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Clinical Trials/NCT06582563
NCT06582563
Not yet recruiting
Not Applicable

Study for Evaluation of Clinical Ranges of Whole Blood Clotting Times

Perosphere Technologies Inc.1 site in 1 country120 target enrollmentStarted: March 1, 2025Last updated:
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ConditionsBlood Coagulation Disorder

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Perosphere Technologies Inc.
Enrollment
120
Locations
1
Primary Endpoint
Clotting times of whole blood samples, measured on Perosphere Technologies' PoC Coagulometer devices
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

Whole blood clotting time measurements are to collect the clotting time ranges for DOAC-anticoagulated patients and assess their correlation with plasma drug levels (via anti-FXa assay).

Detailed Description

Primary objectives of the planned whole blood clotting time measurements are to collect the clotting time ranges for DOAC-anticoagulated patients and assess their correlation with plasma drug levels (via anti-FXa assay).

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •In general, study participants must:
  • •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.
  • •Eligible patients on anticoagulants must have taken their prescribed anticoagulant regularly at least for one month prior to study participation for inclusion

Exclusion Criteria

  • •Eligible patients on anticoagulants must not:
  • •Other than the condition for which a DOAC was prescribed , 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 BMI\> 40 or weight \> 120kg.
  • •Suffer from renal or hepatic insufficiency.
  • •Suffer from any pathology that would contra-indicate in general DOAC medication.
  • •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 is pregnant, breastfeeding, or planning to become pregnant during study

Outcomes

Primary Outcomes

Clotting times of whole blood samples, measured on Perosphere Technologies' PoC Coagulometer devices

Time Frame: Immediate

Whole Blood Clotting Time

Secondary Outcomes

  • Drug concentrations in collected blood samples as measured through anti-factor Xa (anti-Xa) assay(Immediate)

Investigators

Sponsor
Perosphere Technologies Inc.
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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