Evaluating Blood Clotting Times in Patients on Anticoagulants

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

This study is testing a new device to see how well it measures blood clotting times in people taking blood thinners and healthy volunteers.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Sciema UG (Academic / other)
• Locations: 5 sites (Danbury, Connecticut and 4 other locations)
• Trial ID: NCT04868214 on ClinicalTrials.gov

What this trial studies

This study evaluates the performance of the Perosphere Technologies' Point-of-Care Coagulometer in measuring clotting times of fresh whole blood samples from both healthy volunteers and patients on Direct Oral Anticoagulants (DOACs). The coagulometer initiates clotting through glass surface activation and detects fibrin assembly, providing insights into the coagulation process affected by various anticoagulants. The study will take place at three different sites, focusing on the precision of clotting time measurements and the effects of anticoagulant therapy on coagulation. Participants will include individuals aged 18 to 80 with suitable venous access.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 80 who are on prescribed anticoagulant therapy for at least one month.

Not a fit: Patients who are not on anticoagulants or those with conditions that significantly alter coagulation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the accuracy of coagulation monitoring in patients on anticoagulants, leading to better management of their treatment.

How similar studies have performed: Other studies have shown success in evaluating coagulation monitoring technologies, but this specific approach with the PoC Coagulometer is relatively novel.

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.

Where this trial is running

Danbury, Connecticut and 4 other locations

• Perosphere Technologies Inc. — Danbury, Connecticut, United States (Recruiting)
• Perosphere Technologies Inc. — Boynton Beach, Florida, United States (Recruiting)
• Perosphere Technologies Inc. — Rockville, Maryland, United States (Recruiting)
• Perosphere Technologies Inc. — White Plains, New York, United States (Recruiting)
• Pfuetzner Science and Health Institute GmbH — Mainz, Rhineland-Palatinate, Germany (Recruiting)

Study contacts

• Study coordinator: Andreas Pfuetzner, Prof.

Conditions Coagulation; coagulation; Factor Xa