Noninvasive and Continuous Hemoglobin Monitoring for Surgical Blood Management (NACHO)

Tracking Information
First Submitted Date ICMJE	August 29, 2012
First Posted Date ICMJE	September 18, 2012
Last Update Posted Date	November 30, 2015
Study Start Date ICMJE	September 2012
Estimated Primary Completion Date	September 2016 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: September 12, 2012)	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
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01686659 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: September 12, 2012)	Intraoperative RBC Transfusion Rate [ Time Frame: From the first surgical incision to the wound closure ]Occurrence of any allogeneic RBC transfusions intraoperatively; 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) ]Total number of allogeneic RBC units transfused perioperatively during hospital stay; Ischemic Events [ Time Frame: From time of surgery to the time of discharge or death whichever sooner (an estimated average of 5 days) ]Incidence of new (or worsening of pre-existing) ischemic events; Mortality [ Time Frame: From time of surgery to 30 days after the surgery ]Any death occuring during surgery or within 30-day period following the surgery; Length of Stay [ Time Frame: From time of surgery to time of discharge from hospital (an estimated average of 5 days) ]Length of post-surgery hospital stay
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Noninvasive and Continuous Hemoglobin Monitoring for Surgical Blood Management
Official Title ICMJE	Noninvasive and Continuous Hemoglobin Monitoring for Surgical Blood Management
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.
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 Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
Condition ICMJE	Surgery
Intervention ICMJE	Device: Continuous Noninvasive Hemoglobin Monitoring; 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; Other Names: SpHb; Radical-7; Radical 7 Pulse CO-Oximeter
Study Arms	Experimental: SpHb Arm 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 Intervention: Device: Continuous Noninvasive Hemoglobin Monitoring; No Intervention: Control Arm 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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Estimated Enrollment ICMJE; (submitted: September 12, 2012)	470
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	March 2017
Estimated Primary Completion Date	September 2016 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	France, Italy, Japan, United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01686659
Other Study ID Numbers ICMJE	NACHO
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Society for the Advancement of Blood Management, Inc
Study Sponsor ICMJE	Society for the Advancement of Blood Management, Inc
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Aryeh Shander, MD Englewood Hospital & Medical Center Study Director: Mazyar Javidroozi, MD, PhD Englewood Hospital & Medical Center Study Chair: Aryeh Shander, MD Englewood Hospital & Medical Center
PRS Account	Society for the Advancement of Blood Management, Inc
Verification Date	November 2015
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP