Using cell salvage during cesarean sections to manage anemia
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
NA · Icahn School of Medicine at Mount Sinai · NCT06240117
This study tests if using a method to collect and reuse blood during cesarean sections helps women with anemia have better recovery and less need for blood transfusions.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Icahn School of Medicine at Mount Sinai (other) |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06240117 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of intraoperative cell salvage on women undergoing elective cesarean sections who have pre-procedural anemia. Participants will be randomized into two groups: one receiving standard care with cell salvage and the other receiving standard care without it. The primary focus is to compare postoperative hemoglobin levels, the need for blood transfusions, and length of hospital stay between the two groups. Secondary endpoints will assess maternal postpartum stability and clinical parameters such as blood loss and the need for additional medications.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-55 presenting for elective cesarean sections with hemoglobin levels of 11 mg/dL or lower.
Not a fit: Patients who refuse blood product administration or intraoperative blood salvage will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce the need for blood transfusions and improve recovery outcomes for women with anemia undergoing cesarean sections.
How similar studies have performed: Other studies have shown promising results with intraoperative cell salvage in various surgical settings, suggesting potential benefits in this context as well.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New York, New York
- The Mount Sinai Hospital — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Daniel Katz, MD — MOUNT SINAI HOSPITAL
- Study coordinator: Gabriela Hernandez Meza, MD, PhD
- Email: Gabriela.hernandezmeza@mountsinai.org
- Phone: 814-769-1104
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Peripartum Anemia