Evaluation of Clinical Ranges of Whole Blood Clotting Tim... | NCT06582563

Studies
Evaluation of Clinical Ranges of Whole Blood Clotting Times of Patients on Anticoagulants

NCT06582563

Sponsor

Perosphere Technologies Inc.

Status

Not yet recruiting

Last Update Posted

Oct 8, 2024Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Blood Coagulation Disorder

Interventions

Whole Blood Clotting Time

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2025Estimated

Primary Completion Date

Jul 30, 2025Estimated

Completion Date

Aug 30, 2025Estimated

First Submitted Date

Aug 21, 2024

First Submission Date that Met QC Criteria

Aug 30, 2024

First Posted Date

Sep 3, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 3, 2024

Last Update Posted Date

Oct 8, 2024Actual

Description Module

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Name	Type	Description	Arm Group Labels	Other Names
Whole Blood Clotting Time	Diagnostic Test	Comparator

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clotting times of whole blood samples, measured on Perosphere Technologies' PoC Coagulometer devices	Whole Blood Clotting Time	Immediate

Secondary Outcomes

Measure	Description	Time Frame
Drug concentrations in collected blood samples as measured through anti-factor Xa (anti-Xa) assay	Drug concentration measurements	Immediate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

In general, study participants must:
1. Be informed of the nature of the study and provide written informed consent before any study-specific procedures are performed.
2. Be 18- to 80-years-of-age, inclusive, at time of consent.
3. Have suitable venous access for at least a single venipuncture.
4. 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:
1. 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.
2. Have a BMI> 40 or weight > 120kg.
3. Suffer from renal or hepatic insufficiency.
4. Suffer from any pathology that would contra-indicate in general DOAC medication.
5. Have a history of unexplained syncope.
6. Have a history within 6 months prior to Screening of peptic ulcer or gastrointestinal bleeding (including hematemesis, melena, or rectal bleeding).
7. Consume more than 5 cigarettes per day.
8. If female, have a history of excessive or dysfunctional uterine bleeding (unless the subject had a subsequent hysterectomy).
9. If female is pregnant, breastfeeding, or planning to become pregnant during study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients treated with rivaroxaban, apixaban, or edoxaban between the ages of 18 and 80 years old. A sufficient number (12 or above) of the patients are above 70 years of age.

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Peter Verhamme, Professor	Contact	3216343491		peter.verhamme@uzleuven.be
Sasha Bakhru, PhD	Contact	475 237-4178		s.bakhru@perospheretech.com

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

ID	Term
D001780	Blood Coagulation Tests
D006403	Hematologic Tests
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures