Multi-site Study for Evaluation of Clinical Ranges of Whole Blood Clotting Times of Patients on Anticoagulants and Verification of Measurement Precision of Liquid Quality Controls With the Perosphere Technologies' PoC Coagulometer

Inclusion Criteria:

• Be informed of the nature of the study and provide written informed consent before anystudy-specific procedures are performed.
• Be 18- to 80-years-of-age, inclusive, at time of consent.
• Have suitable venous access for at least a single venipuncture.
• Healthy volunteers must: Not be on medication designed to alter the coagulation stateof a patient (including anticoagulants, anticoagulant reversal agents, plateletinhibitors, NSAIDs and thrombolytics or "clot buster" drugs), except as specified forphase 3 of testing.
• Eligible patients on anticoagulants must: Have taken their prescribed anticoagulantregularly at least for a month prior to study participation for inclusion in phase 3of testing
• Eligible patients on anticoagulants must: Have been on their anticoagulant therapy forat least one month.

Exclusion Criteria:

• Have any of the following findings at Study Enrollment (information will be collectedvia questionnaire): Positive pregnancy test (females); Drug- or alcohol abuse; Use oftobacco or nicotine-containing products within 3 months prior to screening
• Have a personal or family history of clotting disorder or hematologic abnormality,such as excessive bleeding, joint hematoma, thrombovascular disease, thrombocytopenia,or any chronic condition requiring treatment with transfusions.
• Have a history of unexplained syncope.
• Have a history within 6 months prior to Screening of major bleeding, trauma, surgicalprocedure of any type, or vaginal delivery.
• Have a history within 6 months prior to Screening of peptic ulcer or gastrointestinalbleeding (including hematemesis, melena, or rectal bleeding).
• Have received any blood product or anticoagulant within 3 months prior to Screening.
• Have donated blood or blood products within 3 months prior to Screening.
• Have a history of minor bleeding episodes (e.g., epistaxis, bruising or gingivalbleeding) within 1 month prior to screening, or a long-standing history of suchbleeding.
• If female, have a history of excessive or dysfunctional uterine bleeding (unless thesubject had a subsequent hysterectomy).
• If female, be pregnant, breastfeeding, or planning to become pregnant during thestudy. Eligible patients on anticoagulants must not:
• Have a personal or family history of clotting disorder or hematologic abnormality,such as excessive bleeding, joint hematoma, thrombovascular disease, thrombocytopenia,or any chronic condition requiring treatment with transfusions, other than thecondition for which a DOAC was prescribed.
• Have a history of unexplained syncope.
• Have a history within 6 months prior to Screening of peptic ulcer or gastrointestinalbleeding (including hematemesis, melena, or rectal bleeding).
• Consume more than 5 cigarettes per day.
• If female, have a history of excessive or dysfunctional uterine bleeding (unless thesubject had a subsequent hysterectomy).
• If female, be pregnant, breastfeeding, or planning to become pregnant during thestudy.