NCT00929565

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2009

Typical duration 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

June 1, 2009

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 29, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

April 9, 2012

Status Verified

April 1, 2012

Enrollment Period

1 year

First QC Date

June 24, 2009

Last Update Submit

April 5, 2012

Conditions

Keywords

hemoptysis

Outcome Measures

Secondary Outcomes (1)

  • Volume of blood loss during the procedure

    1 day

Study Arms (1)

Lung cancer

Comparison between individuals with and without pulmonary malignancy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients from the VAMC in Oklahoma city

You may qualify if:

  • Any patient scheduled to undergo bronchoscopy

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Hemoptysis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, RespiratorySigns and Symptoms

Study Officials

  • Jijo John, MD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 24, 2009

First Posted

June 29, 2009

Study Start

June 1, 2009

Primary Completion

June 1, 2010

Study Completion

October 1, 2011

Last Updated

April 9, 2012

Record last verified: 2012-04

Locations