Intraoperative Cell Salvage for Postpartum Anemia

Overseen By Gabriela Hernandez Meza, MD, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Refusal of blood products, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Approximately 1 day

12 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment Intraoperative Cell Salvage for postpartum anemia?

Research suggests that intraoperative cell salvage can reduce the need for donor blood transfusions during cesarean deliveries, which may help manage postpartum anemia. It has been shown to be effective in reducing the use of donor blood in various surgeries, including obstetric and cardiac procedures, and is considered safe when used with a special filter to remove unwanted cells. ^{1 2 3 4 5}

Is intraoperative cell salvage safe for humans?

Intraoperative cell salvage is generally considered safe and is used to reduce the need for donor blood transfusions, which can have complications. It has been shown to be safe in surgeries with significant blood loss, including cardiac and orthopedic surgeries, and appears safe in obstetrics with additional filtering, though more research is needed for definitive guidance. ^{1 4 5 6 7}

How is the treatment Intraoperative Cell Salvage unique for postpartum anemia?

Intraoperative Cell Salvage is unique for postpartum anemia because it involves collecting and reusing the patient's own blood lost during surgery, reducing the need for donor blood transfusions and their associated risks, such as infections or immune reactions. ^{1 2 4 5 8}

Research Team

Daniel Katz, MD

Principal Investigator

MOUNT SINAI HOSPITAL

Eligibility Criteria

This trial is for women aged 18-55 who are scheduled for an elective cesarean section and have a hemoglobin level of 10 mg/dL or less. They must be able to give informed consent. Women who refuse blood products or intraoperative blood salvage cannot participate.

Inclusion Criteria

I am a woman aged between 18 and 55.

I am scheduled for a planned C-section.

My hemoglobin level is 10 mg/dL or lower.

Exclusion Criteria

I refuse to receive blood transfusions.

I refuse to have my blood collected and reused during surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo elective cesarean section with or without intraoperative cell salvage

Approximately 1 day

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for postoperative hemoglobin levels, need for blood transfusions, and other clinical parameters

48 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments at 6 weeks postpartum

6 weeks

Treatment Details

Interventions

• Intraoperative Cellular Salvage

Trial Overview The study compares two approaches in patients with pre-procedural anemia undergoing cesarean sections: one group receives the standard care plus intraoperative cell salvage, while the other just gets standard care. The main goal is to see if there's a difference in post-op hemoglobin at 48 hours, transfusion needs, and hospital stay length.

Participant Groups

Group I: Standard of care with intraoperative cell salvage Experimental Treatment 1 Intervention

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

Group II: Standard of care without intraoperative cell salvage Active Control 1 Intervention

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

Intraoperative Cellular Salvage is already approved in European Union, United Kingdom, United States for the following indications:

Approved in European Union as Intraoperative Cell Salvage for:

• Elective cesarean section with anticipated significant blood loss
• Maternal hemorrhage
• Cardiac surgery
• Orthopedic surgery
• Vascular surgery

Approved in United Kingdom as Intraoperative Cell Salvage for:

• Maternal hemorrhage
• Cardiac surgery
• Orthopedic surgery
• Vascular surgery
• Emergency trauma surgery

Approved in United States as Intraoperative Cell Salvage for:

• Elective cesarean section with anticipated significant blood loss
• Cardiac surgery
• Orthopedic surgery
• Vascular surgery

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Findings from Research

The implementation of targeted intraoperative cell salvage during cesarean deliveries led to a significant reduction in the use of allogeneic packed red blood cells in the operating room, with a decrease of 0.7% in monthly transfusion rates.

There were no significant adverse events or changes in the rate of acute blood transfusion reactions associated with the use of intraoperative cell salvage, indicating that this method is safe for women undergoing cesarean delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Association of Targeted Cell Salvage Blood Transfusion During Cesarean Delivery With Allogeneic Packed Red Blood Cell Transfusions in a Maternity Hospital in China. Yan, H., Hu, LQ., Wu, Y., et al.[2019]

Intraoperative cell salvage (ICS) was used safely in 50 obstetric patients, primarily those with placenta previa, with no reported adverse events during the procedure.

