Variability of Whole Blood Clotting Time Measurements in Ex Vivo Human Blood Samples Spiked With Anticoagulants

A Study to Determine the Inter/Intra Observer and Intra-Subject Variability of Whole Blood Clotting Time Measurements in Ex Vivo Human Blood Samples Spiked With Anticoagulants

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03296982

Enrollment

Registered

2017-09-29

Start date

2014-12-31

Completion date

2015-02-28

Last updated

2020-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Whole blood clotting time

Brief summary

The study will assess the distribution and variability of whole blood clotting time (WBCT) measurement in human blood collected from healthy volunteers that is untreated and spiked with predetermined concentrations of edoxaban or enoxaparin.

Detailed description

Twelve healthy volunteers aged 18 to 65 years (6 subjects per spiking anticoagulant) will be enrolled. A total of 8 blood samples (12 mL/sample) will be collected by direct venipuncture. The samples from will be spiked with predetermined concentrations of edoxaban or enoxaparin (baseline, saline control and 6 specified concentrations of anticoagulant). Each blood sample will be tested for whole blood clotting time (WBCT), Point of Care activated partial thromboplastin time (aPTT) and prothrombin time (PT).

Interventions

OTHERBlood drawn by direct venipuncture

Subjects will have blood sampled (12 mL/sample) a total of 8 times by direct venipuncture. Samples will be spiked with predetermined concentrations of anticoagulants, or saline sham.

DRUGedoxaban

DRUGEnoxaparin

DRUGSaline sham

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

1. Signed and dated informed consent form 2. Healthy male and female subjects aged 18 to 65 years (inclusive) with suitable veins for venipuncture -

Exclusion criteria

1. Subjects who cannot communicate reliably with the Investigator 2. History of major bleeding or major trauma within the 6 months prior to signing informed consent 3. Propensity to bleeding (i.e. due to recent trauma, surgery, peptic ulcer, gastrointestinal bleeding or hemorrhoids) 4. Significant infection or known inflammatory process in the 2 weeks prior to screening 5. Active smoker or current use of any tobacco products or use within 3 months prior to signing informed consent 6. Treatment with any investigation product or therapy within 30 days prior to screening 7. Received non-steroidal antiinflammatory drugs or medications (including anticoagulants or aspirin) with a direct effect on hemostasis within 7 days of blood sampling 8. Unwilling to comply with the procedures in the protocol 9. Currently enrolled in any other study -

Design outcomes

Primary

Measure	Time frame	Description
Distribution and variability of WBCT measurements	1 day	Assessment of the analytical measurement range, reproducibility and precision of WBCT measurement in human blood spiked with predetermined concentrations of enoxparin and edoxaban

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026