NCT06240117|Terminated
Study Stopped
Under enrollment
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Under enrollment
Sponsor study identifier
interventional
20
1 country
1
Study Start
March 11, 2024
Actual (reported)Primary Completion
June 25, 2025
Actual (reported)Study Completion
June 25, 2025
Actual (reported)Patients presenting for elective cesarean section will be screened for pre-procedural anemia. If the potential subject meets the selection criteria they will be presented with the option of participating in the study. Once consented the participant is randomized by envelope. The two groups studied are: standard of care with intraoperative cell salvage and standard of care without cell salvage. If the participant is randomized to the cell salvage group, the study team will notify the anesthesia and obstetrics (OB) team and will set up the cell salvage system per protocol. The primary end point is to determine the difference in postoperative hemoglobin at 48hrs, need and quantity of allogeneic blood product transfusion, length of hospital stay between the two groups studied. The secondary endpoints Investigate the impact of using IOCS on clinical parameters associated with maternal postpartum stability and well being and include estimation of blood loss, need for pressors, uterotonics, return to the operating room, uterine compression devices, ICU admission, postoperative blood product transfusion, IV iron supplementation, blood chemistry, coagulation parameters, oliguria, diagnosis of acute kidney injury, postoperative dialysis, acute respiratory distress syndrome, pulmonary edema, pneumonia, deep vein thrombosis, pulmonary embolism, oxygen requirement, new arrythmias APGAR scores, anemia fatigue scale at 24hr and 48 hrs, OBSQOR10 score 24 hours and 48 hours postpartum and 6 week postpartum EPDS score.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 25, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 25, 2024
Actual (reported)February 2, 2024
Actual (reported)March 11, 2024
Actual (reported)June 25, 2025
Actual (reported)June 25, 2025
Actual (reported)The difference in postoperative hemoglobin at 48hrs compared to preoperative baseline
The difference in postoperative hemoglobin at 48hrs
Baseline and 48 hours postoperatively
Number of participants requiring allogeneic blood product transfusions
Need of allogeneic blood product transfusions
at hospital discharge, likely within 120 hours from admission
Quantity of allogeneic blood product transfusion in number of packed red blood cells transfused
Quantity of allogeneic blood product transfusion
at hospital discharge, likely within 120 hours from admission
Total blood volume transfused
Total blood volume transfused
at hospital discharge, likely within 120 hours from admission
Length of hospital stay
Length of hospital stay
at hospital discharge, likely within 120 hours from admission
Quantitative blood loss
within 30 minutes of the end of the surgical procedure (approximately 2 hours)
Number of participants being administered uterotonics
within 30 minutes of the end of the surgical procedure (approximately 2 hours)
Time to first dosage of pressors
Until hospital discharge, likely within 120 hours from admission
APGAR Scores
at 1 minute post-delivery
APGAR Scores
at 5 minutes post-delivery
Participants for elective surgery with anemia randomized to standard of care with intraoperative cell salvage.
Standard of care for cesarean sections as per the policy of the anesthesiology department.
When the patient is randomized to this intervention the cell salvage machine will be set up for intraoperative use. The surgical team will collect blood from the surgical field into the cell salvage machine, which will process the blood for reinfusion. The volume of blood available for reinfusion is determined by the amount of blood lost which can be collected into the cell salvage system. The blood collected into the salvage system will be collected and processed per standard operating room procedure. At least 100mL of blood collected in the system are necessary for processing. If \>100mLs are collected, they will be processed and reinfused. The need for additional blood products and medications will be determined by the anesthesiology team based on the patient's hemodynamic status and will proceed per standard of care.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The Mount Sinai Hospital
New York, New York, 10029, United States
Daniel Katz, MD
MOUNT SINAI HOSPITAL
20 participants (actual enrollment reported by the registry).
First Submitted
January 25, 2024
First Posted
February 2, 2024
Study Start
March 11, 2024
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
June 25, 2025
Actual (reported)Study Completion
June 25, 2025
Actual (reported)Last Updated
July 2, 2025
Record last verified: 2025-06
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Source: ClinicalTrials.gov.
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