Noninvasive and Continuous Hemoglobin Monitoring for Surgical Blood Management

NCT ID: NCT01686659

Last Updated: 2018-04-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 470 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2019-06-30

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.

Conditions

Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Continuous Noninvasive Hemoglobin Monitoring

Intervention Type: 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

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

SpHb; Radical-7; Radical 7 Pulse CO-Oximeter

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Society for the Advancement of Blood Management, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aryeh Shander, MD

Role: PRINCIPAL_INVESTIGATOR

Englewood Hospital & Medical Center

Mazyar Javidroozi, MD, PhD

Role: STUDY_DIRECTOR

Englewood Hospital & Medical Center

Aryeh Shander, MD

Role: STUDY_CHAIR

Englewood Hospital & Medical Center

Locations

Stanford University

Stanford, California, United States

Site Status: RECRUITING

Montefiore Medical Center

The Bronx, New York, United States

Site Status: COMPLETED

Duke University Medical Center

Durham, North Carolina, United States

Site Status: COMPLETED

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Site Status: RECRUITING

Swedish Medical Center

Seattle, Washington, United States

Site Status: COMPLETED

CHU Angers

Angers, , France

Site Status: COMPLETED

IRCCS Policlinico San Donato

San Donato, MI, Italy

Site Status: COMPLETED

Sapporo Medical University School of Medicine

Chuo-ku Sapporo, Hokkaido, Japan

Site Status: COMPLETED

Countries

United States; France; Italy; Japan

Central Contacts

Richard Melseth

Role: CONTACT

rmelseth@sabm.org

602-343-7458

Mazyar Javidroozi, MD, PhD

Role: CONTACT

mazyarjr@yahoo.com

201-894-3917

Facility Contacts

Pedro P Tanaka, MD, PhD

Role: primary

Sergio Bergese, MD

Role: primary

Other Identifiers

NACHO

Identifier Type: -

Identifier Source: org_study_id