ICS significantly reduced the need for allogeneic blood transfusions, as 66% of women did not require additional blood transfusions despite high estimated blood loss, indicating its potential effectiveness in managing severe hemorrhage during obstetric surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative red cell salvage during obstetric surgery in 50 Japanese women. Morikawa, M., Kuramoto, A., Nakayama, M., et al.[2016]

In a study involving 12 patients undergoing metastatic spine tumor surgery, the use of intraoperative cell salvage combined with leucocyte depletion filters effectively removed tumor cells from salvaged blood, with 8 out of 11 patients showing no detectable tumor cells after filtration.

The findings indicate that the quantity of tumor cells in the filtered salvaged blood was significantly lower than in the patient's circulation, supporting the safety of using this method for blood transfusion during oncological surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flow cytometric evaluation of the safety of intraoperative salvaged blood filtered with leucocyte depletion filter in spine tumour surgery. Kumar, N., Lam, R., Zaw, AS., et al.[2014]

Routine intraoperative cell salvage during lower segment caesarean sections significantly improved maternal outcomes, leading to higher post-operative hemoglobin levels and fewer cases of anemia compared to selective cell salvage practices.

The mandated use of intraoperative cell salvage also resulted in a significant reduction in the need for post-partum iron infusions, indicating its effectiveness in managing blood loss during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between routine cell salvage use for lower segment caesarean section and post-operative iron infusion and anemia. Fox, TP., Timpani, E., Green, A., et al.[2023]

Intraoperative cell salvage and autologous blood transfusion are effective methods for reducing the need for allogeneic blood transfusions, which can lead to serious complications such as increased risk of infection and mortality, especially in elective surgeries like cardiac and orthopedic procedures.

While cell salvage is generally safe, prolonged use may lead to dilution of clotting factors, necessitating regular monitoring; it is recommended for surgeries with expected significant blood loss or for patients who refuse allogeneic blood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cell salvage as part of a blood conservation strategy in anaesthesia. Ashworth, A., Klein, AA.[2022]

In a study of 79 patients undergoing abdominal aortic surgery, intraoperative cell salvage (ICS) was found to be a safe procedure with no major complications reported.

ICS significantly reduced the need for allogenic blood transfusions, with 57% of all patients and 66% of those undergoing elective repairs not requiring supplemental blood, highlighting its efficacy in managing blood loss during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transfusion requirements and outcomes in patients undergoing abdominal aortic surgery using intra-operative cell salvage. Healy, CF., Doyle, M., Egan, B., et al.[2019]

In a study involving 43,198 patients over 11 years, intraoperative cell salvage (ICS) was found to have a very low rate of patient-related adverse events (AEs), with only 0 to 2 AEs reported per 33,351 reinfusion cases (0%-0.006%).

The majority of comments regarding ICS procedures were minor and did not lead to significant complications, indicating that ICS is a safe practice, although two potential AEs were noted, both of which were resolved without lasting issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Very low rate of patient-related adverse events associated with the use of intraoperative cell salvage. DeAndrade, D., Waters, JH., Triulzi, DJ., et al.[2022]

Intraoperative cell salvage is beneficial in revision hip surgeries, particularly for patients undergoing two-component revisions, as they had higher transfusion volumes and more cases utilizing cell salvage.

Patients who needed postoperative blood transfusions were generally older, had lower preoperative hemoglobin levels, and were less likely to have received tranexamic acid, indicating these factors should be considered when deciding on the use of cell salvage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimising the use of cell salvage in revision hip arthroplasty. Walker, LC., Halliwell, E., Veitch, SW.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

The Association of Targeted Cell Salvage Blood Transfusion During Cesarean Delivery With Allogeneic Packed Red Blood Cell Transfusions in a Maternity Hospital in China. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Intraoperative red cell salvage during obstetric surgery in 50 Japanese women. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Flow cytometric evaluation of the safety of intraoperative salvaged blood filtered with leucocyte depletion filter in spine tumour surgery. [2014]

4. Germany pubmed.ncbi.nlm.nih.gov

Association between routine cell salvage use for lower segment caesarean section and post-operative iron infusion and anemia. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Cell salvage as part of a blood conservation strategy in anaesthesia. [2022]

6. Ireland pubmed.ncbi.nlm.nih.gov

Transfusion requirements and outcomes in patients undergoing abdominal aortic surgery using intra-operative cell salvage. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Very low rate of patient-related adverse events associated with the use of intraoperative cell salvage. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Optimising the use of cell salvage in revision hip arthroplasty. [2023]