HemorrhageNCT01753960
Surgical Blood Management Using Noninvasive and Continuous Hemoglobin Monitoring(NACHO)
An observational study of Hemorrhage, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to determine whether Noninvasive and Continuous Hemoglobin Monitoring (NACHO) for Surgical Blood Management affects transfusion decision making algorithm in the operating room. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhage
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2013to Jan 2014
- 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: Study population in this study is defined at two levels: 1.Consenting eligible Anesthesiologists, and 2. Eligible patients under the case of the consenting eligible Anesthesiologist. Each level has its own eligibility criteria.
Who may be able to join
- Consenting anesthesiologist
- Anticipate to manage at least 10 cases per month
- At least 3-year post-graduate clinical experience as an anesthesiologist responsible for making transfusion decisions for individual patients
- 150 Adult patients undergoing major surgeries associated with possibility of significant blood loss (e.g. such that blood is cross-matched and available before the start of the case as per hospital routine practice).
- Consenting patients who are primarily managed by the consenting anesthesiologists participating in the study
- At least one finger available and accessible for performing non-invasive hemoglobin monitoring.
Who cannot join
- Not meeting the appropriate licensing requirements
- No being board-certified in Anesthesiology
- Inability or unwillingness to complete study-related procedures, including undergoing training with regards to using and interpreting the monitor data in the operating room
- Eligible patients under the case of the consenting eligible Anesthesiologist.
- 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
Show all 15Show fewer
- 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
- Patients being treated by any artificial oxygen carriers within 30 days of hospital stay
- Patients being managed outside of an operating room, 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
1 site in 1 country.
About this study
Official title: Noninvasive and Continuous Hemoglobin Monitoring for Surgical Blood Management (NACHO) - Matched-pair Cluster-randomized Controlled Trial
The purpose of this study is to determine whether Noninvasive and Continuous Hemoglobin Monitoring (NACHO) for Surgical Blood Management affects transfusion decision making algorithm in the operating room.
Read the detailed description
Blood transfusions are associated with various risks including viral infections, delayed wound healing, transfusion related acute lung injury and cardiovascular complications. Despite limitations, and ongoing efforts to identify and validate other more-physiologically-relevant "triggers" for blood transfusions, hemoglobin-based transfusion triggers are still commonly used in practice, as well as in all currently available transfusion guidelines, alone, or in combination with other parameters. In the operating room the anesthesiologist has to withdraw blood from the patient and send it to the lab or the blood gas machine to achieve hemoglobin levels. It may be suggested that the ability to continuously monitor hemoglobin levels may help physicians to take more appropriate transfusion decisions; i.e, the physicians will either identify critical decreases in hemoglobin levels earlier and respond appropriately or avoid over-transfusing when hemoglobin levels have not decreased yet. Accordingly, monitors of hemoglobin levels are used in the operating theatre in many centers, although their blood-conserving effect has not been proven yet.
We believe that the transfusion decision making algorithm in the operating room relies less heavily on "on spot" measures of hemoglobin levels but rather on patient's comorbidities, expected additional bleeding according to the surgery and the surgeon, the course of the operation (the operating field is "open" and thus surgeons can tell if it is oozing or frank bleeding, if they can control bleeding promptly or not etc..), hemodynamic data available from the different invasive and non-invasive monitors, pressure from the surgeon, etc. It is therefore suggested that continuous monitoring of hemoglobin levels may be less relevant in this environment.
Specific Aims/Hypothesis:
- The primary hypothesis is that continuous noninvasive hemoglobin monitoring will not reduce the number of blood 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 not be earlier warning of critical drops in hemoglobin, resulting in less frequent complications compared with patients who are not being monitored with continuous noninvasive hemoglobin.
- Conditions
- Hemorrhage
- 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 |
|---|---|---|
| Control group | Anesthesiologists without access to data from a continuous noninvasive hemoglobin monitoring device during surgery. | |
| SpHb group | Anesthesiologists with access to data from a continuous noninvasive hemoglobin monitoring device during surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of allogeneic Red Blood Cells (RBC) units transfused intraoperatively
Measured: perioperative period untill the end of surgery
Secondary outcomes (5)
Hospital stay treatment - Occurrence of any allogeneic RBC transfusions intraoperatively
Measured: From end of surgery until 30 days after surgery
Hospital stay treatment - Total number of allogeneic RBC units transfused perioperatively during hospital stay
Measured: From end of surgery until 30 days after surgery
Hospital stay treatment - Incidence of new (or worsening of pre-existing) ischemic events
Measured: From end of surgery until 30 days after surgery
Hospital stay treatment - 30-day mortality
Measured: From end of surgery until 30 days after surgery
Hospital stay treatment - Length of post-surgery hospital stay
Measured: From end of surgery until 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionJan 2014 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhageStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Idit Matot, professor, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01753960
- Sponsor's protocol ID
- TASMC-12-IM-0561-12-CTIL
- Status last verified
- Jan 2013
- First submitted
- 5 Nov 2012
- Last updated
- 3 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive and Continuous Hemoglobin Monitoring for Surgical Blood Management (NACHO) - Matched-pair Cluster-randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01753960
- Acronym / sponsor ID
- TASMC-12-IM-0561-12-CTIL
- Conditions
- Hemorrhage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jan 2013
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 20 Dec 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 determine whether Noninvasive and Continuous Hemoglobin Monitoring (NACHO) for Surgical Blood Management affects transfusion decision making algorithm in the operating room.
