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Method for Improved Intraoperative Blood Loss Estimates (EBL)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01634828
First Posted: July 6, 2012
Last Update Posted: May 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Annette Macintyre, University of Utah
  Purpose
The purpose of this study is to develop a mathematical algorithm which the investigators plan to use to more accurately estimate intraoperative blood loss.

Condition
Improved Intraoperative Blood Loss Estimates

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Method for Improved Intraoperative Blood Loss Estimates

Resource links provided by NLM:


Further study details as provided by Annette Macintyre, University of Utah:

Primary Outcome Measures:
  • Estimate of intraoperative blood loss [ Time Frame: duration of surgery ]

Enrollment: 47
Study Start Date: July 2012
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Minimal blood loss patients
Moderate to heavy blood loss patients

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Elective surgical patients
Criteria

Inclusion Criteria:

All elective surgical patients

Exclusion Criteria:

  1. Age < 18
  2. Pregnant women
  3. Prisoners
  4. Lack of informed consent
  5. Attending Physician feels enrollment could interfere with optimal patient care
  6. Patients who did not have a preoperative hemoglobin measured as part of their preoperative work-up
  7. Patients whose preoperative hemoglobin fraction is abnormal.
  8. Patients who will likely require an intraoperative blood transfusion.
  9. Patients for whom the intraoperative use of the Cell Saver is anticipated.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01634828


Locations
United States, Utah
University of Utah
Salt lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
  More Information

Responsible Party: Annette Macintyre, Principle Investigator, University of Utah
ClinicalTrials.gov Identifier: NCT01634828     History of Changes
Other Study ID Numbers: FP00002762
56181 ( Registry Identifier: IRB University of Utah )
First Submitted: July 2, 2012
First Posted: July 6, 2012
Last Update Posted: May 12, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes