Impact of Intraoperative Cell Salvage

Mount Sinai Health System

Status: Terminated

Conditions: Peripartum Anemia

Treatments: Procedure: Intraoperative cellular salvage

Study type: Interventional

Funder types: Other

Identifiers

NCT06240117

STUDY-23-01380

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Standard of care with intraoperative cell salvage

Experimental group

Description:

Participants for elective surgery with anemia randomized to standard of care with intraoperative cell salvage.

Treatment:

Procedure: Intraoperative cellular salvage

Standard of care without intraoperative cell salvage

No Intervention group

Description:

Standard of care for cesarean sections as per the policy of the anesthesiology department.