SurgeryNACHONCT01686659
Noninvasive and Continuous Hemoglobin Monitoring for Surgical Blood Management
A study testing Continuous Noninvasive Hemoglobin Monitoring in people with Surgery, run by Society for the Advancement of Blood Management, Inc at 8 sites in 4 countries.
Trial summary
This is a multi-center cluster-randomized trial with the following Specific Aims: To evaluate if continuous noninvasive hemoglobin monitoring will reduce the RBC transfusions in patients undergoing surgeries associated with a significant risk of bleeding. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery
- What is being tested?
- Continuous Noninvasive Hemoglobin Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 470 participants
- Where
- 8 sitesin 4 countries
- Study dates
- Sep 2012to Jun 2019
- Phase
- Interventional
- 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
Who may be able to join
- Adult patients undergoing one of the listed major surgeries associated with possibility of significant blood loss
- Consenting patients who are primarily managed by the consenting Anesthesiologists participating in the study (Not applicable at participating centers which have obtained a waiver of informed consent for the patients from their respective IRB)
- At least one finger available and accessible for performing non-invasive hemoglobin monitoring (preoperative perfusion index greater than 0.5)
Who cannot join
- Any patients who do not fit the criteria for use of sensor, specifically, any patient with nail polish and/or a nail deformity, or obstructed physical access (e.g. due to bandage) to all fingers that would be used for sensor placement, in a manner that interferes with satisfactory sensor placement
- Any patients being monitored with motor evoked potential devices
- Any patients with a known hemoglobinopathy
- Any patients undergoing Cardio-Pulmonary Bypass (CPB)
- Any patients who cannot be transfused or has refused consent for a blood transfusion
- Patients who are moribund/salvage cases as determined by the participating Anesthesiologist in charge of management of the patient in the operating room
Show all 12Show fewer
- Patients being treated by any artificial oxygen carriers within 30 days of hospital stay
- Patients who are actively enrolled in or within 30 days of completion of any other study (except for purely observational studies with no intervention)
- Patients being managed outside of an operating room in the participating centers, or in operating room with conditions not conducive to perform and complete the study procedures (including use of the hemoglobin monitoring device)
- Patients younger than 18 years old
- Patients who are pregnant
- Any patients expected to receive transfusion preoperatively
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
United States5 sites, 2 recruiting
- Recruiting
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Sergio Bergese, MD
- Completed
Duke University Medical Center
Durham, North Carolina, 27710
- Completed
Swedish Medical Center
Seattle, Washington, 98122
- Recruiting
Stanford University
Stanford, California, 94305
Pedro P Tanaka, MD, PhD
Pedro P Tanaka, MD, PhD
- Completed
Montefiore Medical Center
The Bronx, New York, 10467
Japan1 site
- Completed
Sapporo Medical University School of Medicine
Chuo-ku Sapporo, Hokkaido, 060-8543
About this study
This is a multi-center cluster-randomized trial with the following Specific Aims:
- To evaluate if continuous noninvasive hemoglobin monitoring will reduce the RBC transfusions in patients undergoing surgeries associated with a significant risk of bleeding.
- To evaluate if patients monitored with continuous noninvasive hemoglobin experience less frequent complications and shorter hospital stay compared with patients who are not being monitored with continuous noninvasive hemoglobin.
Read more
Accordingly, the study hypotheses are defined as follows:
- The primary null hypothesis is that continuous noninvasive hemoglobin monitoring will not reduce the RBC transfusions in patients undergoing surgeries associated with a significant risk of bleeding.
- The secondary hypothesis is that in patients monitored with continuous noninvasive hemoglobin, there will be earlier warning of critical drops in hemoglobin, and thus, there will be less frequent complications compared with patients who are not being monitored with continuous noninvasive hemoglobin.
