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CompletedNCT03296982Updated May 20, 2020

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

An observational study in Healthy, sponsored by Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.. Completed. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-20.

Sponsored by Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
12
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Healthy

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Keywords

  • Whole blood clotting time
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

healthy volunteers

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

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 -
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
12 participants (actual)
Patient registry
No

Groups and cohorts

  • Blood Sample

    Blood will be sampled by direct venipuncture on 8 occasions.

    Other: Blood drawn by direct venipuncture · Drug: edoxaban · Drug: Enoxaparin · Drug: Saline sham

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
05

What researchers measure

Primary outcomes

  1. Distribution and variability of WBCT measurements

    Assessment of the analytical measurement range, reproducibility and precision of WBCT measurement in human blood spiked with predetermined concentrations of enoxparin and edoxaban

    Time frame: 1 day

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT03296982
Lead sponsor
Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.
Collaborators
Quintiles, Inc.
Responsible party
Sponsor
First posted
Sep 29, 2017
Start date
Dec 2014
Primary completion
Feb 2015
Completion
Feb 2015
Last update
May 20, 2020

Study contacts

Scott Rasmussen, MD
principal investigator · Quintiles Phase 1 Services, LLC Overland Park KS

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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