AnemiaNCT01906515
Impact of SpHb Monitoring on Transfusion
A study testing Continuous non-invasive hemoglobin monitoring in people with Anemia, run by Cairo University.
Trial summary
Continuous and noninvasive hemoglobin (SpHb) monitoring provides clinicians with real-time trending of changes or lack of changes in hemoglobin, which has the potential to alter red blood cell (RBC) transfusion decision making. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Anemia
- What is being tested?
- Continuous non-invasive hemoglobin monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Dec 2012
- Phase
- Interventional
- 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 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- ASA 1,2 patients from 15 to 60 years old scheduled for neurosurgical procedure
Who cannot join
- Exclusion criteria included significant liver or renal disease, coagulopathy, pregnancy, anemia, and patients scheduled for procedures with excepted low blood loss.
About this study
Official title: Continuous and Noninvasive Hemoglobin Monitoring Reduces Red Blood Cell Transfusion During Neurosurgery: A Prospective Cohort Study
Continuous and noninvasive hemoglobin (SpHb) monitoring provides clinicians with real-time trending of changes or lack of changes in hemoglobin, which has the potential to alter red blood cell (RBC) transfusion decision making. The objective of this study was to evaluate the impact of SpHb monitoring on RBC transfusions in high blood loss surgery. The investigators hypothesize that SpHb will improve blood transfusion practice in the for of change the number of blood unit per patient and improve the outcome regards the time to take decision of transfusion trigger.
Read the detailed description
Eligible patients scheduled for neurosurgeries were enrolled into either a standard care group (Control Group) or an intervention group (SpHb Group). The Control Group received typical anesthesia care including estimated blood loss (EBL) assessment and intraoperative hemoglobin measurements from the central laboratory (Hb). Blood samples were taken when EBL was ≥15% of total blood volume. RBC transfusion was initiated if Hb was ≤10 g/dL and continued until the EBL was replaced and Hb >10g/dL was confirmed. The SpHb Group followed the same transfusion practice as the Control Group except the anesthesiologist was guided by the addition of SpHb monitoring with blood samples still taken pre- and post-transfusion. Additionally, the absolute and trend accuracy of SpHb compared to Hb was evaluated. Potential cost savings from reduced RBC utilization will be calculated if occured.
- Conditions
- Anemia
- Being tested
- Continuous non-invasive hemoglobin monitoring
- Keywords
- Anemia, Blood transfusion, non invasive hemoglobin monitoring, patient safety
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous non-invasive hemoglobin monitoringDevice
Also called Masimo Radical-7 with SpHb
Anesthesiologist is provided with real-time continuous non-invasive hemoglobin monitoring to influence care provided to patient
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Control Group received standard anesthesia care including intraoperative blood sampling when estimated blood loss was ≥15% of total blood volume and transfusion when hemoglobin was ≤10 g/dL. |
| SpHb Group. | Experimental | Continuous non-invasive hemoglobin monitoring (SpHb monitoring) was provided to the anesthesiologist to influence administration of care Receives: Device: Continuous non-invasive hemoglobin monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
RBC Transfusions Per Subject Receiving a Transfusion
Determine whether using SpHb can affect the quantity of RBC transfused, per patient receiving a transfusion.
Measured: During surgery (an average of about 4 hours)
The Effect of SpHb on Transfusion Timeline
Length of time it takes to initiate a RBC transfusion after the need was first established.
