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Procedure

Standard of care with intraoperative cell salvage for Postpartum Anemia

N/A

Recruiting

Led By Daniel Katz, MD

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Women aged 18-55 years

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 5 minutes post-delivery

Awards & highlights

Study Summary

This trial will study the effects of using a cell salvage system during cesarean sections. Patients will be screened for anemia and those meeting the criteria will be asked to participate. They will be randomly

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects aren't listed for this procedure, potential risks may include reactions related to transfusions such as fever, allergic reactions, lung injury from donated blood cells, or infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a woman aged between 18 and 55.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 5 minutes post-delivery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 5 minutes post-delivery

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 5 minutes post-delivery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Length of hospital stay

Number of participants requiring allogeneic blood product transfusions

Quantity of allogeneic blood product transfusion in number of packed red blood cells transfused

+2 more

Secondary outcome measures

APGAR Scores

Amount of postoperative blood product transfusion

Anemia-Fatigue Scale (FACIT-F) Score

+12 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Standard of care with intraoperative cell salvageExperimental Treatment1 Intervention

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

Group II: Standard of care without intraoperative cell salvageActive Control1 Intervention

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor

862 Previous Clinical Trials

525,406 Total Patients Enrolled

Daniel Katz, MDPrincipal InvestigatorMOUNT SINAI HOSPITAL

5 Previous Clinical Trials

589 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any ongoing opportunities for patients to participate in this research study?

"Information from clinicaltrials.gov indicates that patient enrollment for this particular study is closed. Despite not currently accepting participants, there are 227 ongoing trials actively seeking eligible individuals at this time."

Answered by AI

What are the specific goals and objectives of this research study?

"The main focus of this clinical research is to evaluate the duration of hospitalization, expected to be assessed upon discharge from the hospital within approximately 120 hours post admission. Secondary measurements will encompass ICU admittance timing - triggered when a higher level of care surpasses that offered on standard recovery floors, recorded uterotonic administration instances by anesthesiologists including oxytocin and misoprostol, as well as quantitative blood loss calculations derived from accumulated intraoperative bleeding data in designated measuring instruments like suction canisters and cell saver machines."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Impact of Intraoperative Cell Salvage

Daniel Katz 2024. "Impact of Intraoperative Cell Salvage". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06240117.