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

Sponsor
Yale University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03535883
Collaborator
(none)
590
Enrollment
1
Location
56
Anticipated Duration (Months)
10.5
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • 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

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 :
Oct 30, 2017
Actual Primary Completion Date :
Jan 1, 2020
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm 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 Names:
  • 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

    Primary Outcome Measures

    1. Risk of bleeding [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

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Yale New Haven Hospital New Haven Connecticut United States 06510

    Sponsors and Collaborators

    • Yale University

    Investigators

    • Principal Investigator: Jonathan Puchalski, MD, Yale University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yale University
    ClinicalTrials.gov Identifier:
    NCT03535883
    Other Study ID Numbers:
    • 2000021542
    First Posted:
    May 24, 2018
    Last Update Posted:
    Oct 8, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pleural Effusion
    Anticoagulants
    Coagulants

    Study Results

    No Results Posted as of Oct 8, 2021