Improved Intraoperative Blood Loss EstimatesEBLNCT01634828
Method for Improved Intraoperative Blood Loss Estimates
An observational study of Improved Intraoperative Blood Loss Estimates, run by University of Utah at 1 site in United States.
Trial summary
The purpose of this study is to develop a mathematical algorithm which the investigators plan to use to more accurately estimate intraoperative blood loss. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Improved Intraoperative Blood Loss Estimates
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Elective surgical patients
Who may be able to join
- All elective surgical patients
Who cannot join
- Age < 18
- Pregnant women
- Prisoners
- Lack of informed consent
- Attending Physician feels enrollment could interfere with optimal patient care
- Patients who did not have a preoperative hemoglobin measured as part of their preoperative work-up
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- Patients whose preoperative hemoglobin fraction is abnormal.
- Patients who will likely require an intraoperative blood transfusion.
- Patients for whom the intraoperative use of the Cell Saver is anticipated.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to develop a mathematical algorithm which the investigators plan to use to more accurately estimate intraoperative blood loss.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Minimal blood loss patients | Not described | |
| Moderate to heavy blood loss patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate of intraoperative blood loss
Measured: duration of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Improved Intraoperative Blood Loss EstimatesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annette Macintyre, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01634828
- Sponsor's protocol ID
- FP00002762
- Other IDs
- 56181
- Acronym
- EBL
- Status last verified
- May 2016
- First submitted
- 2 Jul 2012
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Method for Improved Intraoperative Blood Loss Estimates
- ClinicalTrials.gov ID
- NCT01634828
- Acronym / sponsor ID
- EBL / FP00002762
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 6 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to develop a mathematical algorithm which the investigators plan to use to more accurately estimate intraoperative blood loss.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimal blood loss patients | – | – |
| Moderate to heavy blood loss patients | – | – |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Elective surgical patients
Key inclusion criteria (1 listed)
- All elective surgical patients
Key exclusion criteria (9 listed)
- Age < 18
- Pregnant women
- Prisoners
- Lack of informed consent
- Attending Physician feels enrollment could interfere with optimal patient care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Estimate of intraoperative blood loss
Time frame: duration of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Improved Intraoperative Blood Loss Estimates, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimate of intraoperative blood loss (time frame: duration of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2016.