HemoptysisNCT00929565
Urokinase Like Plasminogen Activator Levels in Patients Undergoing Bronchoscopy
An observational study of Hemoptysis, run by University of Oklahoma at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemoptysis
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Oct 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from the VAMC in Oklahoma city
Who may be able to join
- Any patient scheduled to undergo bronchoscopy
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Utility of Serum and Bronchoalveolar Fluid Urokinase Like Plasminogen Activator Levels in Defining Patients at Higher Risk of Hemoptysis.
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.
Read the 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.
- Conditions
- Hemoptysis
- Keywords
- hemoptysis
- Medical subject headings
- Hemoptysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lung cancer | Comparison between individuals with and without pulmonary malignancy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2010
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemoptysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gary Kinasewitz, University of Oklahoma
- Investigators
- Jijo John, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00929565
- Sponsor's protocol ID
- 14455
- Status last verified
- Apr 2012
- First submitted
- 24 Jun 2009
- Last updated
- 9 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Serum and Bronchoalveolar Fluid Urokinase Like Plasminogen Activator Levels in Defining Patients at Higher Risk of Hemoptysis.
- ClinicalTrials.gov ID
- NCT00929565
- Acronym / sponsor ID
- 14455
- Conditions
- Hemoptysis
- Keywords
- hemoptysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 29 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung cancer | – | –Comparison between individuals with and without pulmonary malignancy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from the VAMC in Oklahoma city
Key inclusion criteria (1 listed)
- Any patient scheduled to undergo bronchoscopy
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
1 secondary outcome
Volume of blood loss during the procedure
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jijo John, MD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemoptysis, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2012.