Recruiting

Hemoglobin Monitoring

Sponsor:

Society for the Advancement of Blood Management, Inc

Code:

NCT01686659

Conditions

Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Continuous Noninvasive Hemoglobin Monitoring

Study Details

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

Study ID

NCT01686659

Start date

Sep, 2012

Status verified date

Apr, 2018

Completion date

Jun, 2019

Anticipated

Primary completion date

Dec, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

470 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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

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

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

Primary outcome measure

  • Amount of Intraoperative RBC Transfusion [ Time Frame: From the first surgical incision to the wound closure ]

Central Contacts and Locations

Central contacts

Richard Melseth

602-343-7458rmelseth@sabm.org

Mazyar Javidroozi, MD, PhD

201-894-3917mazyarjr@yahoo.com

Locations

Stanford University

Recruiting

Stanford, California, United States, 94305

Principal Investigator:

Pedro P Tanaka, MD, PhD

The Ohio State University Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43210

More Information

Sponsor

Society for the Advancement of Blood Management, Inc

Last update posted

Apr 23, 2018

Last verified

Apr, 2018

Keywords

  • Transfusion
  • Continuous Hemoglobin Monitoring
  • SpHb

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Society for the Advancement of Blood Management, Inc on 2018-04-23.