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

NCT02207205 | Completed

• 1 other identifier: PER977-01-006
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.Determine the intra-subject variability in both procedures

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Catheter vs venipuncture blood samples

OTHER

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

Interventions

Blood drawn from indwelling catheters versus direct venipuncture DRUG

Evaluation of the source of blood samples on whole blood clotting time

Catheter vs venipuncture blood samples

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Healthy subjects who cannot communicate reliably with the Investigator.
• History of major bleeding or major trauma within the past 6 months
• 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).
• Significant infection or known inflammatory process within 2 weeks of screening.
• Treatment with any investigational products or therapies within 30 days (or 5 half lives, whichever is greater) prior to screening.
• Received non-steroidal anti-inflammatory drug (NSAID) or medications (including aspirin) with a direct effect on hemostasis within 7 days of testing
• Unwillingness or inability to comply with procedures required in this protocol.
• Subjects who are concurrently enrolled in any other clinical study.

Sponsors & Collaborators

• Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.: lead
• Duke Clinical Research Institute: collaborator

Study Sites (1)

Duke Clinical Research Unit

Durham, North Carolina, 27710, United States

Location

Study Officials

• Robert Noveck, MD

  Duke Clinical Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2014
• First Posted: August 4, 2014
• Study Start: April 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: June 1, 2014
• Last Updated: April 4, 2018

Record last verified: 2018-04

Locations

US (1)