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

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ClinicalTrials.gov Identifier: NCT03535883
Recruitment Status : Recruiting
First Posted : May 24, 2018
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Yale University

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.

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Study Type : Observational
Estimated Enrollment : 318 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
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

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).



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



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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.


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


Contacts
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Contact: Zubaida Dabre, RN BA 203-737-5403 zubaida.dabre@yale.edu

Locations
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United States, Connecticut
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06510
Contact: Jonathan T Puchalski, MD,MEd    203-737-5688    jonathan.puchalski@yale.edu   
Contact: Zubaida L Dabre, BA, RN    203-737-5403    zubaida.dabre@yale.edu   
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Jonathan Puchalski, MD Yale University

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03535883     History of Changes
Other Study ID Numbers: 2000021542
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019

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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
Coagulants
Anticoagulants