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ACTIVE NOT RECRUITING
NCT05935267

Thoracostomy Tube Irrigation: a Multi-Center Trial

Sponsor: Methodist Health System

View on ClinicalTrials.gov

Summary

All trauma patients ages 18 years or older presenting within 24 hours of blunt or penetrating injury resulting in traumatic HTx or HPTx will be eligible for enrollment. This prospective comparative study will consist of a non-irrigation control arm and a thoracic irrigation experimental arm. Thoracic irrigation is performed at the time of the initial TT placement, and is done at the discretion of the attending Trauma surgeon. All patients enrolled will be entered in a prospectively maintained thoracic trauma database. The primary outcome is need for secondary intervention, defined as additional TT placement, VATS, tissue plasminogen activator (tPA), or thoracotomy for the management of retained HTx. Secondary interventions will be screened according to indication. Only secondary interventions directed at management of retained collection will be considered in the analysis for our primary outcome. Secondary intervention aimed at persistent air leaks or post-pull PTx will be considered separately in any analysis.

Official title: Thoracostomy Tube Irrigation: a Multi-Center Trial Investigating Its Efficacy in the Reduction of Secondary Intervention for the Management of Retained Hemothorax

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2021-12-30

Completion Date

2024-12-31

Last Updated

2024-11-20

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

thoracic irrigation

We will start this study using 20% as the approximate national intervention rate, based on current literature, with the goal of detecting a 50% reduction in the experimental arm (i.e. 10% secondary intervention rate after thoracic irrigation). Therefore, we will plan to enroll 108 patients in the irrigation cohort and 324 patients in the control cohort. An interim analysis will be conducted once 54 patients have been enrolled in the irrigation cohort. The secondary intervention rate in the irrigation cohort and the standard cohort will be determined, and any adjustments to sample size will be made at that time.

Locations (1)

Clinical Research Institute Methodist Health System

Dallas, Texas, United States