NCT01709786

Brief Summary

This study will evaluate the accuracy of two rapid methods of measuring hemoglobin in patients with suspected hemorrhage. These methods will be compared with standard laboratory measurements.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2012

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

September 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 12, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 18, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

August 9, 2016

Completed
Last Updated

August 9, 2016

Status Verified

May 1, 2016

Enrollment Period

1 year

First QC Date

October 12, 2012

Results QC Date

December 14, 2015

Last Update Submit

June 27, 2016

Conditions

Hemorrhage

Keywords

HemorrhageHemoglobinNon-invasive monitoringMedical device accuracy

Outcome Measures

Primary Outcomes (2)

  • CBC Hemoglobin Measurement Compared to Non-invasive Radical-7 Measurement

    Whenever blood was drawn for laboratory measurement of serum hemoglobin, we used one drop of blood to make point-of-care measurements using the CDC and Radical-7 methods. For purposes of reporting outcomes measures, we took an equally weighted average of measurements on each device (i.e., all measurement occasions on all patients). These are the means reported in the Outcome Measures Data Table.

    n ≥ 1 measurements were taken each day. All measurements (n ≥ 7) from ICU Days 1-7 were used in Bland-Altman analysis, equally weighted.

  • CBC Hemoglobin Measurement Compared to Non-invasive iSTAT Measurement

    When blood was drawn for laboratory measurement of serum hemoglobin, one drop of blood was used to make point of care measurements using the CBC and iSTAT methods. For purposes of reporting outcomes measures, we took an equally weighted average of measurements on each device (i.e., all measurement occasions on all patients). These are the means reported in the Outcome Measures Data Table.

    n ≥ 1 measurements were taken each day. All measurements (n ≥ 7) from ICU Days 1-7 were used in Bland-Altman analysis, equally weighted.

Study Arms (1)

Patients with Suspected Hemorrhage

There is a single group of patients in this study -- those with suspected hemorrhage who satisfy the inclusion and exclusion criteria. The same set of measurements will be take from each patients and those measurements will be compared with one another to determine accuracy.

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to the Surgical Intensive Care Unit of University Hospital, Cincinnati will be eligible for this study if they are at risk of ongoing bleeding and require serial CBC measurements. A patient will not be eligible if he or she is:(1) less than 18 years of age, (2) a prisoner, or if (3) clinicians are unable to take pulse oximetry readings due to injuries, burns, amputations, or related problems.

You may qualify if:

  • admitted to surgical intensive care unit (SICU), and
  • at risk of ongoing bleeding, and
  • requires serial CBC measurements

You may not qualify if:

  • \< 18 years of age, or
  • a prisoner, or
  • unable to have pulse oximetry readings (due to injuries, burns, amputations, or related problems)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Cincinnati, Ohio, 45219, United States

Location

Related Publications (11)

  • van KAMPEN E, ZIJLSTRA WG. Standardization of hemoglobinometry. II. The hemiglobincyanide method. Clin Chim Acta. 1961 Jul;6:538-44. doi: 10.1016/0009-8981(61)90145-0. No abstract available.

    PMID: 14453500BACKGROUND

  • International committee for standardization in haematology. Recommendations for haemoglobinometry in human blood. Br J Haematol. 1967 Apr;13:71-5. doi: 10.1111/j.1365-2141.1967.tb00751.x. No abstract available.

    PMID: 5608692BACKGROUND

  • Gayat E, Aulagnier J, Matthieu E, Boisson M, Fischler M. Non-invasive measurement of hemoglobin: assessment of two different point-of-care technologies. PLoS One. 2012;7(1):e30065. doi: 10.1371/journal.pone.0030065. Epub 2012 Jan 6.

    PMID: 22238693BACKGROUND

  • May JM. Vitamin C transport and its role in the central nervous system. Subcell Biochem. 2012;56:85-103. doi: 10.1007/978-94-007-2199-9_6.

    PMID: 22116696BACKGROUND

  • Butwick AJ, Hilton G, Riley ET, Carvalho B. Non-invasive measurement of hemoglobin during cesarean hysterectomy: a case series. Int J Obstet Anesth. 2011 Jul;20(3):240-5. doi: 10.1016/j.ijoa.2011.03.009. Epub 2011 Jun 2.

    PMID: 21640577BACKGROUND

  • Hahn RG, Li Y, Zdolsek J. Non-invasive monitoring of blood haemoglobin for analysis of fluid volume kinetics. Acta Anaesthesiol Scand. 2010 Nov;54(10):1233-40. doi: 10.1111/j.1399-6576.2010.02321.x.

    PMID: 21039345BACKGROUND

  • Myers D, McGraw M, George M, Mulier K, Beilman G. Tissue hemoglobin index: a non-invasive optical measure of total tissue hemoglobin. Crit Care. 2009;13 Suppl 5(Suppl 5):S2. doi: 10.1186/cc8000. Epub 2009 Nov 30.

    PMID: 19951386BACKGROUND

  • Santora RJ, Moore FA. Monitoring trauma and intensive care unit resuscitation with tissue hemoglobin oxygen saturation. Crit Care. 2009;13 Suppl 5(Suppl 5):S10. doi: 10.1186/cc8008. Epub 2009 Nov 30.

    PMID: 19951382BACKGROUND

  • Lamhaut L, Apriotesei R, Combes X, Lejay M, Carli P, Vivien B. Comparison of the accuracy of noninvasive hemoglobin monitoring by spectrophotometry (SpHb) and HemoCue(R) with automated laboratory hemoglobin measurement. Anesthesiology. 2011 Sep;115(3):548-54. doi: 10.1097/ALN.0b013e3182270c22.

    PMID: 21716091BACKGROUND

  • Applegate RL 2nd, Barr SJ, Collier CE, Rook JL, Mangus DB, Allard MW. Evaluation of pulse cooximetry in patients undergoing abdominal or pelvic surgery. Anesthesiology. 2012 Jan;116(1):65-72. doi: 10.1097/ALN.0b013e31823d774f.

    PMID: 22133758BACKGROUND

  • Tsuei BJ, Hanseman DJ, Blakeman MJ, Blakeman TC, Yang SH, Branson RD, Gerlach TW. Accuracy of noninvasive hemoglobin monitoring in patients at risk for hemorrhage. J Trauma Acute Care Surg. 2014 Sep;77(3 Suppl 2):S134-9. doi: 10.1097/TA.0000000000000326.

    PMID: 25159346DERIVED

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Betty Tsuei, MD
Organization
University of Cincinnati
Betty.Tsuei@uc.edu
513-558-5661

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery

Study Record Dates

First Submitted

October 12, 2012

First Posted

October 18, 2012

Study Start

September 1, 2012

Primary Completion

September 1, 2013

Study Completion

December 1, 2013

Last Updated

August 9, 2016

Results First Posted

August 9, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)