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CompletedNCT03535883Updated Oct 13, 2023

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

An observational study in Pleural Effusion and Thoracic Effusion, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-13.

Sponsored by Yale University · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
590
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pleural Effusion
  • Thoracic Effusion

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03

In context

Pleural Effusion

335 studies on the registry are indexed under Pleural Effusion; 63 are open to participants now.

This study's enrollment of 590 is above the median of 104 across 105 observational studies indexed under Pleural Effusion.

Browse Pleural Effusion studies →

Lead sponsor

Yale University is the lead sponsor of 1,763 studies on the registry; 292 are open to participants now.

Of its 217 completed or terminated interventional studies of FDA-regulated products, 128 (59%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

Adults who refuse to provide consent.

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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
590 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • 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).

Interventions

  • DrugNovel Oral Anti-Coagulants

    Novel Oral Anti-Coagulant (NOAC) medications (i.e. Eliquis, Plavix, Xarelto etc.)

    Also known as: NOAC

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What researchers measure

Primary outcomes

  1. Risk of bleeding

    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

    Time frame: 2 years

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Study locations

1 site
  • Yale New Haven Hospital
    New Haven, Connecticut 06510, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03535883
Lead sponsor
Yale University
Responsible party
Sponsor
First posted
May 24, 2018
Start date
Oct 30, 2017
Primary completion
Jan 1, 2020
Completion
Jan 1, 2020
Last update
Oct 13, 2023

Study contacts

Kyle Bramley, MD
principal investigator · Yale University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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