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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Society for the Advancement of Blood Management, Inc
Sponsor:
Information provided by (Responsible Party):
Society for the Advancement of Blood Management, Inc
ClinicalTrials.gov Identifier:
NCT01686659
First received: August 29, 2012
Last updated: August 12, 2013
Last verified: August 2013

August 29, 2012
August 12, 2013
September 2012
September 2013   (final data collection date for primary outcome measure)
Amount of Intraoperative RBC Transfusion [ Time Frame: From the first surgical incision to the wound closure ] [ Designated as safety issue: No ]
Number of allogeneic RBC units transfused intraoperatively per patient
Same as current
Complete list of historical versions of study NCT01686659 on ClinicalTrials.gov Archive Site
  • Intraoperative RBC Transfusion Rate [ Time Frame: From the first surgical incision to the wound closure ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: Yes ]
    Incidence of new (or worsening of pre-existing) ischemic events
  • Mortality [ Time Frame: From time of surgery to 30 days after the surgery ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: No ]
    Length of post-surgery hospital stay
Same as current
Not Provided
Not Provided
 
Noninvasive and Continuous Hemoglobin Monitoring for Surgical Blood Management
Noninvasive and Continuous Hemoglobin Monitoring for Surgical Blood Management

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Surgery
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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
470
March 2014
September 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Richard Melseth 602-343-7458 rmelseth@sabm.org
Contact: Mazyar Javidroozi, MD, PhD 201-894-3917 mazyarjr@yahoo.com
United States
 
NCT01686659
NACHO
Yes
Society for the Advancement of Blood Management, Inc
Society for the Advancement of Blood Management, Inc
Not Provided
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
Society for the Advancement of Blood Management, Inc
August 2013

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