NCT01567371

Brief Summary

This is a study to validate the utility and accuracy of the non-invasive device (LiDCOrapid monitor) during a period of phlebotomy and graded blood loss in patients who are having cardiac surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable

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

March 1, 2012

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

March 26, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 30, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 15, 2016

Completed
Last Updated

April 15, 2016

Status Verified

March 1, 2016

Enrollment Period

2.8 years

First QC Date

March 26, 2012

Results QC Date

March 16, 2016

Last Update Submit

March 16, 2016

Conditions

Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

  • Difference in Pulse Pressure Variability From Baseline to Post-ANH

    The difference in pulse pressure variability during a period of phlebotomy and graded blood loss, measured before phlebotomy or acute normovolemic hemodilution (ANH) and immediately after.

    1 Day

Secondary Outcomes (1)

  • Difference in Stroke Volume Variability From Baseline to Post ANH.

    1 Day

Study Arms (1)

LiDCO rapid monitor

EXPERIMENTAL
Device: LiDCO rapid monitor

Interventions

LiDCO rapid monitorDEVICE

Technology which provides a continuous means of monitoring various hemodynamic parameters including cardiac output and pulse pressure variability.

LiDCO rapid monitor

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for intraoperative phlebotomy following anesthetic induction to obtain autologous blood for use following cardiopulmonary bypass and cardiac surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Results Point of Contact

Title
Joseph D. Tobias, MD
Organization
Nationwide Children's Hospital
Joseph.Tobias@nationwidechildrens.org
614-722-4200

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman, Dept. of Anesthesiology & Pain Medicine

Study Record Dates

First Submitted

March 26, 2012

First Posted

March 30, 2012

Study Start

March 1, 2012

Primary Completion

December 1, 2014

Study Completion

March 1, 2015

Last Updated

April 15, 2016

Results First Posted

April 15, 2016

Record last verified: 2016-03

Locations

US(1)