Impact of Intraoperative Cell Salvage

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

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.

Study Overview

• Status: Recruiting
• Conditions: Peripartum Anemia
• Intervention / Treatment: Procedure: Intraoperative cellular salvage

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gabriela Hernandez Meza, MD, PhD; Phone Number: 814-769-1104; Email: Gabriela.hernandezmeza@mountsinai.org
• Study Contact Backup: Name: Daniel Katz, MD; Phone Number: 212-241-7749; Email: daniel.katz@mountsinai.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • The Mount Sinai Hospital
      • Principal Investigator: Daniel Katz
      • Contact: Daniel Katz, MD; Phone Number: 212-241-7749; Email: daniel.katz@mountsinai.org
      • Contact: Gabriela Hernandez Meza, MD, PhD; Email: gabriela.hernandezmeza@mountsinai.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

• Women aged 18-55 years.
• Presenting for elective cesarean section.
• With hemoglobin less or equal to 10 mg/dL.
• Able to provide informed written consent.

Exclusion criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard of care with intraoperative cell salvage; Participants for elective surgery with anemia randomized to standard of care with intraoperative cell salvage.	Procedure: Intraoperative cellular salvage; 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.
No Intervention: Standard of care without intraoperative cell salvage; Standard of care for cesarean sections as per the policy of the anesthesiology department.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative blood loss	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.	within 30 minutes of the end of the surgical procedure (approximately 2 hours)
Number of participants being administered uterotonics	Uterotonic use is documented by the anesthesiologist when given intraoperatively. They include oxytocin, misoprostol, methylergonovine and carboprost.	within 30 minutes of the end of the surgical procedure (approximately 2 hours)
Time to first dosage of pressors	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.	Until hospital discharge, likely within 120 hours from admission
APGAR Scores	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 1 minute post-delivery.	at 1 minute post-delivery
APGAR Scores	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.	at 5 minutes post-delivery
Anemia-Fatigue Scale (FACIT-F) Score	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.	at 24 hours postpartum
Anemia-Fatigue Scale (FACIT-F) Score	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.	at 48 hours postpartum
The Obstetric Quality of Recovery-10 (OBSQOR-10) Score	The Obstetric Quality of Recovery-10 patient-reported outcome measure (OBSQOR-10) at 24 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.	at 24 hours postpartum
The Obstetric Quality of Recovery-10 (OBSQOR-10) Score	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.	at 48 hours postpartum
The Edinburgh Postnatal Depression Scale (EPDS) Score	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.	Up to 6 weeks postpartum
Use of postoperative uterine compression devices	In cases of postoperative bleeding, uterine compression devices may be needed. The use will be recorded.	Until hospital discharge, likely within 120 hours from admission
Timing of postoperative uterine compression devices	In cases of postoperative bleeding, uterine compression devices may be needed. The timing will be recorded.	Until hospital discharge, likely within 120 hours from admission
Use of postoperative blood product transfusion	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.	Until hospital discharge, likely within 120 hours from admission
Amount of postoperative blood product transfusion	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.	Until hospital discharge, likely within 120 hours from admission
Number of participants receiving postoperative intravenous iron	Intravenous iron is used in some cases of postoperative anemia. The number of participants receiving postoperative intravenous iron will be recorded.	Until hospital discharge, likely within 120 hours from admission
Number of participants admitted to intensive care unit (ICU)	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.	Until hospital discharge, likely within 120 hours from admission
The timing for intensive care unit (ICU)	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.	Until hospital discharge, likely within 120 hours from admission
Reason for intensive care unit (ICU)	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.	Until hospital discharge, likely within 120 hours from admission

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Daniel Katz, MD, Mount Sinai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: January 25, 2024
• First Submitted That Met QC Criteria: January 25, 2024
• First Posted (Actual): February 2, 2024

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia
• Other Study ID Numbers: STUDY-23-01380

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication.

IPD Sharing Access Criteria

Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose.

To achieve aims in the approved proposal. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at (Link to be included in the URL field below).

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No