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

NCT03296982 | Completed FDA Drug

• 1 other identifier: PER977-01-010
• Study Type: observational
• Target: 12
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Keywords

Whole blood clotting time

Outcome Measures

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

  1 day

Study Arms (1)

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

Blood drawn by direct venipuncture OTHER

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.

Blood Sample

edoxaban DRUG

Blood Sample

Enoxaparin DRUG

Blood Sample

Saline sham DRUG

Blood Sample

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

healthy volunteers

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.: lead
• Quintiles, Inc.: collaborator

MeSH Terms

Interventions

edoxaban; Enoxaparin

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Scott Rasmussen, MD

  Quintiles Phase 1 Services, LLC Overland Park KS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2014
• First Posted: September 29, 2017
• Study Start: December 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: May 20, 2020

Record last verified: 2017-11