Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01686659
Recruitment Status : Recruiting
First Posted : September 18, 2012
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
Society for the Advancement of Blood Management, Inc

Tracking Information
First Submitted Date  ICMJE August 29, 2012
First Posted Date  ICMJE September 18, 2012
Last Update Posted Date April 23, 2018
Study Start Date  ICMJE September 2012
Estimated Primary Completion Date December 2018   (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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE 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  ICMJE
  • 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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 12, 2012)
470
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2019
Estimated Primary Completion Date December 2018   (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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Richard Melseth 602-343-7458 rmelseth@sabm.org
Contact: Mazyar Javidroozi, MD, PhD 201-894-3917 mazyarjr@yahoo.com
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  ICMJE 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 April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP