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

Completed

• Conditions: Thoracic Effusion; Pleural Effusion
• Interventions: Drug: Novel Oral Anti-Coagulants

• Registration Number: NCT03535883
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-10-30
• Study First Submitted: 2018-05-08
• Study First Submitted QC: 2018-05-22
• Study First Posted: 2018-05-24
• Primary Completion: 2020-01-01
• Study Completion: 2020-01-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-11
• Last Update Posted: 2023-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 590

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

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Exclusion Criteria

Adults who refuse to provide consent.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients taking NOAC's	Novel Oral Anti-Coagulants	Patients with unilateral or bilateral pleural effusions who undergo thoracentesis, chest tube, or pleurx placement and are taking Novel Oral Anti-Coagulants (NOAC).

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States