BleedingNCT02138175
Continuous Hemoglobin Monitoring: Detection of Acute Blood Loss - Accurate, Timely and Cost-effective
An observational study of Bleeding and Acute Blood Loss Anemia, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of the study is to determine whether noninvasive hemoglobin monitoring is sensitive and accurate enough to detect a significant downward trend in hemoglobin in patients at risk for significant bleeding. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bleeding, Acute Blood Loss Anemia
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Jan 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult (>18 years) patients admitted to the surgical intensive care unit for hemodynamic monitoring and serial hemoglobin measurements at high risk for bleeding (known solid organ/vascular/orthopedic injury, unexplained hypotension/tachycardia following trauma/surgery, suspected ongoing blood loss-postoperative or gastrointestinal bleeding)
Who may be able to join
- > 18 years of age
- admission to surgical intensive care unit
- suspected or high risk for ongoing blood loss
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Carolinas Medical Center
Charlotte, North Carolina, 28203
About this study
The purpose of the study is to determine whether noninvasive hemoglobin monitoring is sensitive and accurate enough to detect a significant downward trend in hemoglobin in patients at risk for significant bleeding. If this can be shown, it has the potential to spare patients multiple invasive blood draws as well as allow for earlier detection of significant blood loss and therefore positively impact on patient morbidity and mortality. Additionally, it may represent significant financial cost savings in that it may allow for patients to be monitored in a non-intensive care unit setting.
This will be an observational study. The continuous hemoglobin monitor will be connected to the patient and hemoglobin measurement data will be collected. Routine laboratory hemoglobin monitoring will occur concurrently at a pre-specified frequency as well as at the physician's discretion based on usual clinical information. The physician will be blinded to the continuous hemoglobin monitoring readings and therefore patient care will not be affected by the use of the monitor. Once the study has ended, the data will then be analyzed to assess for correlation between continuous hemoglobin monitoring readings and laboratory hemoglobin measurement.
Read the detailed description
No recruitment initiated
- Conditions
- Bleeding, Acute Blood Loss Anemia
- Keywords
- bleeding, blood loss, hemoglobin, hemoglobin monitoring, noninvasive monitoring
- Medical subject headings
- Hemorrhage
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 |
|---|---|---|
| Patients at risk for bleeding | Patients at risk for bleeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of hemoglobin level measurement between continuous hemoglobin monitor and laboratory analysis
Measured: minimum of every 6 hours after intensive care unit admission, shorter intervals if determined indicated by physician based on clinical information, over an estimated period of 3 days, or until patient transferred out of intensive care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2014 (estimated)
- Study startJan 2016
- Primary completionDec 2016 (estimated)
- Study completionJan 2017 (estimated)
Why it stopped: Sponsor (Masimo) suspended trial due to change in corporate ownership
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BleedingStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Toan Huynh, MD, Principal investigator, Carolinas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02138175
- Sponsor's protocol ID
- 03-14-02E
- Status last verified
- Feb 2015
- First submitted
- 12 May 2014
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Frasca D, Dahyot-Fizelier C, Catherine K, Levrat Q, Debaene B, Mimoz O. Accuracy of a continuous noninvasive hemoglobin monitor in intensive care unit patients. Crit Care Med. 2011 Oct;39(10):2277-82. doi: 10.1097/CCM.0b013e3182227e2d.
PubMed 21666449Causey MW, Miller S, Foster A, Beekley A, Zenger D, Martin M. Validation of noninvasive hemoglobin measurements using the Masimo Radical-7 SpHb Station. Am J Surg. 2011 May;201(5):592-8. doi: 10.1016/j.amjsurg.2011.01.020.
PubMed 21545905Coquin J, Dewitte A, Manach YL, Caujolle M, Joannes-Boyau O, Fleureau C, Janvier G, Ouattara A. Precision of noninvasive hemoglobin-level measurement by pulse co-oximetry in patients admitted to intensive care units for severe gastrointestinal bleeds. Crit Care Med. 2012 Sep;40(9):2576-82. doi: 10.1097/CCM.0b013e318258fb4f.
