Noninvasive and Continuous Hemoglobin Monitoring for Surgical Blood Management

NCT01686659 | Unknown DMC

• 1 other identifier: NACHO
• Study Type: interventional
• Target: 470
• Locations: 4 countries
• Sites: 8

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.

Conditions

Surgery

Keywords

Transfusion; Continuous Hemoglobin Monitoring; SpHb

Outcome Measures

Primary Outcomes (1)

• Amount of Intraoperative RBC Transfusion

  Number of allogeneic RBC units transfused intraoperatively per patient

  From the first surgical incision to the wound closure

Secondary Outcomes (5)

• Intraoperative RBC Transfusion Rate

  From the first surgical incision to the wound closure

• Amount of Perioperative RBC Transfusion

  From time of admission to the hospital to the time of discharge or death whichever sooner (an estimated average of 6 days)

• Ischemic Events

  From time of surgery to the time of discharge or death whichever sooner (an estimated average of 5 days)

• Mortality

  From time of surgery to 30 days after the surgery

• Length of Stay

  From time of surgery to time of discharge from hospital (an estimated average of 5 days)

Study Arms (2)

SpHb Arm

EXPERIMENTAL

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

Control Arm

NO INTERVENTION

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

Interventions

Continuous Noninvasive Hemoglobin Monitoring DEVICE

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

Also known as: SpHb, Radical-7, Radical 7 Pulse CO-Oximeter

SpHb Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Society for the Advancement of Blood Management, Inc: lead

Study Sites (8)

Stanford University

Stanford, California, 94305, United States

RECRUITING

Montefiore Medical Center

The Bronx, New York, 10467, United States

COMPLETED

Duke University Medical Center

Durham, North Carolina, 27710, United States

COMPLETED

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

Swedish Medical Center

Seattle, Washington, 98122, United States

COMPLETED

CHU Angers

Angers, France

COMPLETED

IRCCS Policlinico San Donato

San Donato, MI, Italy

COMPLETED

Sapporo Medical University School of Medicine

Chuo-ku Sapporo, Hokkaido, 060-8543, Japan

COMPLETED

Study Officials

• Aryeh Shander, MD

  Englewood Hospital & Medical Center

  PRINCIPAL INVESTIGATOR

• Mazyar Javidroozi, MD, PhD

  Englewood Hospital & Medical Center

  STUDY DIRECTOR

• Aryeh Shander, MD

  Englewood Hospital & Medical Center

  STUDY CHAIR

Central Study Contacts

Richard Melseth

CONTACT

602-343-7458; rmelseth@sabm.org

Mazyar Javidroozi, MD, PhD

CONTACT

201-894-3917; mazyarjr@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2012
• First Posted: September 18, 2012
• Study Start: September 1, 2012
• Primary Completion: December 1, 2018
• Study Completion: June 1, 2019
• Last Updated: April 23, 2018

Record last verified: 2018-04

Locations

FR (1); IT (1); US (5); JP (1)