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NCT06240117 · ClinicalTrials.gov registry record · NA

Impact of Intraoperative Cell Salvage

A NA study, sponsored by Icahn School of Medicine at Mount Sinai.

Terminated
Registry status
NA
Development phase
20
Enrollment target

NCT06240117 is a NA study that was terminated before completion, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 20 participants.

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The verdict

NCT06240117, a NA study, was terminated before completion, sponsored by Icahn School of Medicine at Mount Sinai.

TERMINATED
Registry status
NA
Development phase
20 participants
Enrollment target

Study Summary

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.

Interventions

  • PROCEDURE Intraoperative cellular salvage

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2024-03-11
Est. Completion 2025-06-25
Phase NA

What the Registry Record Tells You About NCT06240117

The ClinicalTrials.gov registry entry for NCT06240117 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Intraoperative cellular salvage is the first listed.

NCT06240117 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT06240117 about?

NCT06240117 is a clinical study titled "Impact of Intraoperative Cell Salvage". 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 a...

What is the current status of trial NCT06240117?

This trial is currently terminated. It is a NA study. The enrollment target is 20 participants. The study started on 2024-03-11. Estimated completion is 2025-06-25.

What interventions are being tested in trial NCT06240117?

The interventions under investigation include: Intraoperative cellular salvage (PROCEDURE).

Who is sponsoring clinical trial NCT06240117?

This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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