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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03296982
• Other study ID #: PER977-01-010
• Status: Completed
• Start date: December 2014
• Est. completion date: February 2015

Study information

• Verified date: November 2017
• Source: AMAG Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Healthy
• Thrombosis

Intervention

Other:
• Blood 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.

Drug:
• edoxaban

• Enoxaparin

• Saline sham

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.	Quintiles, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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