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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores intraoperative cell salvage, a technique to collect and reuse a person's own blood during surgery, to manage anemia in women undergoing planned C-sections. It compares two groups: one receives standard care with this blood-saving technique, and the other receives standard care without it. The goal is to determine if this technique reduces the need for blood transfusions and shortens hospital stays. Women scheduled for a C-section, who have anemia and are open to receiving blood products during surgery, might be suitable candidates for the trial. As an unphased study, this trial provides a unique opportunity to contribute to medical knowledge and potentially improve surgical outcomes for future patients.

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 prior data suggests that intraoperative cell salvage is safe for postpartum anemia?

Research has shown that intraoperative cell salvage (ICS) during cesarean sections is safe. Studies have found that ICS does not lead to serious issues such as amniotic fluid embolism, infections, low blood pressure, or allergic reactions. ICS reduces the need for additional blood transfusions and shortens hospital stays without causing harm. Overall, ICS serves as a reliable option, especially for patients at high risk of heavy bleeding after childbirth. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about intraoperative cell salvage for postpartum anemia because it offers a novel way to manage blood loss during cesarean sections. Unlike the standard practice of blood transfusions, this method recycles the patient's own blood lost during surgery, reducing the need for donor blood. This approach not only minimizes the risk of transfusion-related complications but also eases the demand on blood banks, offering a safer and more sustainable solution for managing anemia after childbirth.

What evidence suggests that intraoperative cell salvage is effective for postpartum anemia?

Research has shown that intraoperative cell salvage (ICS) during cesarean deliveries can significantly reduce the need for donated blood transfusions. One study found that 66% of women using ICS did not require additional blood, even with high blood loss. Other studies indicate that ICS helps prevent postpartum anemia by boosting the mother's hemoglobin levels. Additionally, using ICS during cesareans has lowered the risk of complications and shortened hospital stays. In this trial, participants will be randomized to receive either standard care with ICS or standard care without ICS. Overall, these findings suggest that ICS could be a valuable option for managing blood loss during cesarean sections. ^{3 6 7 8 9}

Who Is on the Research Team?

Daniel Katz, MD

Principal Investigator

MOUNT SINAI HOSPITAL

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5771819/

Cost-Effectiveness Analysis of Intraoperative Cell Salvage ... Intraoperative cell salvage in obstetrics reduces the need for allogeneic blood transfusion and mitigates postpartum anemia after cesarean delivery.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12087592/

Evaluating the Safety and Efficacy of Intraoperative Cell ... These findings demonstrate that IOCS safely decreases dependence on allogeneic blood products in PAS management, particularly benefiting high-risk patients.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2589933323003993

Use of cell salvage at the time of cesarean delivery Use of cell salvage during cesarean delivery reduced the overall need for allogeneic blood transfusion without increasing the risk of complications.

4. cureus.com cureus.com/articles/429398-cell-salvage-in-the-management-of-postpartum-hemorrhage-a-comprehensive-review-of-the-current-literature

Cell Salvage in the Management of Postpartum Hemorrhage Reported benefits include improved maternal hemoglobin, reduced transfusion-related complications, and shorter hospital stay. However, not all ...

5. withpower.com withpower.com/trial/phase-anemia-1-2024-59f14

Intraoperative Cell Salvage for Postpartum Anemia ICS significantly reduced the need for allogeneic blood transfusions, as 66% of women did not require additional blood transfusions despite high estimated blood ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9589269/

Intraoperative cell salvage as an effective intervention for ... There was no adverse effect such as amniotic fluid embolism, infection, hypotension, or allergy following ICS treatment. PPH is a leading cause of maternal ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36300123/

Intraoperative cell salvage as an effective intervention for ... ICS is an effective and safe intervention for patients with a high risk of PPH during elective or emergency Cesarean section.

8. bmcanesthesiol.biomedcentral.com bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-025-03327-0

Effect of intraoperative cell salvage on postoperative blood ... This study aimed to analyze the postoperative blood transfusion demand and safety of intraoperative cell salvage (ICS) without leukocyte ...

9. dovepress.com dovepress.com/evaluating-the-safety-and-efficacy-of-intraoperative-cell-salvage-in-c-peer-reviewed-fulltext-article-IJWH

Evaluating the Safety and Efficacy of Intraoperative Cell ... These findings demonstrate that IOCS safely decreases dependence on allogeneic blood products in PAS management, particularly benefiting high-risk patients.