An interventional study of Continuous Noninvasive Hemoglobin Monitoring in Surgery, sponsored by Society for the Advancement of Blood Management, Inc. Status unknown at 8 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-23.
Sponsored by Society for the Advancement of Blood Management, Inc · Not applicable, Interventional, and Diagnostic
This is a multi-center cluster-randomized trial with the following Specific Aims:
Accordingly, the study hypotheses are defined as follows:
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.
This is the only study on the registry with Society for the Advancement of Blood Management, Inc as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
Amount of Intraoperative RBC Transfusion
Number of allogeneic RBC units transfused intraoperatively per patient
Time frame: From the first surgical incision to the wound closure
Intraoperative RBC Transfusion Rate
Occurrence of any allogeneic RBC transfusions intraoperatively
Time frame: From the first surgical incision to the wound closure
Amount of Perioperative RBC Transfusion
Total number of allogeneic RBC units transfused perioperatively during hospital stay
Time frame: From time of admission to the hospital to the time of discharge or death whichever sooner (an estimated average of 6 days)
Ischemic Events
Incidence of new (or worsening of pre-existing) ischemic events
Time frame: From time of surgery to the time of discharge or death whichever sooner (an estimated average of 5 days)
Mortality
Any death occuring during surgery or within 30-day period following the surgery
Time frame: From time of surgery to 30 days after the surgery
Length of Stay
Length of post-surgery hospital stay
Time frame: From time of surgery to time of discharge from hospital (an estimated average of 5 days)
This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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