Clinical trial NCT04868214: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coagulation
Keywords: coagulation
Factor Xa
Lead sponsor: Sciema UG
Sponsor class: OTHER
Collaborators: name: Perosphere Technologies Inc.
First posted: 2021-04-30
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients on rivaroxaban, apixaban, or edoxaban and healthy volunteers between the ages of 18 and 80 years old

Brief summary: The Perosphere Technologies' PoC Coagulometer measures clotting times of fresh whole blood samples. Clotting is initiated by glass surface activation and terminates on optical detection of fibrin assembly, the final step in the coagulation cascade. Since activation occurs at the top of the intrinsic pathway and detection occurs at the bottom of the final common pathway, the Perosphere Technologies' PoC Coagulometer has shown sensitivity to a broad range of drugs and reagents that affect blood clotting processes, including the Direct Oral Anticoagulants, DOACs (e.g. rivaroxaban, apixaban, and edoxaban), as well as the heparins (e.g. enoxaparin, a low molecular weight heparin, and unfractionated heparin). The purpose of the present study is to characterize the performance of the PoC Coagulometer measuring Clotting Time Controls, as well as fresh whole blood from both healthy volunteers and DOAC patients at three field testing sites.


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.

Primary outcomes:
measure: Clotting times of whole blood samples, measured on Perosphere Technologies' PoC Coagulometer devices
timeFrame: During the first/single study visit
Secondary outcomes:
measure: Drug concentrations in collected blood samples as measured through anti-factor Xa (anti-Xa) assay
timeFrame: During the first/single study visit
Other outcomes:
Locations:
city: Danbury
country: United States
facility: Perosphere Technologies Inc.
state: Connecticut
city: Boynton Beach
country: United States
facility: Perosphere Technologies Inc.
state: Florida
city: Rockville
country: United States
facility: Perosphere Technologies Inc.
state: Maryland
city: White Plains
country: United States
facility: Perosphere Technologies Inc.
state: New York
city: Mainz
country: Germany
facility: Pfuetzner Science and Health Institute GmbH
state: Rhineland-Palatinate
Study officials:
References: