跳至主要内容
临床试验/NCT05367336
NCT05367336终止2 期

A Comparison of PLAtelet Response to Aspirin Between Emergency Department Patients With Chest Pain Receiving Fentanyl or Morphine (PLAAFM)

Spectrum Health - Lakeland1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2022年8月31日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
终止
发起方
入组人数
21
试验地点
1
主要终点
Baseline Arachidonic Acid Maximum Aggregation (%) Result

研究概览

简要总结

The goal is to determine whether fentanyl and morphine have similar effects in reducing aspirin's effect upon platelets in emergency department patients with chest discomfort. Morphine has been shown to worsen outcomes in heart attack patients due to reduction of oral anti-platelet agent effectiveness and so many providers have switches to using fentanyl. However, it is largely unknown whether fentanyl has similar effects.

详细描述

Patients presenting to the emergency department with chest discomfort who are being administered aspirin will be offered enrollment in this study. At the time of their zero and two hour troponin we will also draw platelet aggregration studies to determine the effects of aspirin upon platelets. Narcotic medicines slow the absorption of aspirin. Morphine has therefore been shown to decrease the effectiveness of aspirin. Many providers therefore use fentanyl instead, however little is known about the effects of fentanyl upon aspirin. We will therefore compare the platelet reactivity of patients receiving morphine, fentanyl, or no narcotics

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None (Participant, Investigator)

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

  • Adult Emergency Department patients undergoing 0 and 2 hour troponin testing
  • administered aspirin within 30 minutes of the initial blood draw.
  • patient presented via private vehicle
  • provide informed consent
  • over the age of 18

排除标准

  • Patients not expected to get a 2 hour troponin;
  • patients already on aspirin, clopidogrel, or stronger anti-coagulants;
  • patients who arrived via EMS (Emergency Medical Services) given it can be difficult to find the run reports to determine whether patient received fentanyl in the pre-hospital period;
  • pregnant patients;
  • patients on chronic narcotics;
  • patients already once enrolled in this study,
  • inability to provide consent in English

研究组 & 干预措施

Morphine

Experimental

the second group will be those receiving morphine

干预措施: Morphine (Drug)

Fentanyl

Experimental

the 3rd group will be those receiving fentanyl

干预措施: Fentanyl (Drug)

结局指标

主要结局

Baseline Arachidonic Acid Maximum Aggregation (%) Result

时间窗: Baseline

Arachidonic Acid Maximum Aggregation is assessed using light transmission aggregometry (LTA). This method involves adding arachidonic acid to platelet-rich plasma (PRP) and measuring the change in light transmittance as platelets aggregate. The maximum aggregation percentage is recorded as the highest point of aggregation observed during the test. From a clinical perspective, normal aggregation is considered 70% or higher and values below 70% may indicate platelet dysfunction or the influence of antiplatelet medications such as aspirin. In this study, the control group is expected to show a significant decrease in Arachidonic Acid Maximum Aggregation (%) from the baseline to the 2-hour mark. However, this decrease is anticipated to be smaller in the groups receiving morphine and fentanyl.

2 Hour Arachidonic Acid Maximum Aggregation (%) Result

时间窗: 2 hours

Arachidonic Acid Maximum Aggregation is assessed using light transmission aggregometry (LTA). This method involves adding arachidonic acid to platelet-rich plasma (PRP) and measuring the change in light transmittance as platelets aggregate. The maximum aggregation percentage is recorded as the highest point of aggregation observed during the test. From a clinical perspective, normal aggregation is considered 70% or higher and values below 70% may indicate platelet dysfunction or the influence of antiplatelet medications such as aspirin. In this study, the control group is expected to show a significant decrease in Arachidonic Acid Maximum Aggregation (%) from the baseline to the 2-hour mark. However, this decrease is anticipated to be smaller in the groups receiving morphine and fentanyl.

次要结局

未报告次要终点

研究者

发起方
Spectrum Health - Lakeland
申办方类型
Other
责任方
Sponsor

研究点 (1)

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