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The Safety of Thoracentesis, Tunneled Pleural Catheter, and Chest Tubes in Patients Taking Novel Oral Anti-Coagulants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03535883
Recruitment Status : Active, not recruiting
First Posted : May 24, 2018
Last Update Posted : October 8, 2021
Sponsor:
Information provided by (Responsible Party):
Yale University

Study Description
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Brief Summary:
To assess risks of bleeding in those individuals receiving Novel Oral Anti-Coagulant (NOAC) medications, admitted to the hospital and require thoracentesis, chest tube or tunneled pleural catheter placement.

Condition or disease Intervention/treatment
Pleural Effusion Thoracic Effusion Drug: Novel Oral Anti-Coagulants

Detailed Description:
The research component of this study simply observes and documents the outcomes of these procedures. Patients will undergo an analysis of their pre-procedural hematocrit and this will be compared to their post-procedural (next day) hematocrit.
Study Design
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Study Type : Observational
Actual Enrollment : 590 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Safety of Thoracentesis, Tunneled Pleural Catheter (Pleurx), and Chest Tubes in Patients Taking Novel Oral Anti-Coagulants (NOAC).
Actual Study Start Date : October 30, 2017
Actual Primary Completion Date : January 1, 2020
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Groups and Cohorts
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Group/Cohort Intervention/treatment
patients taking NOAC's
Patients with unilateral or bilateral pleural effusions who undergo thoracentesis, chest tube, or pleurx placement and are taking Novel Oral Anti-Coagulants (NOAC).
 Drug: Novel Oral Anti-Coagulants
Novel Oral Anti-Coagulant (NOAC) medications (i.e. Eliquis, Plavix, Xarelto etc.)
Other Name: NOAC
patients not taking NOAC's
Patients with unilateral or bilateral pleural effusions who undergo thoracentesis, chest tube, or pleurx placement who are not taking Novel Oral Anti-Coagulants (NOAC).


Outcome Measures
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Primary Outcome Measures :
  1. Risk of bleeding [ Time Frame: 2 years ]
    Reduced risk of bleeding in individuals receiving Novel Oral Anti-Coagulants as well as those that are in the control group will be assessed by having the patients undergo an analysis of their pre-procedural hematocrit which will be compared to their post procedural (next day) hematocrit


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with unilateral or bilateral pleural effusions who undergo thoracentesis, chest tube, or pleurx placement.
Criteria

Inclusion Criteria:

  1. Age > 18 y/o
  2. Unilateral or bilateral pleural effusion
  3. Ability to provide consent or consent given for the procedure and research study

Exclusion Criteria:

Adults who refuse to provide consent.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03535883


Locations
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United States, Connecticut
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Jonathan Puchalski, MD Yale University
More Information
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03535883    
Other Study ID Numbers: 2000021542
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: October 8, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases
Anticoagulants
Coagulants