Measured: During surgery (an average of about 4 hours)
Secondary outcomes (1)
SpHb Absolute and Trend Accuracy
To assess absolute accuracy, or single point comparison, paired SpHb and Hb measurements were compared pre- and post- transfusion and bias and standard deviation were calculated. A Bland Altman graph with limits of agreement (1.96 x standard deviation, adjusted for the bias) was plotted to show agreement across the range of values. To assess trending, a regression plot of changes in Hb and corresponding changes in SpHb was plotted and a coefficient of determination (R2) was calculated
Measured: During surgery (an average of about 4 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2013 (estimated)
- Study startFeb 2012
- Primary completionOct 2012
- Study completionDec 2012
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.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Masimo Corporation
- Responsible party
- Principal investigator, wael awada, Cairo University
- Investigators
- Wael N Awada, MD, Principal investigator, Department of Anesthesia, ICU, and Pain Management, Cairo University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01906515
- Sponsor's protocol ID
- doctor19
- Status last verified
- Jan 2014
- First submitted
- 13 Jul 2013
- Last updated
- 27 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous and Noninvasive Hemoglobin Monitoring Reduces Red Blood Cell Transfusion During Neurosurgery: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT01906515
- Acronym / sponsor ID
- doctor19
- Conditions
- Anemia
- Keywords
- Anemia, Blood transfusion, non invasive hemoglobin monitoring, patient safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Masimo Corporation
- Study start
- Feb 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 24 Jul 2013 (estimated)
- Results
- Posted 20 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Continuous and noninvasive hemoglobin (SpHb) monitoring provides clinicians with real-time trending of changes or lack of changes in hemoglobin, which has the potential to alter red blood cell (RBC) transfusion decision making. The objective of this study was to evaluate the impact of SpHb monitoring on RBC transfusions in high blood loss surgery. The investigators hypothesize that SpHb will improve blood transfusion practice in the for of change the number of blood unit per patient and improve the outcome regards the time to take decision of transfusion trigger.
Detailed description
Eligible patients scheduled for neurosurgeries were enrolled into either a standard care group (Control Group) or an intervention group (SpHb Group). The Control Group received typical anesthesia care including estimated blood loss (EBL) assessment and intraoperative hemoglobin measurements from the central laboratory (Hb). Blood samples were taken when EBL was ≥15% of total blood volume. RBC transfusion was initiated if Hb was ≤10 g/dL and continued until the EBL was replaced and Hb >10g/dL was confirmed. The SpHb Group followed the same transfusion practice as the Control Group except the anesthesiologist was guided by the addition of SpHb monitoring with blood samples still taken pre- and post-transfusion. Additionally, the absolute and trend accuracy of SpHb compared to Hb was evaluated. Potential cost savings from reduced RBC utilization will be calculated if occured.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Control Group received standard anesthesia care including intraoperative blood sampling when estimated blood loss was ≥15% of total blood volume and transfusion when hemoglobin was ≤10 g/dL. |
| SpHb Group. | Experimental | Device: Continuous non-invasive hemoglobin monitoringContinuous non-invasive hemoglobin monitoring (SpHb monitoring) was provided to the anesthesiologist to influence administration of care |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- ASA 1,2 patients from 15 to 60 years old scheduled for neurosurgical procedure
Key exclusion criteria (1 listed)
- Exclusion criteria included significant liver or renal disease, coagulopathy, pregnancy, anemia, and patients scheduled for procedures with excepted low blood loss.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous non-invasive hemoglobin monitoringAlso: Masimo Radical-7 with SpHbAnesthesiologist is provided with real-time continuous non-invasive hemoglobin monitoring to influence care provided to patient | Device | SpHb Group. |
Primary outcome
RBC Transfusions Per Subject Receiving a Transfusion
Time frame: During surgery (an average of about 4 hours)
Determine whether using SpHb can affect the quantity of RBC transfused, per patient receiving a transfusion.
The Effect of SpHb on Transfusion Timeline
Time frame: During surgery (an average of about 4 hours)
Length of time it takes to initiate a RBC transfusion after the need was first established.
1 secondary outcome
SpHb Absolute and Trend Accuracy
Time frame: During surgery (an average of about 4 hours)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Wael N Awada, MD principal investigator
Department of Anesthesia, ICU, and Pain Management, Cairo University, Egypt
Questions about this trial
What is this clinical trial studying?
A study testing Continuous non-invasive hemoglobin monitoring in people with Anemia, run by Cairo University.
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 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: finished, as of the sponsor's last update on 27 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
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 20 Jan 2014). 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?
RBC Transfusions Per Subject Receiving a Transfusion (time frame: During surgery (an average of about 4 hours)). 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?
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 27 Feb 2014.