Drainage Amount for Removal of Thoracostomy Tube
DARTT
Non-inferiority Randomized Trial Evaluating Removal of Thoracostomy Tubes Independent of the Drainage Amount Versus Removal When the Drainage Amount Is Low
1 other identifier
interventional
280
1 country
1
Brief Summary
The purpose of this study is to determine whether chest tubes can be safely removed without considering how much fluid is draining through the tube.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 14, 2007
CompletedFirst Posted
Study publicly available on registry
December 18, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedJune 21, 2017
June 1, 2017
4.8 years
December 14, 2007
June 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Invasive drainage procedure
Within 60 days
Secondary Outcomes (3)
Time to thoracostomy tube removal
Within 60 days
Pulmonary symptoms
60 days
Mortality
60 days
Study Arms (2)
1
EXPERIMENTALNo drainage threshold
2
ACTIVE COMPARATORDrainage \<2 mL/kg
Interventions
Removal of the thoracostomy tube independently of the amount of fluid that drained from the tube in the prior 24 hours
Removal of the thoracostomy tube only if the drainage from the tube in the prior 24 hours is less than 2 mL/kg of the patient's ideal body weight
Eligibility Criteria
You may qualify if:
- Thoracostomy tube in place for \<72 hours
- Age at least 14 years
- Hospitalized for traumatic injury or elective operation
You may not qualify if:
- Thoracostomy tube already removed from the pleural cavity of interest
- Mediastinal tubes
- Death expected within 48 hours
- Prisoner status
- Severe congestive heart failure
- End-stage liver disease
- End-stage renal disease
- History of or suspected empyema involving the pleural cavity of interest
- History of or anticipated need for pleurodesis of the pleural cavity of interest
- Malignant pleural effusion
- Pregnancy
- Previous participation in this study
- Thoracostomy tube drainage already \<2 mL/kg
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, Davis, Medical Center
Sacramento, California, 95817, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Garth H Utter, MD MSc
University of California, Davis
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2007
First Posted
December 18, 2007
Study Start
December 1, 2007
Primary Completion
September 1, 2012
Study Completion
December 1, 2012
Last Updated
June 21, 2017
Record last verified: 2017-06