Brief 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.
* 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.
* 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.
Brief Title
Noninvasive and Continuous Hemoglobin Monitoring for Surgical Blood Management
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.
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
602-343-7458
Central Contact Email
rmelseth@sabm.org
Central Contact Role
Contact
Central Contact Phone
201-894-3917
Central Contact Email
mazyarjr@yahoo.com
Completion Date
Completion Date Type
Estimated
Conditions
Surgery
Eligibility Criteria
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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
* 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
* 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)
Exclusion Criteria:
* 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
* 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
Inclusion Criteria
Inclusion Criteria:
* 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)
* 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)
Gender
All
Gender Based
false
Keywords
Transfusion
Continuous Hemoglobin Monitoring
SpHb
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT01686659
Org Class
Industry
Org Full Name
Society for the Advancement of Blood Management, Inc
Org Study Id
NACHO
Overall Status
Unknown status
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Noninvasive and Continuous Hemoglobin Monitoring for Surgical Blood Management
Primary Outcomes
Outcome Description
Number of allogeneic RBC units transfused intraoperatively per patient
Outcome Measure
Amount of Intraoperative RBC Transfusion
Outcome Time Frame
From the first surgical incision to the wound closure
Secondary Outcomes
Outcome Description
Occurrence of any allogeneic RBC transfusions intraoperatively
Outcome Time Frame
From the first surgical incision to the wound closure
Outcome Measure
Intraoperative RBC Transfusion Rate
Outcome Description
Total number of allogeneic RBC units transfused perioperatively during hospital stay
Outcome Time Frame
From time of admission to the hospital to the time of discharge or death whichever sooner (an estimated average of 6 days)
Outcome Measure
Amount of Perioperative RBC Transfusion
Outcome Description
Incidence of new (or worsening of pre-existing) ischemic events
Outcome Time Frame
From time of surgery to the time of discharge or death whichever sooner (an estimated average of 5 days)
Outcome Measure
Ischemic Events
Outcome Description
Any death occuring during surgery or within 30-day period following the surgery
Outcome Time Frame
From time of surgery to 30 days after the surgery
Outcome Measure
Mortality
Outcome Description
Length of post-surgery hospital stay
Outcome Time Frame
From time of surgery to time of discharge from hospital (an estimated average of 5 days)
Outcome Measure
Length of Stay
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Ellise Delphin
Investigator Email
edelphin@montefiore.org
Investigator Phone