Urokinase Like Plasminogen Activator Levels in Patients U... | NCT00929565

Studies
Urokinase Like Plasminogen Activator Levels in Patients Undergoing Bronchoscopy

NCT00929565

Sponsor

University of Oklahoma

Status

Completed

Last Update Posted

Apr 9, 2012Estimated

Enrollment

10Actual

Phase

Not provided

Conditions

Hemoptysis

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Jun 2010Actual

Completion Date

Oct 2011Actual

First Submitted Date

Jun 24, 2009

First Submission Date that Met QC Criteria

Jun 25, 2009

First Posted Date

Jun 29, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 5, 2012

Last Update Posted Date

Apr 9, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Some of the risk factors for bleeding following bronchoscopy is having a malignancy or an immunocompromised state. The etiology of this remains uncertain. The investigators suspect that individuals with malignancy have abnormalities involving certain factors that influence the coagulation pathway.

The investigators plan to measure these factors prior to and after bronchoscopy.

Detailed Description

This is a prospective observational study looking at some coagulation factors in individuals with lung cancer. We are looking at BAL and plasma. We would like to see if there is a difference in the levels and if this is the reason behind the higher incidence of hemoptysis in patients with lung cancer.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lung cancer		Comparison between individuals with and without pulmonary malignancy

Interventions

Not provided

Measure	Description	Time Frame
Volume of blood loss during the procedure		1 day

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any patient scheduled to undergo bronchoscopy

Exclusion Criteria:

Patients with evidence of coagulopathy either iatrogenic or the result of disease process - coagulopathy defined as elevated prothrombin time, activated partial thromboplastin time or platelet count less than 100,000
Patients not scheduled to undergo bronchoalveolar lavage (BAL)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients from the VAMC in Oklahoma city

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jijo John, MD	University of Oklahoma	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
VA Medical Center		Oklahoma City	Oklahoma	73104	United States

Condition Browse Module

MeSH Terms

ID	Term
D006469	Hemoptysis

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D006470	Hemorrhage
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided