Impact of Intraoperative Cell Salvage

Stopped early · Not applicable

Conditions studied: Peripartum Anemia

In brief

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.

Key facts

Study ID

NCT06240117

Run by

Icahn School of Medicine at Mount Sinai

People needed

20

Starts

2024-03-11

Expected to finish

2025-06-25

Last updated by the study team

2025-07-02

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women aged 18-55 years.
• Presenting for elective cesarean section.
• With hemoglobin less or equal to 11 mg/dL.
• Able to provide informed written consent.

You may not qualify if…

• Refusal of blood product administration.
• Refusal of intraoperative blood salvage.

Where it is running

• The Mount Sinai Hospital — New York, New York, United States

Full record on ClinicalTrials.gov

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