HemorrhageNCT01709786
Non-Invasive Hemoglobin Monitoring in Patients With Hemorrhage
An observational study of Hemorrhage, run by University of Cincinnati at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hemorrhage
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Dec 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- admitted to surgical intensive care unit (SICU), and
- at risk of ongoing bleeding, and
- requires serial CBC measurements
Who cannot join
- < 18 years of age, or
- a prisoner, or
- unable to have pulse oximetry readings (due to injuries, burns, amputations, or related problems)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-Invasive Hemoglobin Monitoring in the Patient With Suspected Hemorrhage
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.
Read the detailed description
Anemia and bleeding are major causes of morbidity and mortality in both surgical and nonsurgical patients. The current standard of care for monitoring patients at risk for bleeding is serial measurement of hemoglobin levels. At present, the photometric cyanmethemoglobin method is the most widely used technique for monitoring hemoglobin in the lab, and is currently the gold standard. However, this method has potential for delay before final results are obtained.
Immediate hemoglobin measurements are available with portable point-of-care devices such as the iSTAT, which can produce a measurement of hemoglobin concentration in less than 1 minute. Unfortunately, the accuracy of this device has been reported to vary with hemoglobin level, and as such may not be as accurate in detecting blood loss when compared with the gold standard of laboratory analysis.
Recently, a noninvasive, spectrophotometry-based monitoring technology has been developed. This novel technology measures the differential optical density of wavelengths of light passed through the finger in a method similar to conventional pulse oximetry. While some studies have reported that this device appears to be accurate in patients undergoing elective surgical procedures, more recent work suggests that this accuracy degrades with increased blood loss, lower oximeter signal quality and lower absolute Hgb values.
We will evaluate the accuracy of point-of-care and non-invasive SpHb measurements and utility of continuous hemoglobin monitoring in an intensive care unit setting. If these methods of rapid hemoglobin measurement can be validated in patients at risk for ongoing hemorrhage, use of this technology may result in earlier detection of ongoing hemorrhage, expedite appropriate treatment, and improve patient outcomes.
- Conditions
- Hemorrhage
- Keywords
- Hemorrhage, Hemoglobin, Non-invasive monitoring, Medical device accuracy
- 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 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: n ≥ 1 measurements were taken each day. All measurements (n ≥ 7) from ICU Days 1-7 were used in Bland-Altman analysis, equally weighted.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for HemorrhageStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe 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
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- United States Air Force
- Responsible party
- Principal investigator, Betty Tsuei, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01709786
- Sponsor's protocol ID
- Tsuei-2012-06
- Status last verified
- May 2016
- First submitted
- 12 Oct 2012
- Last updated
- 9 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 14453500International 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.
PubMed 5608692Gayat 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.
PubMed 22238693May 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.
PubMed 22116696Butwick 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.
PubMed 21640577Hahn 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.
PubMed 21039345Myers 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.
PubMed 19951386Santora 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.
PubMed 19951382Lamhaut 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.
PubMed 21716091Applegate 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.
PubMed 22133758Tsuei 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.
PubMed 25159346
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Hemoglobin Monitoring in the Patient With Suspected Hemorrhage
- ClinicalTrials.gov ID
- NCT01709786
- Acronym / sponsor ID
- Tsuei-2012-06
- Conditions
- Hemorrhage
- Keywords
- Hemorrhage, Hemoglobin, Non-invasive monitoring, Medical device accuracy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- United States Air Force
- Study start
- Sep 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 18 Oct 2012 (estimated)
- Results
- Posted 9 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Anemia and bleeding are major causes of morbidity and mortality in both surgical and nonsurgical patients. The current standard of care for monitoring patients at risk for bleeding is serial measurement of hemoglobin levels. At present, the photometric cyanmethemoglobin method is the most widely used technique for monitoring hemoglobin in the lab, and is currently the gold standard. However, this method has potential for delay before final results are obtained.
Immediate hemoglobin measurements are available with portable point-of-care devices such as the iSTAT, which can produce a measurement of hemoglobin concentration in less than 1 minute. Unfortunately, the accuracy of this device has been reported to vary with hemoglobin level, and as such may not be as accurate in detecting blood loss when compared with the gold standard of laboratory analysis.
Recently, a noninvasive, spectrophotometry-based monitoring technology has been developed. This novel technology measures the differential optical density of wavelengths of light passed through the finger in a method similar to conventional pulse oximetry. While some studies have reported that this device appears to be accurate in patients undergoing elective surgical procedures, more recent work suggests that this accuracy degrades with increased blood loss, lower oximeter signal quality and lower absolute Hgb values.
We will evaluate the accuracy of point-of-care and non-invasive SpHb measurements and utility of continuous hemoglobin monitoring in an intensive care unit setting. If these methods of rapid hemoglobin measurement can be validated in patients at risk for ongoing hemorrhage, use of this technology may result in earlier detection of ongoing hemorrhage, expedite appropriate treatment, and improve patient outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- admitted to surgical intensive care unit (SICU), and
- at risk of ongoing bleeding, and
- requires serial CBC measurements
Key exclusion criteria (3 listed)
- < 18 years of age, or
- a prisoner, or
- unable to have pulse oximetry readings (due to injuries, burns, amputations, or related problems)
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
CBC Hemoglobin Measurement Compared to Non-invasive Radical-7 Measurement
Time frame: n ≥ 1 measurements were taken each day. All measurements (n ≥ 7) from ICU Days 1-7 were used in Bland-Altman analysis, equally weighted.
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.
CBC Hemoglobin Measurement Compared to Non-invasive iSTAT Measurement
Time frame: n ≥ 1 measurements were taken each day. All measurements (n ≥ 7) from ICU Days 1-7 were used in Bland-Altman analysis, equally weighted.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 14453500van 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.
- Background: PubMed 5608692International 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.
- Background: PubMed 22238693Gayat 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.
- Background: PubMed 22116696May 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.
- Background: PubMed 21640577Butwick 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.
- Background: PubMed 21039345Hahn 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.
- Background: PubMed 19951386Myers 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.
- Background: PubMed 19951382Santora 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.
- Background: PubMed 21716091Lamhaut 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.
- Background: PubMed 22133758Applegate 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.
- Derived from this study: PubMed 25159346Tsuei 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.
- Individual participant dataSharing planned: No
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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.
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 Hemorrhage, run by University of Cincinnati 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 3 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 9 Aug 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?
Yes. Results are posted in the registry (first posted 9 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
CBC Hemoglobin Measurement Compared to Non-invasive Radical-7 Measurement (time frame: n ≥ 1 measurements were taken each day. All measurements (n ≥ 7) from ICU Days 1-7 were used in Bland-Altman analysis, equally weighted.). The study lists 2 primary outcomes in all. 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 NCT01709786, which also lists 11 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 9 Aug 2016.