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临床试验/NCT00588133
NCT00588133已完成3 期

A Preliminary Study of a New Tranexamic Acid Dosing Schedule for Cardiac Surgery

Mayo Clinic0 个研究点目标入组 20 人开始时间: 2004年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
Mayo Clinic
入组人数
20
主要终点
Plasma tranexamic acid levels

研究概览

简要总结

Tranexamic acid is administered intravenously to prevent bleeding associated with cardiac surgery and cardiopulmonary bypass. We have developed an assay for tranexamic acid. We have developed an alternative dosing schedule for tranexamic acid. The objective of this preliminary study is to determine if this new dosing schedule can achieve the desired plasma concentration of tranexamic acid and reduce intra and inter patient variability in tranexamic acid plasma concentrations relative to the current dosing schedule.

详细描述

Tranexamic acid is administered intravenously to prevent bleeding associated with cardiac surgery and cardiopulmonary bypass. The current dosing regimen for tranexamic acid was empirically derived based upon pharmacokinetics in normal patients receiving the drug. We have developed an assay for tranexamic acid and found that the plasma concentration of tranexamic acid varies greatly between patients and also over time within each patient, especially in patients with renal insufficiency. We have developed an alternative dosing schedule for tranexamic acid that incorporates the effects of renal function on tranexamic acid concentrations. The objective of this preliminary study is to determine if this new dosing schedule can achieve the desired plasma concentration of tranexamic acid and reduce intra and inter patient variability in tranexamic acid plasma concentrations relative to the current dosing schedule. The results of this study will be used in a larger subsequent study of what level of plasma tranexamic acid concentration is needed to prevent bleeding and transfusion of blood products in patients undergoing cardiac surgery.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

  • Age 18 years old or greater having cardiac surgery.

排除标准

  • Age less than 18 years old.
  • Since tranexamic acid is not approved for pregnant patients, those extremely rare patients that are pregnant and having cardiac surgery will be excluded from the study

研究组 & 干预措施

1

Experimental

New drug dosing schedule

干预措施: tranexamic acid (Drug)

2

Active Comparator

Standard drug dosing schedule

干预措施: tranexamic acid (Drug)

结局指标

主要结局

Plasma tranexamic acid levels

时间窗: 24 hours

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other

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