Clinical trial NCT06240117: Impact of Intraoperative Cell Salvage
Official title: Impact of Intraoperative Cell Salvage on Maternal Hemoglobin, Need for Allogeneic Blood Transfusion and Recovery Time in Women Presenting With Preoperative Moderate Anemia Undergoing Elective Cesarian Section
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peripartum Anemia
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2024-02-02
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: The difference in postoperative hemoglobin at 48hrs compared to preoperative baseline
timeFrame: Baseline and 48 hours postoperatively
measure: Number of participants requiring allogeneic blood product transfusions
timeFrame: at hospital discharge, likely within 120 hours from admission
measure: Quantity of allogeneic blood product transfusion in number of packed red blood cells transfused
timeFrame: at hospital discharge, likely within 120 hours from admission
measure: Total blood volume transfused
timeFrame: at hospital discharge, likely within 120 hours from admission
measure: Length of hospital stay
timeFrame: at hospital discharge, likely within 120 hours from admission
Secondary outcomes:
measure: Quantitative blood loss
timeFrame: within 30 minutes of the end of the surgical procedure (approximately 2 hours)
measure: Number of participants being administered uterotonics
timeFrame: within 30 minutes of the end of the surgical procedure (approximately 2 hours)
measure: Time to first dosage of pressors
timeFrame: Until hospital discharge, likely within 120 hours from admission
measure: APGAR Scores
timeFrame: at 1 minute post-delivery
measure: APGAR Scores
timeFrame: at 5 minutes post-delivery
measure: Anemia-Fatigue Scale (FACIT-F) Score
timeFrame: at 24 hours postpartum
measure: Anemia-Fatigue Scale (FACIT-F) Score
timeFrame: at 48 hours postpartum
measure: The Obstetric Quality of Recovery-10 (OBSQOR-10) Score
timeFrame: at 24 hours postpartum
measure: The Obstetric Quality of Recovery-10 (OBSQOR-10) Score
timeFrame: at 48 hours postpartum
measure: The Edinburgh Postnatal Depression Scale (EPDS) Score
timeFrame: Up to 6 weeks postpartum
measure: Use of postoperative uterine compression devices
timeFrame: Until hospital discharge, likely within 120 hours from admission
measure: Timing of postoperative uterine compression devices
timeFrame: Until hospital discharge, likely within 120 hours from admission
measure: Use of postoperative blood product transfusion
timeFrame: Until hospital discharge, likely within 120 hours from admission
measure: Amount of postoperative blood product transfusion
timeFrame: Until hospital discharge, likely within 120 hours from admission
measure: Number of participants receiving postoperative intravenous iron
timeFrame: Until hospital discharge, likely within 120 hours from admission
measure: Number of participants admitted to intensive care unit (ICU)
timeFrame: Until hospital discharge, likely within 120 hours from admission
measure: The timing for intensive care unit (ICU)
timeFrame: Until hospital discharge, likely within 120 hours from admission
measure: Reason for intensive care unit (ICU)
timeFrame: Until hospital discharge, likely within 120 hours from admission
Other outcomes:
Locations:
city: New York
country: United States
facility: The Mount Sinai Hospital
state: New York
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Daniel Katz, MD
role: PRINCIPAL_INVESTIGATOR
References: