Clinical trial NCT01686659: Noninvasive and Continuous Hemoglobin Monitoring for Surgical Blood Management
Official title: Noninvasive and Continuous Hemoglobin Monitoring for Surgical Blood Management
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Surgery
Keywords: Transfusion
Continuous Hemoglobin Monitoring
SpHb
Lead sponsor: Society for the Advancement of Blood Management, Inc
Sponsor class: INDUSTRY
First posted: 2012-09-18
Enrollment: 470
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Amount of Intraoperative RBC Transfusion
timeFrame: From the first surgical incision to the wound closure
Secondary outcomes:
measure: Intraoperative RBC Transfusion Rate
timeFrame: From the first surgical incision to the wound closure
measure: Amount of Perioperative RBC Transfusion
timeFrame: From time of admission to the hospital to the time of discharge or death whichever sooner (an estimated average of 6 days)
measure: Ischemic Events
timeFrame: From time of surgery to the time of discharge or death whichever sooner (an estimated average of 5 days)
measure: Mortality
timeFrame: From time of surgery to 30 days after the surgery
measure: Length of Stay
timeFrame: From time of surgery to time of discharge from hospital (an estimated average of 5 days)
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Angers
country: France
facility: CHU Angers
city: San Donato
country: Italy
facility: IRCCS Policlinico San Donato
state: MI
city: Chuo-ku Sapporo
country: Japan
facility: Sapporo Medical University School of Medicine
state: Hokkaido
Study officials:
affiliation: Englewood Hospital & Medical Center
name: Aryeh Shander, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Englewood Hospital & Medical Center
name: Mazyar Javidroozi, MD, PhD
role: STUDY_DIRECTOR
affiliation: Englewood Hospital & Medical Center
name: Aryeh Shander, MD
role: STUDY_CHAIR
References: