Noninvasive and Continuous Hemoglobin Monitoring for Surgical Blood Management



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:4/25/2018
Start Date:September 2012
End Date:June 2019
Contact:Richard Melseth
Email:rmelseth@sabm.org
Phone:602-343-7458

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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.

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
We found this trial at
6
sites
3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Principal Investigator: Elise Delphin, MD
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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Angers,
Principal Investigator: Sigismond Lasocki, MD
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Angers,
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410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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Columbus, OH
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Nicole Guinn, MD
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Principal Investigator: Lori Heller, MD
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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Seattle, WA
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450 Serra Mall
Stanford, California 94305
(650) 723-2300
Principal Investigator: Pedro P Tanaka, MD, PhD
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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Stanford, CA
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