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临床试验/NCT02751645
NCT02751645Unknown不适用

The Efficacy and Safety of Acute Normovolemic Hemodilution in Pediatric Cardiac Surgery Patients

Oregon Health and Science University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2016年6月30日最近更新:
适应症

试验速览

阶段
不适用
入组人数
24
试验地点
2
主要终点
Effectiveness of ANH to decrease volume of blood products during surgery and the immediate post-operative period.

研究概览

简要总结

The investigators primary objective is to determine if acute normovolemic hemodilution (ANH) for pediatric cardiac surgical patients decreases the volume of blood products transfused during surgery and the immediate post-operative period as compared to usual care. This study will enroll 24 pediatric heart surgery patients, aged 6 months to 3 years old undergoing either ANH prior to initiating cardiopulmonary bypass or the standard of care procedures for the use of cardiopulmonary bypass.

详细描述

Blood transfusion has been associated with worse outcomes in pediatric cardiac surgical patients. The major complications associated with it include increased blood loss during and after surgery, kidney disease requiring dialysis, abnormal coagulation profile, increased vasopressor use, and increased time spent on the ventilator and in the intensive care unit. One strategy to minimize blood product administration is acute normovolemic hemodilution (ANH). The investigators primary aim is to determine if ANH for pediatric cardiac surgical patients decreases the volume of blood products transfused during surgery and the immediate post-operative period, compared to usual care. The investigators designed a randomized, controlled, open label study that equally assigns 24 pediatric cardiac surgery patients aged 6 months to 3 years into two groups to receive either ANH prior to initiating cardiopulmonary bypass or usual standard of care. Participants in the ANH arm of the study will have 10 ml/kg of blood removed following anesthetic induction. In order to maintain normal circulating volume, the collected blood will be replaced with an equal volume of 5% albumin. All participants will be treated with a standardized protocol aimed at blood conservation including the use of retrograde arterial and antegrade venous perfusion, small circuit size, intraoperative red blood cell salvage, and low hemoglobin targets to trigger transfusion.

研究设计

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

入排标准

年龄范围
6 Months 至 3 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Informed signed consent must be obtained by a legally authorized representative.
  • Must be undergoing an elective surgical repair or palliation of a cardiac defect with the use of the cardiopulmonary bypass machine.
  • Must be clinically stable at the time of evaluation for eligibility and on the day of randomization.

排除标准

  • Patients who carry a diagnosis of a bleeding disorder.
  • Patients who have an abnormal coagulation profile as evidenced by a preoperative coagulation screen.
  • Patients who have received a blood transfusion in the preceding 120 days.
  • Patients who have a diagnosis of a chromosomal abnormality.
  • Patients whose participation in the study is deemed unsafe by their primary care team.

结局指标

主要结局

Effectiveness of ANH to decrease volume of blood products during surgery and the immediate post-operative period.

时间窗: 2 Days

This will be measured by comparing the volume (mL/Kg body weight) of any blood products administered peri-operatively between the two groups.

次要结局

  • Hematocrit and platelet count on post-operative day 1(1 days)
  • Duration of mechanical ventilation and ICU stay(8 days)
  • Kidney function(2 days)
  • Normalization of thromboelastogrpahy (TEG) MA value (maximum amplitude)(2 days)
  • Normalization of thromboelastography (TEG) Alpha Angle value(2 days)
  • Time to end of vasoactive support in the first 24 hours post-operation.(1 days)
  • Normalization of thromboelastography (TEG) R value (reaction time)(2 days)
  • Final hematocrit, platelet count, PT/PTT on ICU admission(1 day)

研究者

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

Weronika Crescini, MD

Assistant Professor

Oregon Health and Science University

研究点 (2)

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