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

NCT ID: NCT03535883

Last Updated: 2023-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

590 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-30

Study Completion Date

2020-01-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pleural Effusion Thoracic Effusion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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).

Novel Oral Anti-Coagulants

Intervention Type DRUG

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

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).

No interventions assigned to this group

Interventions

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Novel Oral Anti-Coagulants

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

Intervention Type DRUG

Other Intervention Names

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NOAC

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kyle Bramley, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale New Haven Hospital

New Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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No NIH funding

Identifier Type: OTHER

Identifier Source: secondary_id

2000021542

Identifier Type: -

Identifier Source: org_study_id

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