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
NCT ID: NCT04868214
Last Updated: 2023-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
300 participants
OBSERVATIONAL
2021-04-20
2024-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Interventions
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coagulation measurements
peak and trough coagulation measurements of patients treated with Xarelto, Eliquis, or Lixiana and coagulation measurements of healthy proband blood spiked with eiter Xarelto, Eliquis or Lixiana.
Eligibility Criteria
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Inclusion Criteria
* 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 state of a patient (including anticoagulants, anticoagulant reversal agents, platelet inhibitors, NSAIDs and thrombolytics or "clot buster" drugs), except as specified for phase 3 of testing.
* Eligible patients on anticoagulants must: Have taken their prescribed anticoagulant regularly at least for a month prior to study participation for inclusion in phase 3 of testing
* Eligible patients on anticoagulants must: Have been on their anticoagulant therapy for at least one month.
Exclusion Criteria
* 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, surgical procedure of any type, or vaginal delivery.
* Have a history within 6 months prior to Screening of peptic ulcer or gastrointestinal bleeding (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 gingival bleeding) within 1 month prior to screening, or a long-standing history of such bleeding.
* If female, have a history of excessive or dysfunctional uterine bleeding (unless the subject had a subsequent hysterectomy).
* If female, be pregnant, breastfeeding, or planning to become pregnant during the study.
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 the condition 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 gastrointestinal bleeding (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 the subject had a subsequent hysterectomy).
* If female, be pregnant, breastfeeding, or planning to become pregnant during the study.
18 Years
80 Years
ALL
Yes
Sponsors
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Perosphere Technologies Inc.
INDUSTRY
Sciema UG
OTHER
Responsible Party
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Locations
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Perosphere Technologies Inc.
Danbury, Connecticut, United States
Perosphere Technologies Inc.
Boynton Beach, Florida, United States
Perosphere Technologies Inc.
Rockville, Maryland, United States
Perosphere Technologies Inc.
White Plains, New York, United States
Pfuetzner Science and Health Institute GmbH
Mainz, Rhineland-Palatinate, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CP-01-02-001
Identifier Type: -
Identifier Source: org_study_id
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