criteria

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

Participants for this study will be recruited at the University of Virginia Medical Center. The subject population will be representative of the local racial and ethnic population.

You may qualify if:

  • Subject is scheduled for major deformity correction spine surgery
  • Subject is older than 18 years
  • Subject is willing to participate and he/she has signed a consent form

You may not qualify if:

  • Subject is unable to provide written informed consent
  • Subject is incarcerated at the time of the study
  • Subject is affected by any condition that, in the opinion of the surgical team, may pose additional risks
  • Subjects with renal disease (defined as serum creatinine greater than 1.5 mg/dl)
  • Subjects with history of active liver disease
  • Subjects affected by Factor V Leiden mutation
  • Subjects affected by von Willebrand disease
  • Subjects with an history of thrombotic disease (more than one DVT)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Study Officials

  • Bhiken Naik, MD

    UVA Anethesiology Faculty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
UVA Anesthesiology Faculty

Study Record Dates

First Submitted

April 13, 2015

First Posted

April 17, 2015

Study Start

April 1, 2015

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

May 11, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)