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The study was halted prematurely due to difficulties in recruiting a sufficient number of participants. Despite efforts to enroll eligible individuals, the recruitment goals were not met, making it infeasible to continue the study as planned.
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | not receiving any narcotics | |
| Morphine | Experimental | the second group will be those receiving morphine |
|
| Fentanyl | Experimental | the 3rd group will be those receiving fentanyl |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Morphine | Drug | second group will be receiving morphine |
| |
| Fentanyl |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| 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. | 2 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spectrum Health Lakeland | Saint Joseph | Michigan | 49085 | United States |
Individual Participant Data (IPD) will not be shared due to the early termination of the study and the limited number of participants enrolled. Sharing IPD from a small sample size could compromise participant confidentiality and privacy. Ensuring the protection of participants' personal data is a priority, and the small number of participants increases the risk of identifying individuals.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | not receiving any narcotics |
| FG001 | Morphine | the second group will be those receiving morphine Morphine: second group will be receiving morphine |
| FG002 | Fentanyl | the 3rd group will be those receiving fentanyl Fentanyl: third group receiving fentanyl |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | not receiving any narcotics |
| BG001 | Morphine | the second group will be those receiving morphine Morphine: second group will be receiving morphine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | Arachidonic Acid Percent | Baseline |
|
Adverse event data were collected for up to 4 hours after arrival in the ED.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | not receiving any narcotics | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rachelle Pichot; Clinical Research Specialist | Corewell Health Lakeland | 240-389-7340 | rachelle.pichot@corewellhealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 18, 2025 | Apr 8, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| Drug |
third group receiving fentanyl |
|
| BG002 | Fentanyl | the 3rd group will be those receiving fentanyl Fentanyl: third group receiving fentanyl |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
not receiving any narcotics
| OG001 | Morphine | the second group will be those receiving morphine Morphine: second group will be receiving morphine |
| OG002 | Fentanyl | the 3rd group will be those receiving fentanyl Fentanyl: third group receiving fentanyl |
|
|
| 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. | Posted | Mean | Standard Deviation | Arachidonic Acid Percent | 2 hours |
|
|
|
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Morphine | the second group will be those receiving morphine Morphine: second group will be receiving morphine | 0 | 2 | 0 | 2 | 0 | 2 |
| EG002 | Fentanyl | the 3rd group will be those receiving fentanyl Fentanyl: third group receiving fentanyl | 0 | 6 | 0 | 6 | 0 | 6 |
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| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |