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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02207205

Enrollment

Registered

2014-08-04

Start date

2014-04-30

Completion date

2014-06-30

Last updated

2018-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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

Detailed description

No investigational products were administered to any subjects.

Interventions

DRUGBlood drawn from indwelling catheters versus direct venipuncture

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026