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

Launched by SCIEMA UG · Apr 27, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the PoC Coagulometer, which measures how quickly blood clots in patients who are taking anticoagulant medications (blood thinners). The goal is to see how well this device works in measuring clotting times using fresh blood samples from both healthy volunteers and patients on these medications. The trial is taking place at three different locations, and it aims to ensure that the device gives accurate results across a range of conditions and medications.

To participate in the study, you need to be between 18 and 80 years old and have suitable veins for a blood draw. Healthy volunteers should not be taking any medications that affect blood clotting, while patients on anticoagulants must have been taking their medication regularly for at least a month. Participants will need to provide written consent and may undergo a questionnaire to check for any medical history that could exclude them from the study. If you join the trial, you will help researchers understand how well this new device works, which could lead to better monitoring of blood clotting for patients on anticoagulants in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Be informed of the nature of the study and provide written informed consent before any study-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 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 any of the following findings at Study Enrollment (information will be collected via questionnaire): Positive pregnancy test (females); Drug- or alcohol abuse; Use of tobacco 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, 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.