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

Recruiting

• Conditions: Coagulation

• Registration Number: NCT04868214
• Lead Sponsor: Sciema UG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-30
• Study Start: 2021-04-20
• Study First Submitted QC: 2021-04-27
• Study First Posted: 2021-04-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-25
• Last Update Posted: 2023-09-28
• Primary Completion: 2024-08-31
• Study Completion: 2024-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clotting times of whole blood samples, measured on Perosphere Technologies' PoC Coagulometer devices	During the first/single study visit	Clotting times measured on Perosphere Technologies´ PoC of patients on Xarelto, Eliquis or Lixiana

Secondary Outcome Measures

Name	Time	Method
Drug concentrations in collected blood samples as measured through anti-factor Xa (anti-Xa) assay	During the first/single study visit	Drug concentrations in collected blood samples as measured through anti-factor Xa (anti-Xa) assay

Trial Locations

Locations (2)

Pfuetzner Science and Health Institute GmbH; 🇩🇪 Mainz, Rhineland-Palatinate, Germany

Perosphere Technologies Inc.; 🇺🇸 White Plains, New York, United States