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NCT03535883 Clinical Trial

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

Pleural Effusion Clinical Trial

Official title:
The Safety of Thoracentesis, Tunneled Pleural Catheter (Pleurx), and Chest Tubes in Patients Taking Novel Oral Anti-Coagulants (NOAC).

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03535883
Other study ID # 2000021542
Secondary ID No NIH funding
Status Completed
Phase
First received
Last updated
Start date October 30, 2017
Est. completion date January 1, 2020

Study information
Verified date October 2023
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 590
Est. completion date January 1, 2020
Est. primary completion date January 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Yale New Haven Hospital New Haven Connecticut

Sponsors (1)
Lead Sponsor Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 2 years
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