Detailed description
Blood transfusions are associated with various risks including viral infections, delayed wound healing, transfusion related acute lung injury and cardiovascular complications. Despite limitations, and ongoing efforts to identify and validate other more-physiologically-relevant "triggers" for blood transfusions, hemoglobin-based transfusion triggers are still commonly used in practice, as well as in all currently available transfusion guidelines, alone, or in combination with other parameters. In the operating room the anesthesiologist has to withdraw blood from the patient and send it to the lab or the blood gas machine to achieve hemoglobin levels. It may be suggested that the ability to continuously monitor hemoglobin levels may help physicians to take more appropriate transfusion decisions; i.e, the physicians will either identify critical decreases in hemoglobin levels earlier and respond appropriately or avoid over-transfusing when hemoglobin levels have not decreased yet. Accordingly, monitors of hemoglobin levels are used in the operating theatre in many centers, although their blood-conserving effect has not been proven yet.
We believe that the transfusion decision making algorithm in the operating room relies less heavily on "on spot" measures of hemoglobin levels but rather on patient's comorbidities, expected additional bleeding according to the surgery and the surgeon, the course of the operation (the operating field is "open" and thus surgeons can tell if it is oozing or frank bleeding, if they can control bleeding promptly or not etc..), hemodynamic data available from the different invasive and non-invasive monitors, pressure from the surgeon, etc. It is therefore suggested that continuous monitoring of hemoglobin levels may be less relevant in this environment.
Specific Aims/Hypothesis:
- The primary hypothesis is that continuous noninvasive hemoglobin monitoring will not reduce the number of blood 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 not be earlier warning of critical drops in hemoglobin, resulting in less frequent complications compared with patients who are not being monitored with continuous noninvasive hemoglobin.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –Anesthesiologists without access to data from a continuous noninvasive hemoglobin monitoring device during surgery. |
| SpHb group | – | –Anesthesiologists with access to data from a continuous noninvasive hemoglobin monitoring device during surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population in this study is defined at two levels: 1.Consenting eligible Anesthesiologists, and 2. Eligible patients under the case of the consenting eligible Anesthesiologist. Each level has its own eligibility criteria.
Key inclusion criteria (6 listed)
- 150 Adult patients undergoing major surgeries associated with possibility of significant blood loss (e.g. such that blood is cross-matched and available before the start of the case as per hospital routine practice).
- Consenting patients who are primarily managed by the consenting anesthesiologists participating in the study
- At least one finger available and accessible for performing non-invasive hemoglobin monitoring.
Key exclusion criteria (15 listed)
- Eligible patients under the case of the consenting eligible Anesthesiologist.
- 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)
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
Number of allogeneic Red Blood Cells (RBC) units transfused intraoperatively
Time frame: perioperative period untill the end of surgery
5 secondary outcomes
Hospital stay treatment - Occurrence of any allogeneic RBC transfusions intraoperatively
Time frame: From end of surgery until 30 days after surgery
Hospital stay treatment - Total number of allogeneic RBC units transfused perioperatively during hospital stay
Time frame: From end of surgery until 30 days after surgery
Hospital stay treatment - Incidence of new (or worsening of pre-existing) ischemic events
Time frame: From end of surgery until 30 days after surgery
Hospital stay treatment - 30-day mortality
Time frame: From end of surgery until 30 days after surgery
Hospital stay treatment - Length of post-surgery hospital stay
Time frame: From end of surgery until 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2013.
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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.
Idit Matot, professor principal investigator
Tel-Aviv Sourasky 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 Hemorrhage, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 6 inclusion and 15 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 3 Jan 2013. 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 Israel. 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 Idit Matot, Professor (97236974758 ext. 4758, iditm@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of allogeneic Red Blood Cells (RBC) units transfused intraoperatively (time frame: perioperative period untill the end 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 3 Jan 2013.