PubMed 22732278
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Hemoglobin Monitoring: Detection of Acute Blood Loss - Accurate, Timely and Cost-effective
- ClinicalTrials.gov ID
- NCT02138175
- Acronym / sponsor ID
- 03-14-02E
- Conditions
- Bleeding, Acute Blood Loss Anemia
- Keywords
- bleeding, blood loss, hemoglobin, hemoglobin monitoring, noninvasive monitoring
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Sponsor (Masimo) suspended trial due to change in corporate ownership
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 14 May 2014 (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 the study is to determine whether noninvasive hemoglobin monitoring is sensitive and accurate enough to detect a significant downward trend in hemoglobin in patients at risk for significant bleeding. If this can be shown, it has the potential to spare patients multiple invasive blood draws as well as allow for earlier detection of significant blood loss and therefore positively impact on patient morbidity and mortality. Additionally, it may represent significant financial cost savings in that it may allow for patients to be monitored in a non-intensive care unit setting.
This will be an observational study. The continuous hemoglobin monitor will be connected to the patient and hemoglobin measurement data will be collected. Routine laboratory hemoglobin monitoring will occur concurrently at a pre-specified frequency as well as at the physician's discretion based on usual clinical information. The physician will be blinded to the continuous hemoglobin monitoring readings and therefore patient care will not be affected by the use of the monitor. Once the study has ended, the data will then be analyzed to assess for correlation between continuous hemoglobin monitoring readings and laboratory hemoglobin measurement.
Detailed description
No recruitment initiated
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients at risk for bleeding | – | –Patients at risk for bleeding |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult (>18 years) patients admitted to the surgical intensive care unit for hemodynamic monitoring and serial hemoglobin measurements at high risk for bleeding (known solid organ/vascular/orthopedic injury, unexplained hypotension/tachycardia following trauma/surgery, suspected ongoing blood loss-postoperative or gastrointestinal bleeding)
Key inclusion criteria (3 listed)
- > 18 years of age
- admission to surgical intensive care unit
- suspected or high risk for ongoing blood loss
Key exclusion criteria (1 listed)
- -
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
Correlation of hemoglobin level measurement between continuous hemoglobin monitor and laboratory analysis
Time frame: minimum of every 6 hours after intensive care unit admission, shorter intervals if determined indicated by physician based on clinical information, over an estimated period of 3 days, or until patient transferred out of intensive care unit
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Background: PubMed 21666449Frasca D, Dahyot-Fizelier C, Catherine K, Levrat Q, Debaene B, Mimoz O. Accuracy of a continuous noninvasive hemoglobin monitor in intensive care unit patients. Crit Care Med. 2011 Oct;39(10):2277-82. doi: 10.1097/CCM.0b013e3182227e2d.
- Background: PubMed 21545905Causey MW, Miller S, Foster A, Beekley A, Zenger D, Martin M. Validation of noninvasive hemoglobin measurements using the Masimo Radical-7 SpHb Station. Am J Surg. 2011 May;201(5):592-8. doi: 10.1016/j.amjsurg.2011.01.020.
- Background: PubMed 22732278Coquin J, Dewitte A, Manach YL, Caujolle M, Joannes-Boyau O, Fleureau C, Janvier G, Ouattara A. Precision of noninvasive hemoglobin-level measurement by pulse co-oximetry in patients admitted to intensive care units for severe gastrointestinal bleeds. Crit Care Med. 2012 Sep;40(9):2576-82. doi: 10.1097/CCM.0b013e318258fb4f.
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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.
Toan Huynh, MD principal investigator
Carolinas Medical Center
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 Bleeding and Acute Blood Loss Anemia, run by Wake Forest University Health Sciences 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 3 inclusion and 1 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: withdrawn, as of the sponsor's last update on 25 Apr 2022. 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 was withdrawn before enrolling participants, so there are no results.
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?
Correlation of hemoglobin level measurement between continuous hemoglobin monitor and laboratory analysis (time frame: minimum of every 6 hours after intensive care unit admission, shorter intervals if determined indicated by physician based on clinical information, over an estimated period of 3 days, or until patient transferred out of intensive care unit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02138175, which also lists 3 linked publications.
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 25 Apr 2022.