Read the detailed description
This is a matched-pair cluster-randomized controlled trial. At each participating centers, consenting eligible Anesthesiologists will be grouped into matched pairs based on their practice characteristics and experience (namely, their main surgical service/procedures and their years of experience working as a clinician responsible for making transfusion decisions). From each pair, Anesthesiologists will be randomly allocated to either treat their patients while having access to data from a continuous noninvasive hemoglobin monitoring device (total hemoglobin [SpHb] and Pleth Variability Index [PVI]) (SpHb group) or without access to SpHb/PVI data, under standard of care (control group). Regardless of randomization, all patients will be monitored with the device but the data will be blinded and not be available to the Anesthesiologist to be used in the management of the control group. Only in the SpHb group, the SpHb/PVI data will be provided live to the Anesthesiologist, to be used during management of the patients.
- Conditions
- Surgery
- Being tested
- Continuous Noninvasive Hemoglobin Monitoring
- Keywords
- Transfusion, Continuous Hemoglobin Monitoring, SpHb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Noninvasive Hemoglobin MonitoringDevice
Also called SpHb, Radical-7, Radical 7 Pulse CO-Oximeter
Availability of data from a continuous noninvasive hemoglobin monitoring device (total hemoglobin [SpHb] and Pleth Variability Index [PVI]) to the clinicians in the operating room
| Study group | Role | What they receive |
|---|---|---|
| SpHb Arm | Experimental | These are the patients whose primary anesthesiologists have been allocated to treat them while having access to data from a continuous noninvasive hemoglobin monitoring device Receives: Device: Continuous Noninvasive Hemoglobin Monitoring |
| Control Arm | No intervention | These are the patients whose primary anesthesiologists have been allocated to treat them without having access to data from a continuous noninvasive hemoglobin monitoring device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of Intraoperative RBC Transfusion
Number of allogeneic RBC units transfused intraoperatively per patient
Measured: From the first surgical incision to the wound closure
Secondary outcomes (5)
Intraoperative RBC Transfusion Rate
Occurrence of any allogeneic RBC transfusions intraoperatively
Measured: From the first surgical incision to the wound closure
Amount of Perioperative RBC Transfusion
Total number of allogeneic RBC units transfused perioperatively during hospital stay
Measured: From time of admission to the hospital to the time of discharge or death whichever sooner (an estimated average of 6 days)
Ischemic Events
Incidence of new (or worsening of pre-existing) ischemic events
Measured: From time of surgery to the time of discharge or death whichever sooner (an estimated average of 5 days)
Mortality
Any death occuring during surgery or within 30-day period following the surgery
Measured: From time of surgery to 30 days after the surgery
Length of Stay
Length of post-surgery hospital stay
Measured: From time of surgery to time of discharge from hospital (an estimated average of 5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2018 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 470 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Society for the Advancement of Blood Management, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aryeh Shander, MD, Principal investigator, Englewood Hospital & Medical CenterMazyar Javidroozi, MD, PhD, Study director, Englewood Hospital & Medical CenterAryeh Shander, MD, Study chair, Englewood Hospital & Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01686659
- Sponsor's protocol ID
- NACHO
- Acronym
- NACHO
- Status last verified
- Apr 2018
- First submitted
- 29 Aug 2012
- Last updated
- 23 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive and Continuous Hemoglobin Monitoring for Surgical Blood Management
- ClinicalTrials.gov ID
- NCT01686659
- Acronym / sponsor ID
- NACHO / NACHO
- Conditions
- Surgery
- Keywords
- Transfusion, Continuous Hemoglobin Monitoring, SpHb
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 470 participants (estimated)
- Lead sponsor
- Society for the Advancement of Blood Management, IncIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 18 Sep 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.
This is a multi-center cluster-randomized trial with the following Specific Aims:
- To evaluate if continuous noninvasive hemoglobin monitoring will reduce the RBC transfusions in patients undergoing surgeries associated with a significant risk of bleeding.
- To evaluate if patients monitored with continuous noninvasive hemoglobin experience less frequent complications and shorter hospital stay compared with patients who are not being monitored with continuous noninvasive hemoglobin.
Accordingly, the study hypotheses are defined as follows:
- The primary null hypothesis is that continuous noninvasive hemoglobin monitoring will not reduce the RBC transfusions in patients undergoing surgeries associated with a significant risk of bleeding.
