NCT01448694

Brief Summary

This study is part of a Phase II STTR project to develop an algorithm called CipherSensor to apply feature extraction and machine learning techniques to non-invasive hemodynamic data to identify early signs of acute blood loss. The availability of this information may help to establish required interventions for treating trauma patients and battlefield casualties. Study hypothesis: Hemodynamic changes measured non-invasively during the blood donation process can be modeled to provide early estimations of blood loss.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
320

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2011

Typical duration 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

First Submitted

Initial submission to the registry

October 5, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 7, 2011

Completed
25 days until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

December 3, 2014

Status Verified

December 1, 2014

Enrollment Period

1.9 years

First QC Date

October 5, 2011

Last Update Submit

December 1, 2014

Conditions

Hemorrhage

Keywords

Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • Algorithm

    Mathematical model of early blood loss

    24 months

Study Arms (1)

Blood donors

Healthy volunteers who are donating a pint of whole blood

Other: No treatment

Interventions

No treatmentOTHER

No treatment, only collecting observational data.

Blood donors

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy adults

You may qualify if:

  • Approved by Children's Hospital Colorado Blood Donation Center for blood donation
  • Age 18 -89 years
  • Previously donated blood (lower likelihood of vasovagal response)

You may not qualify if:

  • Pregnant
  • Incarcerated
  • Limited access to or compromised monitoring sites for non-invasive sensors: finger, ear and forehead sensors, oral/nasal cannula, 3 ECG electrodes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Steve Moulton, MD

    Children's Hospital Colorado

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2011

First Posted

October 7, 2011

Study Start

November 1, 2011

Primary Completion

October 1, 2013

Study Completion

September 1, 2014

Last Updated

December 3, 2014

Record last verified: 2014-12

Locations

US(1)