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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

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ClinicalTrials.gov Identifier: NCT04868214
Recruitment Status : Recruiting
First Posted : April 30, 2021
Last Update Posted : April 30, 2021
Sponsor:
Collaborator:
Perosphere Technologies
Information provided by (Responsible Party):
Sciema UG

Study Description
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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.

Condition or disease Intervention/treatment
Coagulation Device: coagulation measurements

Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
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
Actual Study Start Date : April 20, 2021
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Device: 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.

Outcome Measures
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Primary Outcome Measures :
  1. Clotting times of whole blood samples, measured on Perosphere Technologies' PoC Coagulometer devices [ Time Frame: During the first/single study visit ]
    Clotting times measured on Perosphere Technologies´ PoC of patients on Xarelto, Eliquis or Lixiana


Secondary Outcome Measures :
  1. Drug concentrations in collected blood samples as measured through anti-factor Xa (anti-Xa) assay [ Time Frame: During the first/single study visit ]
    Drug concentrations in collected blood samples as measured through anti-factor Xa (anti-Xa) assay


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04868214


Contacts
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Contact: Andreas Pfuetzner, Prof. +4961315884640 info@pfuetzner-mainz.com
Contact: Silvia Scherer +4961315884640 info@pfuetzner-mainz.com

Locations
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Germany
Pfuetzner Science and Health Institute GmbH Recruiting
Mainz, Rhineland-Palatinate, Germany, 55128
Contact: Andreas Pfuetzner, Prof.    +4961315884640    info@pfuetzner-mainz.com   
Contact: Silvia Scherer    +4961315884640    info@pfuetzner-mainz.com   
Principal Investigator: Andreas Pfuetzner, Prof.         
Sponsors and Collaborators
Sciema UG
Perosphere Technologies
More Information
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Responsible Party: Sciema UG
ClinicalTrials.gov Identifier: NCT04868214    
Other Study ID Numbers: CP-01-02-001
First Posted: April 30, 2021    Key Record Dates
Last Update Posted: April 30, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD will be shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sciema UG:
coagulation
Factor Xa
Additional relevant MeSH terms:
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Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases