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临床试验/NCT06240117
NCT06240117终止不适用

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

Icahn School of Medicine at Mount Sinai2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年3月11日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
20
试验地点
2
主要终点
The difference in postoperative hemoglobin at 48hrs compared to preoperative baseline

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

The difference in postoperative hemoglobin at 48hrs compared to preoperative baseline

时间窗: Baseline and 48 hours postoperatively

The difference in postoperative hemoglobin at 48hrs

Length of hospital stay

时间窗: at hospital discharge, likely within 120 hours from admission

Length of hospital stay

Total blood volume transfused

时间窗: at hospital discharge, likely within 120 hours from admission

Total blood volume transfused

Number of participants requiring allogeneic blood product transfusions

时间窗: at hospital discharge, likely within 120 hours from admission

Need of allogeneic blood product transfusions

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

时间窗: at hospital discharge, likely within 120 hours from admission

Quantity of allogeneic blood product transfusion

次要结局

  • Anemia-Fatigue Scale (FACIT-F) Score(at 48 hours postpartum)
  • Number of participants being administered uterotonics(within 30 minutes of the end of the surgical procedure (approximately 2 hours))
  • APGAR Scores(at 5 minutes post-delivery)
  • The Edinburgh Postnatal Depression Scale (EPDS) Score(Up to 6 weeks postpartum)
  • Number of participants admitted to intensive care unit (ICU)(Until hospital discharge, likely within 120 hours from admission)
  • The timing for intensive care unit (ICU)(Until hospital discharge, likely within 120 hours from admission)
  • Quantitative blood loss(within 30 minutes of the end of the surgical procedure (approximately 2 hours))
  • The Obstetric Quality of Recovery-10 (OBSQOR-10) Score(at 48 hours postpartum)
  • Amount of postoperative blood product transfusion(Until hospital discharge, likely within 120 hours from admission)
  • Time to first dosage of pressors(Until hospital discharge, likely within 120 hours from admission)
  • Use of postoperative uterine compression devices(Until hospital discharge, likely within 120 hours from admission)
  • Timing of postoperative uterine compression devices(Until hospital discharge, likely within 120 hours from admission)
  • Number of participants receiving postoperative intravenous iron(Until hospital discharge, likely within 120 hours from admission)
  • Reason for intensive care unit (ICU)(Until hospital discharge, likely within 120 hours from admission)
  • Use of postoperative blood product transfusion(Until hospital discharge, likely within 120 hours from admission)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel Katz

Professor

Icahn School of Medicine at Mount Sinai

研究点 (2)

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