Impact of Intraoperative Cell Salvage
- Conditions
- Peripartum Anemia
- Interventions
- Procedure: Intraoperative cellular salvage
- Registration Number
- NCT06240117
- Lead Sponsor
- Icahn School of Medicine at Mount Sinai
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 12
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard of care with intraoperative cell salvage Intraoperative cellular salvage Participants for elective surgery with anemia randomized to standard of care with intraoperative cell salvage.
- Primary Outcome Measures
Name Time Method The difference in postoperative hemoglobin at 48hrs compared to preoperative baseline Baseline and 48 hours postoperatively The difference in postoperative hemoglobin at 48hrs
Length of hospital stay at hospital discharge, likely within 120 hours from admission Length of hospital stay
Total blood volume transfused at hospital discharge, likely within 120 hours from admission Total blood volume transfused
Number of participants requiring allogeneic blood product transfusions at hospital discharge, likely within 120 hours from admission Need of allogeneic blood product transfusions
Quantity of allogeneic blood product transfusion in number of packed red blood cells transfused at hospital discharge, likely within 120 hours from admission Quantity of allogeneic blood product transfusion
- Secondary Outcome Measures
Name Time Method Anemia-Fatigue Scale (FACIT-F) Score at 48 hours postpartum The anemia-fatigue scale (FACIT-F) is a 40-item measure that assesses self-reported fatigue and its impact upon daily activities and function. Each item is measured on a Likert scale which ranges from 1-5. The overall score ranges from 0-160, a higher score indicates greater quality of life.
Number of participants being administered uterotonics within 30 minutes of the end of the surgical procedure (approximately 2 hours) Uterotonic use is documented by the anesthesiologist when given intraoperatively. They include oxytocin, misoprostol, methylergonovine and carboprost.
APGAR Scores at 5 minutes post-delivery APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low.
APGAR scores will be obtained at 5 minutes post-delivery.The Edinburgh Postnatal Depression Scale (EPDS) Score Up to 6 weeks postpartum The Edinburgh Postnatal Depression Scale (EPDS) is a short 10-item self-report questionnaire designed to identify mothers at risk for prenatal and postnatal depression will be performed at 6 weeks postpartum. Scores are between 0 and 30, with scores 13 and above indicating depressive illness, or a high risk of developing a depressive disorder.
Number of participants admitted to intensive care unit (ICU) Until hospital discharge, likely within 120 hours from admission When a higher level of care is needed that which can be provided on the post-operative labor and delivery floor, intensive care unit (ICU) admission may be required. The number of participants requiring ICU admission will be recorded.
The timing for intensive care unit (ICU) Until hospital discharge, likely within 120 hours from admission When a higher level of care is needed that that which can be provided on the post-operative labor and delivery floor, intensive care unit (ICU) admission may be required. The timing for ICU admission will be recorded.
Quantitative blood loss within 30 minutes of the end of the surgical procedure (approximately 2 hours) The quantitative blood loss is obtained from the measured blood lost and accumulated into the measuring devices such as suction canisters and cell saver machine available in the operating room.
The Obstetric Quality of Recovery-10 (OBSQOR-10) Score at 48 hours postpartum The Obstetric Quality of Recovery-10 patient-reported outcome measure (OBSQOR-10) at 48 hours postpartum is a validated tool for assessing the quality of postpartum recovery. Consists of 10 questions with a scale that ranges from 1-10.
Amount of postoperative blood product transfusion Until hospital discharge, likely within 120 hours from admission Blood products may be needed postoperatively depending on patient symptoms and laboratory values. The amount of postoperative blood product transfusion will be recorded. Possible blood products include packed red blood cells, platelets, fresh frozen plasma and cryoprecipitate. Will be reported as number of units.
Time to first dosage of pressors Until hospital discharge, likely within 120 hours from admission When low blood pressure is measured postoperatively, pressors may be needed for hemodynamic stability. Possible blood pressors used postoperatively include phenylephrine, ephedrine, norepinephrine and epinephrine. The timing will be recorded.
Use of postoperative uterine compression devices Until hospital discharge, likely within 120 hours from admission In cases of postoperative bleeding, uterine compression devices may be needed. The use will be recorded.
Timing of postoperative uterine compression devices Until hospital discharge, likely within 120 hours from admission In cases of postoperative bleeding, uterine compression devices may be needed. The timing will be recorded.
Number of participants receiving postoperative intravenous iron Until hospital discharge, likely within 120 hours from admission Intravenous iron is used in some cases of postoperative anemia. The number of participants receiving postoperative intravenous iron will be recorded.
Reason for intensive care unit (ICU) Until hospital discharge, likely within 120 hours from admission When a higher level of care is needed that that which can be provided on the post-operative labor and delivery floor, intensive care unit (ICU) admission may be required. The reason for ICU admission will be recorded.
Use of postoperative blood product transfusion Until hospital discharge, likely within 120 hours from admission Blood products may be needed postoperatively depending on patient symptoms and laboratory values. The timing of postoperative blood product transfusion will be recorded in relation to the end of procedure time. Possible blood products include packed red blood cells, platelets, fresh frozen plasma and cryoprecipitate.
Trial Locations
- Locations (1)
The Mount Sinai Hospital
🇺🇸New York, New York, United States