Trial Outcomes & Findings for Platelet Reactivity With Fentanyl, Morphine, or no Narcotic (NCT NCT05367336)

Last Updated: 2025-05-21

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

21 participants

Primary outcome timeframe

Baseline

Results posted on

2025-05-21

Participant Flow

Participant milestones

Participant milestones
Measure	Control not receiving any narcotics	Morphine the second group will be those receiving morphine Morphine: second group will be receiving morphine	Fentanyl the 3rd group will be those receiving fentanyl Fentanyl: third group receiving fentanyl
Overall Study STARTED	13	2	6
Overall Study COMPLETED	13	2	6
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Platelet Reactivity With Fentanyl, Morphine, or no Narcotic

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=13 Participants not receiving any narcotics	Morphine n=2 Participants the second group will be those receiving morphine Morphine: second group will be receiving morphine	Fentanyl n=6 Participants the 3rd group will be those receiving fentanyl Fentanyl: third group receiving fentanyl	Total n=21 Participants Total of all reporting groups
Age, Continuous	54.67 years STANDARD_DEVIATION 16.62 • n=5 Participants	51.00 years STANDARD_DEVIATION 14.14 • n=7 Participants	56.17 years STANDARD_DEVIATION 18.06 • n=5 Participants	54.75 years STANDARD_DEVIATION 16.08 • n=4 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	11 Participants n=4 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	10 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	17 Participants n=4 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	13 participants n=5 Participants	2 participants n=7 Participants	6 participants n=5 Participants	21 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	Control n=13 Participants not receiving any narcotics	Morphine n=2 Participants the second group will be those receiving morphine Morphine: second group will be receiving morphine	Fentanyl n=6 Participants the 3rd group will be those receiving fentanyl Fentanyl: third group receiving fentanyl
Baseline Arachidonic Acid Maximum Aggregation (%) Result	37.49 Arachidonic Acid Percent Standard Deviation 35.14	39.00 Arachidonic Acid Percent Standard Deviation 54.66	54.00 Arachidonic Acid Percent Standard Deviation 41.56

PRIMARY outcome

Timeframe: 2 hours

Outcome measures

Outcome measures
Measure	Control n=13 Participants not receiving any narcotics	Morphine n=2 Participants the second group will be those receiving morphine Morphine: second group will be receiving morphine	Fentanyl n=6 Participants the 3rd group will be those receiving fentanyl Fentanyl: third group receiving fentanyl
2 Hour Arachidonic Acid Maximum Aggregation (%) Result	1.69 Arachidonic Acid Percent Standard Deviation 0.56	1.00 Arachidonic Acid Percent Standard Deviation 1.20	0.87 Arachidonic Acid Percent Standard Deviation 1.63

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Morphine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Fentanyl

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rachelle Pichot; Clinical Research Specialist

Corewell Health Lakeland

Phone: 240-389-7340

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place