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临床试验/NCT01941459
NCT01941459已完成不适用

Comparison of Blood Cardioplegia and Custodiol on Patients Operated for Significant Mitral Valve Innsufisiens. An Prospective, Randomized Two-center Study.

Ullevaal University Hospital1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2007年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
76
试验地点
1
主要终点
CK-MB ,troponin-T

研究概览

简要总结

Thru the last 20 years it has been a discussion witch solution that gives the best myocardial protection during cardiac arrest by heart operations.

  • It has been a tendency that a blood based cardioplegia gives a better protection bye long ischemic times but it has not been possible too conclude in this matter.
  • The investigators have two groups of cardioplegia, the blood based and, the crystalloid based cardioplegia.
  • It has been done a lot of studies to see what kind of cardioplegia that gives the best myocardial protection. Different temperature, different amount and content, retrograde or antegrade or both, contentiously and further on have been tested without a clear conclusion.
  • The investigators decided to make a study with a cohort of patients as homogenous as possible with a cross clamp time around 70 min.
  • Adult patients' with a severe aortic stenoses without any other significant heart disease was included in our prospective randomised study.
  • Patients with additional significant coronary artery disease (≥ 50% stenoses) were excluded from the study.
  • The investigators used the well known biomarkers CK-MB and troponin-T too evaluate the myocardial damage.

详细描述

Objective

Myocardial protection during a cardiac arrest is mostly managed with cardioplegia. To day we normally used a blood or crystalloid based solutions. It has been published a lot of papers comparing the too groups with different results. To our knowledge no prospective, randomized study has compared modified St Thomas based Blood and Crystalloid cardioplegia on the acknowledged markers (CK-MB, troponin-T) of myocardial damage during aortic valve replacement on patients without additional significant coronary artery disease.

Methods: 100 patients with aorta stenoses undergoing aortic valve replacement without significant coronary artery stenoses or other significant concomitant heart valve disease were included in the study. They were given antegrade cold blood or cold crystalloid cardioplegia delivered through the coronary Ostia every 20 min throughout the period of aortic cross-clamp. CK-MB and troponin-T were compared between the two groups.

Published 2010 in the journal of thoracic and cardiovascular surgery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
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

CK-MB ,troponin-T

时间窗: 72 hours

次要结局

未报告次要终点

研究者

发起方
Ullevaal University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bjørn Braathen

MD. Ph.D

Oslo University Hospital

研究点 (1)

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