Surgical Blood Management Using Noninvasive and Continuous Hemoglobin Monitoring(NACHO)
Recruitment status was: Not yet recruiting
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Noninvasive and Continuous Hemoglobin Monitoring for Surgical Blood Management (NACHO) - Matched-pair Cluster-randomized Controlled Trial|
- Number of allogeneic Red Blood Cells (RBC) units transfused intraoperatively [ Time Frame: perioperative period untill the end of surgery ] [ Designated as safety issue: No ]
- Hospital stay treatment - Occurrence of any allogeneic RBC transfusions intraoperatively [ Time Frame: From end of surgery until 30 days after surgery ] [ Designated as safety issue: No ]
- Hospital stay treatment - Total number of allogeneic RBC units transfused perioperatively during hospital stay [ Time Frame: From end of surgery until 30 days after surgery ] [ Designated as safety issue: No ]
- Hospital stay treatment - Incidence of new (or worsening of pre-existing) ischemic events [ Time Frame: From end of surgery until 30 days after surgery ] [ Designated as safety issue: No ]
- Hospital stay treatment - 30-day mortality [ Time Frame: From end of surgery until 30 days after surgery ] [ Designated as safety issue: No ]
- Hospital stay treatment - Length of post-surgery hospital stay [ Time Frame: From end of surgery until 30 days after surgery ] [ Designated as safety issue: No ]
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||January 2014|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Anesthesiologists without access to data from a continuous noninvasive hemoglobin monitoring device during surgery.
Anesthesiologists with access to data from a continuous noninvasive hemoglobin monitoring device during surgery.
Blood transfusions are associated with various risks including viral infections, delayed wound healing, transfusion related acute lung injury and cardiovascular complications. Despite limitations, and ongoing efforts to identify and validate other more-physiologically-relevant "triggers" for blood transfusions, hemoglobin-based transfusion triggers are still commonly used in practice, as well as in all currently available transfusion guidelines, alone, or in combination with other parameters. In the operating room the anesthesiologist has to withdraw blood from the patient and send it to the lab or the blood gas machine to achieve hemoglobin levels. It may be suggested that the ability to continuously monitor hemoglobin levels may help physicians to take more appropriate transfusion decisions; i.e, the physicians will either identify critical decreases in hemoglobin levels earlier and respond appropriately or avoid over-transfusing when hemoglobin levels have not decreased yet. Accordingly, monitors of hemoglobin levels are used in the operating theatre in many centers, although their blood-conserving effect has not been proven yet.
We believe that the transfusion decision making algorithm in the operating room relies less heavily on "on spot" measures of hemoglobin levels but rather on patient's comorbidities, expected additional bleeding according to the surgery and the surgeon, the course of the operation (the operating field is "open" and thus surgeons can tell if it is oozing or frank bleeding, if they can control bleeding promptly or not etc..), hemodynamic data available from the different invasive and non-invasive monitors, pressure from the surgeon, etc. It is therefore suggested that continuous monitoring of hemoglobin levels may be less relevant in this environment.
- The primary hypothesis is that continuous noninvasive hemoglobin monitoring will not reduce the number of blood 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 not be earlier warning of critical drops in hemoglobin, resulting in less frequent complications compared with patients who are not being monitored with continuous noninvasive hemoglobin.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01753960
|Tel-Aviv Sourasky Medical Center|
|Tel-Aviv, Israel, 64239|
|Principal Investigator:||Idit Matot, professor||Tel-Aviv Sourasky Medical Center|