NCT02421250

Brief Summary

The study is a clinical trial to determine whether more efficient medical and operational outcomes can be achieved with using the new SpHb monitoring during triage in the emergency room setting. The investigators also evaluate the accuracy of the measurements of the SpHb device by Maximo versus the gold standard of central hospital laboratory value. In addition, the investigators will assess patient satisfaction with the tool.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

April 15, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 20, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

August 27, 2018

Status Verified

August 1, 2018

Enrollment Period

1 year

First QC Date

April 15, 2015

Last Update Submit

August 23, 2018

Conditions

Hemoglobin

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin Measurements

    Hemoglobin level to be measured once at triage; hgb measurements (g/dL)

    During intervention period (8 weeks)

Secondary Outcomes (1)

  • Time to procedure

    During intervention period (8 weeks)

Other Outcomes (5)

  • Time to disposition

    During intervention period (8 weeks)

  • Time to blood transfusion

    During intervention period (8 weeks)

  • Hemodynamics

    During intervention period (8 weeks)

  • +2 more other outcomes

Study Arms (2)

Radical-7 Non-invasive Hgb Monitor

EXPERIMENTAL

We use the Radical-7 Noninvasive Hgb Monitor device (provided by Masimo Corporation from Irvine USA) to measure hemoglobin levels in patients in the experimental group.

Device: Radical-7 Noninvasive Hgb Monitor

Control

NO INTERVENTION

We will use standard-of-care for control group and not use the SpHb monitor.

Interventions

Radical-7 Noninvasive Hgb MonitorDEVICE
Radical-7 Non-invasive Hgb Monitor

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • GI bleeding-melena, hematochezia, hematemesis
  • Vaginal bleeding
  • Epistaxis
  • Hematuria
  • Hemoptysis
  • Sickle cell patients
  • Bleeding from recent surgical procedure
  • Dizziness or lightheadedness in LVAD patients or hematology and oncology patients (i.e. cancer, leukemia, lymphoma-currently receiving chemo, stem cell treatment, or bone marrow transplant).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60615, United States

Location

Study Officials

  • Thomas Spiegel, MD MBA

    University of Chicago

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2015

First Posted

April 20, 2015

Study Start

June 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

August 27, 2018

Record last verified: 2018-08

Locations

US(1)