Clinical trial NCT05628974: Normal Donor Blood Draws for Platelet Studies and Biomarker Evaluation (ND-PLT)
Official title: Normal Donor Blood Draws for Platelet Studies and Biomarker Evaluation (ND-PLT)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-11-29
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Voluntary donors will be screened by questioning for use of anti-coagulant medications such as aspirin or other non-steroidal anti-inflammatory agents, in the past 10 days, or for hematopoietic diseases. Only healthy volunteers included as platelet donors.

Brief summary: This is a single-center study at the Cleveland Clinic Main Campus designed to study biomarkers in healthy individuals to identify novel mechanisms of platelet activation and how platelets drive vascular inflammation and thrombosis in diseases.

Detailed description: Our past studies have discovered novel platelet activation pathways that may be targets of therapeutic development. We have also defined an important role for a shift in platelet phenotype in vascular disease. Our studies use both in vivo animal models and validation using human platelets from isolated blood. Platelets from healthy individuals may be compared to patients with vascular diseases in the IRB approved protocol "Vascular Lab Resource" (IRB #19-1451) study which is actively recruiting patients at the Cleveland Clinic Main Campus and studies patients with vascular diseases.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18 to 65 years old
* Healthy Male \& Female voluntary participants

Exclusion Criteria:

* Individuals who have taken anticoagulant or antiplatelet medications in past 10 days
* Individuals with hematopoetic diseases

Primary outcomes:
measure: To collect blood samples
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Scott Cameron, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cameron SJ, Ture SK, Mickelsen D, Chakrabarti E, Modjeski KL, McNitt S, Seaberry M, Field DJ, Le NT, Abe J, Morrell CN. Platelet Extracellular Regulated Protein Kinase 5 Is a Redox Switch and Triggers Maladaptive Platelet Responses and Myocardial Infarct Expansion. Circulation. 2015 Jul 7;132(1):47-58. doi: 10.1161/CIRCULATIONAHA.115.015656. Epub 2015 May 1.
citation: Schmidt RA, Morrell CN, Ling FS, Simlote P, Fernandez G, Rich DQ, Adler D, Gervase J, Cameron SJ. The platelet phenotype in patients with ST-segment elevation myocardial infarction is different from non-ST-segment elevation myocardial infarction. Transl Res. 2018 May;195:1-12. doi: 10.1016/j.trsl.2017.11.006. Epub 2017 Dec 2.
citation: Hilt ZT, Pariser DN, Ture SK, Mohan A, Quijada P, Asante AA, Cameron SJ, Sterling JA, Merkel AR, Johanson AL, Jenkins JL, Small EM, McGrath KE, Palis J, Elliott MR, Morrell CN. Platelet-derived beta2M regulates monocyte inflammatory responses. JCI Insight. 2019 Mar 7;4(5):e122943. doi: 10.1172/jci.insight.122943. eCollection 2019 Mar 7.
citation: Faraday N, Goldschmidt-Clermont PJ, Bray PF. Gender differences in platelet GPIIb-IIIa activation. Thromb Haemost. 1997 Apr;77(4):748-54.