Fentanyl, Platelet Reactivity
Conditions
Brief summary
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.
Detailed description
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
Interventions
DRUGMorphine
second group will be receiving morphine
DRUGFentanyl
third group receiving fentanyl
Sponsors
Corewell Health South
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Baseline Arachidonic Acid Maximum Aggregation (%) Result | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control not receiving any narcotics | 13 |
| Morphine the second group will be those receiving morphine
Morphine: second group will be receiving morphine | 2 |
| Fentanyl the 3rd group will be those receiving fentanyl
Fentanyl: third group receiving fentanyl | 6 |
| Total | 21 |
Baseline characteristics
| Characteristic | Control | Total | Fentanyl | Morphine |
|---|---|---|---|---|
| Age, Continuous | 54.67 years STANDARD_DEVIATION 16.62 | 54.75 years STANDARD_DEVIATION 16.08 | 56.17 years STANDARD_DEVIATION 18.06 | 51.00 years STANDARD_DEVIATION 14.14 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 17 Participants | 5 Participants | 2 Participants |
| Region of Enrollment United States | 13 participants | 21 participants | 6 participants | 2 participants |
| Sex: Female, Male Female | 7 Participants | 11 Participants | 4 Participants | 0 Participants |
| Sex: Female, Male Male | 6 Participants | 10 Participants | 2 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 2 | 0 / 6 |
| other Total, other adverse events | 0 / 13 | 0 / 2 | 0 / 6 |
| serious Total, serious adverse events | 0 / 13 | 0 / 2 | 0 / 6 |
Outcome results
Primary
2 Hour Arachidonic Acid Maximum Aggregation (%) Result
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.
Time frame: 2 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | 2 Hour Arachidonic Acid Maximum Aggregation (%) Result | 1.69 Arachidonic Acid Percent | Standard Deviation 0.56 |
| Morphine | 2 Hour Arachidonic Acid Maximum Aggregation (%) Result | 1.00 Arachidonic Acid Percent | Standard Deviation 1.2 |
| Fentanyl | 2 Hour Arachidonic Acid Maximum Aggregation (%) Result | 0.87 Arachidonic Acid Percent | Standard Deviation 1.63 |
Primary
Baseline Arachidonic Acid Maximum Aggregation (%) Result
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Baseline Arachidonic Acid Maximum Aggregation (%) Result | 37.49 Arachidonic Acid Percent | Standard Deviation 35.14 |
| Morphine | Baseline Arachidonic Acid Maximum Aggregation (%) Result | 39.00 Arachidonic Acid Percent | Standard Deviation 54.66 |
| Fentanyl | Baseline Arachidonic Acid Maximum Aggregation (%) Result | 54.00 Arachidonic Acid Percent | Standard Deviation 41.56 |