Variability in the Measurement of WBCT Between Blood Drawn From Indwelling Catheters and Direct Venipuncture

A Study to Determine Variability in the Measurement of Whole Blood Clotting Time (WBCT) Between Blood Drawn From Indwelling Catheters and Direct Venipuncture

1. Determine if there is any difference between the whole blood clotting time results obtained from blood drawn from indwelling catheters and direct venipuncture
2. Determine the intra-subject variability in both procedures

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Blood drawn from indwelling catheters versus direct venipuncture

Detailed Description

No investigational products were administered to any subjects.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Signed and dated, written informed consent (Institutional Review Board [IRB]-approved informed consent form [ICF]).
2. Healthy (as determined by medical history) male and female subjects aged 18 to 65 years (inclusive) with suitable veins for venipuncture.

Exclusion Criteria:

1. Healthy subjects who do not conform to the above inclusion criteria.
2. Healthy subjects who cannot communicate reliably with the Investigator.
3. History of major bleeding or major trauma within the past 6 months
4. Healthy volunteer with a propensity to bleed (i.e. due to recent trauma, recent surgery, peptic ulcer, active or recent gastrointestinal bleeding or bleeding from hemorrhoids).
5. Significant infection or known inflammatory process within 2 weeks of screening.
6. Treatment with any investigational products or therapies within 30 days (or 5 half lives, whichever is greater) prior to screening.
7. Received non-steroidal anti-inflammatory drug (NSAID) or medications (including aspirin) with a direct effect on hemostasis within 7 days of testing
8. Unwillingness or inability to comply with procedures required in this protocol.
9. Subjects who are concurrently enrolled in any other clinical study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Catheter vs venipuncture blood samples; Evaluation of whether there is any difference in results of whole blood clotting time in blood samples drawn from an indwelling catheter versus direct venipuncture	Drug: Blood drawn from indwelling catheters versus direct venipuncture; Evaluation of the source of blood samples on whole blood clotting time

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Whole blood clotting time results from blood drawn from indwelling catheters and direct venipuncture	Comparison of results in whole blood clotting time from blood sampled by direct venipuncture and from indwelling catheters as assessed by multiple technicians	single day sampling

Collaborators and Investigators

• Sponsor: Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.
• Collaborators: Duke Clinical Research Institute
• Investigators: Principal Investigator: Robert Noveck, MD, Duke Clinical Research Unit

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: July 28, 2014
• First Submitted That Met QC Criteria: July 30, 2014
• First Posted (Estimate): August 4, 2014

Study Record Updates

• Last Update Posted (Actual): April 4, 2018
• Last Update Submitted That Met QC Criteria: April 3, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: PER977-01-006