- The secondary hypothesis is that in patients monitored with continuous noninvasive hemoglobin, there will be earlier warning of critical drops in hemoglobin, and thus, there will be less frequent complications compared with patients who are not being monitored with continuous noninvasive hemoglobin.
Detailed description
This is a matched-pair cluster-randomized controlled trial. At each participating centers, consenting eligible Anesthesiologists will be grouped into matched pairs based on their practice characteristics and experience (namely, their main surgical service/procedures and their years of experience working as a clinician responsible for making transfusion decisions). From each pair, Anesthesiologists will be randomly allocated to either treat their patients while having access to data from a continuous noninvasive hemoglobin monitoring device (total hemoglobin [SpHb] and Pleth Variability Index [PVI]) (SpHb group) or without access to SpHb/PVI data, under standard of care (control group). Regardless of randomization, all patients will be monitored with the device but the data will be blinded and not be available to the Anesthesiologist to be used in the management of the control group. Only in the SpHb group, the SpHb/PVI data will be provided live to the Anesthesiologist, to be used during management of the patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SpHb Arm | Experimental | Device: Continuous Noninvasive Hemoglobin MonitoringThese are the patients whose primary anesthesiologists have been allocated to treat them while having access to data from a continuous noninvasive hemoglobin monitoring device |
| Control Arm | No intervention | –These are the patients whose primary anesthesiologists have been allocated to treat them without having access to data from a continuous noninvasive hemoglobin monitoring device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients undergoing one of the listed major surgeries associated with possibility of significant blood loss
- Consenting patients who are primarily managed by the consenting Anesthesiologists participating in the study (Not applicable at participating centers which have obtained a waiver of informed consent for the patients from their respective IRB)
- At least one finger available and accessible for performing non-invasive hemoglobin monitoring (preoperative perfusion index greater than 0.5)
Key exclusion criteria (12 listed)
- Any patients who do not fit the criteria for use of sensor, specifically, any patient with nail polish and/or a nail deformity, or obstructed physical access (e.g. due to bandage) to all fingers that would be used for sensor placement, in a manner that interferes with satisfactory sensor placement
- Any patients being monitored with motor evoked potential devices
- Any patients with a known hemoglobinopathy
- Any patients undergoing Cardio-Pulmonary Bypass (CPB)
- Any patients who cannot be transfused or has refused consent for a blood transfusion
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 Noninvasive Hemoglobin MonitoringAlso: SpHb, Radical-7, Radical 7 Pulse CO-OximeterAvailability of data from a continuous noninvasive hemoglobin monitoring device (total hemoglobin [SpHb] and Pleth Variability Index [PVI]) to the clinicians in the operating room | Device | SpHb Arm |
Primary outcome
Amount of Intraoperative RBC Transfusion
Time frame: From the first surgical incision to the wound closure
Number of allogeneic RBC units transfused intraoperatively per patient
5 secondary outcomes
Intraoperative RBC Transfusion Rate
Time frame: From the first surgical incision to the wound closure
Amount of Perioperative RBC Transfusion
Time frame: From time of admission to the hospital to the time of discharge or death whichever sooner (an estimated average of 6 days)
Ischemic Events
Time frame: From time of surgery to the time of discharge or death whichever sooner (an estimated average of 5 days)
Mortality
Time frame: From time of surgery to 30 days after the surgery
Length of Stay
Time frame: From time of surgery to time of discharge from hospital (an estimated average of 5 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2018.
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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.
Aryeh Shander, MD principal investigator
Englewood Hospital & Medical Center
Mazyar Javidroozi, MD, PhD study director
Englewood Hospital & Medical Center
Aryeh Shander, MD study chair
Englewood Hospital & Medical Center
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Noninvasive Hemoglobin Monitoring in people with Surgery, run by Society for the Advancement of Blood Management, Inc at 8 sites in 4 countries.
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 12 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: status not confirmed, as of the sponsor's last update on 23 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, France, Italy, Japan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Richard Melseth (602-343-7458, rmelseth@sabm.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of Intraoperative RBC Transfusion (time frame: From the first surgical incision to the wound closure). 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 23 Apr 2018.