PFA-100 Responsive to Effect of Energy Drinks on Platelet Function

Thrombosis Clinical Trial

Official title:

Is the PFA-100 Responsive to the Effect of Energy Drinks on Platelet Function Changes?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02997111
• Other study ID #: 27619
• Status: Completed
• Phase: N/A
• First received: December 15, 2016
• Last updated: June 21, 2017
• Start date: February 14, 2017
• Est. completion date: June 20, 2017

Study information

• Verified date: June 2017
• Source: St. Louis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the responsiveness of the Platelet Function Analyzer (PFA-100) to the effect of energy drinks on platelet function. Participants' will have blood drawn prior to and 60 minutes after ingesting 250ml of a commercially available sugar-free energy drink.

Description:

Two previous studies have demonstrated increased platelet aggregation 60 minutes after drinking a commercially available sugar-free energy drink. These studies utilized traditional platelet function studies, such as light transmission aggregometry (LTA), where platelet function is examined while adding varying concentrations of a panel of agonist to platelets. These studies are technically difficult, time intensive studies requiring specialized laboratories. They are relatively non-physiologic and do not mimic platelet response to vessel wall damage. Other tests better represent the reactions to vessel wall damage, including the PFA-100, which measures platelet aggregation and adhesion under conditions of high shear.

Overall, PFA-100 is less expensive, requires less technical skill, and is less time consuming than LTA. It has been utilized in bleeding disorders and is demonstrating promise as a marker of thrombophilia. PFA-100 has demonstrated sensitivity to drug and dietary effects. It has also shown differences in closure time between sedentary and athletic individuals PFA-100 has not been used to investigate the effect of energy drinks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: June 20, 2017
• Est. primary completion date: June 9, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• a history of consuming at least one energy drink beverage in the past 6 months without adverse effects;

• engage in moderate to strenuous physical activity more than 3 days per week.

Exclusion Criteria:

• Known thromboembolic risk including protein C or S deficiency, anti-thrombin III deficiency, Factor V Leiden;

• history of thromboembolic event;

• current or previous anti-coagulation therapy, anti-platelet therapy, calcium antagonists; - current tricyclic antidepressant therapy, current selective serotonin re-uptake inhibitor therapy; antibiotic therapy; or famotidine therapy;

• acute illness;

• pregnancy;

• hemophilia;

• significant history of cardiovascular disease and/or diabetes mellitus;

• history of adverse effect of energy drinks.

• Inability to comply with pre-test dietary and activity requirements.

Related Conditions & MeSH terms

• Platelet Function
• Thrombosis

Intervention

Device:
• PFA-100
The PFA-100 will be used to assess platelet function before and after energy drink consumption.

Locations

Country	Name	City	State
United States	Saint Louis University	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
St. Louis University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Closure time	Agonist induced platelet activation and aggregation resulting in occlusion of the aperture and cessation of blood flow termed the closure time	one hour
Secondary	blood pressure		one hour (every 15 minutes)
Secondary	pulse		one hour (every 15 minutes)