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

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.

Study Overview

• Status: Unknown
• Conditions: Surgery
• Intervention / Treatment: Device: Continuous Noninvasive Hemoglobin Monitoring

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: Interventional
• Enrollment (Anticipated): 470
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Richard Melseth; Phone Number: 602-343-7458; Email: rmelseth@sabm.org
• Study Contact Backup: Name: Mazyar Javidroozi, MD, PhD; Phone Number: 201-894-3917; Email: mazyarjr@yahoo.com

Study Locations

• France
  • Angers, France
    • Completed
    • CHU Angers
• Italy
  • MI
    • San Donato, MI, Italy
      • Completed
      • IRCCS Policlinico San Donato
• Japan
  • Hokkaido
    • Chuo-ku Sapporo, Hokkaido, Japan, 060-8543
      • Completed
      • Sapporo Medical University School of Medicine
• United States
  • California
    • Stanford, California, United States, 94305
      • Recruiting
      • Stanford University
      • Contact: Pedro P Tanaka, MD, PhD
      • Principal Investigator: Pedro P Tanaka, MD, PhD
  • New York
    • Bronx, New York, United States, 10467
      • Completed
      • Montefiore Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Completed
      • Duke University Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University Wexner Medical Center
      • Contact: Sergio Bergese, MD
  • Washington
    • Seattle, Washington, United States, 98122
      • Completed
      • Swedish Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of Intraoperative RBC Transfusion	Number of allogeneic RBC units transfused intraoperatively per patient	From the first surgical incision to the wound closure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative RBC Transfusion Rate	Occurrence of any allogeneic RBC transfusions intraoperatively	From the first surgical incision to the wound closure
Amount of Perioperative RBC Transfusion	Total number of allogeneic RBC units transfused perioperatively during hospital stay	From time of admission to the hospital to the time of discharge or death whichever sooner (an estimated average of 6 days)
Ischemic Events	Incidence of new (or worsening of pre-existing) ischemic events	From time of surgery to the time of discharge or death whichever sooner (an estimated average of 5 days)
Mortality	Any death occuring during surgery or within 30-day period following the surgery	From time of surgery to 30 days after the surgery
Length of Stay	Length of post-surgery hospital stay	From time of surgery to time of discharge from hospital (an estimated average of 5 days)

Collaborators and Investigators

• Sponsor: Society for the Advancement of Blood Management, Inc
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: August 29, 2012
• First Submitted That Met QC Criteria: September 12, 2012
• First Posted (Estimate): September 18, 2012

Study Record Updates

• Last Update Posted (Actual): April 23, 2018
• Last Update Submitted That Met QC Criteria: April 20, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Transfusion; SpHb; Continuous Hemoglobin Monitoring
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Chrysarobin
• Other Study ID Numbers: NACHO