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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SpHb Arm | Experimental | 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 |
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| Control Arm | No Intervention | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of Intraoperative RBC Transfusion | Number of allogeneic RBC units transfused intraoperatively per patient | From the first surgical incision to the wound closure |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative RBC Transfusion Rate | Occurrence of any allogeneic RBC transfusions intraoperatively | From the first surgical incision to the wound closure |
| Amount of Perioperative RBC Transfusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Richard Melseth | Contact | 602-343-7458 | rmelseth@sabm.org | |
| Mazyar Javidroozi, MD, PhD | Contact | 201-894-3917 | mazyarjr@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Aryeh Shander, MD | Englewood Hospital & Medical Center | Principal Investigator |
| Mazyar Javidroozi, MD, PhD | Englewood Hospital & Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Recruiting | Stanford | California | 94305 | United States |
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|
Total number of allogeneic RBC units transfused perioperatively during hospital stay
| 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 | 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 | From time of surgery to 30 days after the surgery |
| Length of Stay | Length of post-surgery hospital stay | From time of surgery to time of discharge from hospital (an estimated average of 5 days) |
| Aryeh Shander, MD |
| Englewood Hospital & Medical Center |
| Study Chair |
| Montefiore Medical Center | Completed | The Bronx | New York | 10467 | United States |
| Duke University Medical Center | Completed | Durham | North Carolina | 27710 | United States |
| The Ohio State University Wexner Medical Center | Recruiting | Columbus | Ohio | 43210 | United States |
|
| Swedish Medical Center | Completed | Seattle | Washington | 98122 | United States |
| CHU Angers | Completed | Angers | France |
| IRCCS Policlinico San Donato | Completed | San Donato | MI | Italy |
| Sapporo Medical University School of Medicine | Completed | Chuo-ku Sapporo | Hokkaido | 060-8543 | Japan |