NCT00795743

Brief Summary

Hypothesis to be tested: placement of a central venous catheter will induce a systemic hypercoagulable state. To determine this, the investigators will measure thromboelastography (TEG), PT(prothrombin time), PTT (partial thromboplastin time), Prothrombin Fragment 1.2, Factor VIII, and VonWillebrand's Factor. In addition, duplex ultrasound will be performed to correlate the laboratory coagulation values with functional changes (i.e. deep venous thrombosis).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 21, 2008

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

May 6, 2014

Status Verified

May 1, 2014

Enrollment Period

4.3 years

First QC Date

November 19, 2008

Last Update Submit

May 5, 2014

Conditions

Deep Vein Thrombosis

Keywords

Central Venous Catheterizationcoagulopathythromboelastography

Outcome Measures

Primary Outcomes (1)

  • Coagulopathy

    3 hours surrounding placement of catheter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

PAtients requiring placement of a central venous catheter.

You may qualify if:

  • All patients undergoing placement of a central venous catheter.

You may not qualify if:

  • Age under 18 or known coagulation disorder (inherited or pharmacologic).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ryder Trauma Center

Miami, Florida, 33136, United States

Location

Related Publications (1)

  • King DR, Cohn SM, Feinstein AJ, Proctor KG. Systemic coagulation changes caused by pulmonary artery catheters: laboratory findings and clinical correlation. J Trauma. 2005 Oct;59(4):853-7; discussion 857-9. doi: 10.1097/01.ta.0000187656.26849.39.

    PMID: 16374273BACKGROUND

MeSH Terms

Conditions

Venous ThrombosisHemostatic Disorders

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Kenneth G Proctor, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 19, 2008

First Posted

November 21, 2008

Study Start

February 1, 2008

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

May 6, 2014

Record last verified: 2014-05

Locations

US(1)