Traumatic Hemothorax Clinical Trial
Official title:
Pleural Suction and Evacuation in the Moment of Thoracostomy Tube Procedure in Traumatic Hemothorax Patients: A Randomized Study
NCT number | NCT04525365 |
Other study ID # | 2017.019 |
Secondary ID | |
Status | Suspended |
Phase | N/A |
First received | |
Last updated | |
Start date | March 17, 2020 |
Est. completion date | July 31, 2024 |
Verified date | September 2023 |
Source | Hospital Pablo Tobón Uribe |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary treatment for traumatic hemothorax, is a thoracostomy tube. Some of these patients develop a clotted hemothorax by insufficient drainage. This complication needs surgical resolution and can generate an empyema. One strategy to reduce this complication is pleural suction under sedation before the thoracostomy tube. The aim of the study is define if the procedure really lower the incidence of clotted hemothorax. The investigators design and open label, randomized, interventional study, comparing the realization of the pleural suction and thoracostomy tube alone
Status | Suspended |
Enrollment | 250 |
Est. completion date | July 31, 2024 |
Est. primary completion date | March 5, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Traumatic hemothorax that needs a Thoracostomy tube procedure Exclusion Criteria: - Previous hemothorax in the same hemithorax - Hemodynamic instability - Massive hemothorax - Obtaining saliva, bile, intestinal or gastric material, chyle at the time of performing the procedure - Closed thoracostomy performed in other institution - Need of mayor surgical intervention in thorax - Contraindication for sedation |
Country | Name | City | State |
---|---|---|---|
Colombia | Pablo Tobon Uribe Hospital | Medellin | Antioquia |
Lead Sponsor | Collaborator |
---|---|
Hospital Pablo Tobón Uribe |
Colombia,
Bradley M, Okoye O, DuBose J, Inaba K, Demetriades D, Scalea T, O'Connor J, Menaker J, Morales C, Shiflett T, Brown C. Risk factors for post-traumatic pneumonia in patients with retained haemothorax: results of a prospective, observational AAST study. Injury. 2013 Sep;44(9):1159-64. doi: 10.1016/j.injury.2013.01.032. Epub 2013 Feb 19. — View Citation
DuBose J, Inaba K, Demetriades D, Scalea TM, O'Connor J, Menaker J, Morales C, Konstantinidis A, Shiflett A, Copwood B; AAST Retained Hemothorax Study Group. Management of post-traumatic retained hemothorax: a prospective, observational, multicenter AAST study. J Trauma Acute Care Surg. 2012 Jan;72(1):11-22; discussion 22-4; quiz 316. doi: 10.1097/TA.0b013e318242e368. — View Citation
Karmy-Jones R, Holevar M, Sullivan RJ, Fleisig A, Jurkovich GJ. Residual hemothorax after chest tube placement correlates with increased risk of empyema following traumatic injury. Can Respir J. 2008 Jul-Aug;15(5):255-8. doi: 10.1155/2008/918951. — View Citation
Ramanathan R, Wolfe LG, Duane TM. Initial suction evacuation of traumatic hemothoraces: a novel approach to decreasing chest tube duration and complications. Am Surg. 2012 Aug;78(8):883-7. — View Citation
Villegas MI, Hennessey RA, Morales CH, Londono E. Risk factors associated with the development of post-traumatic retained hemothorax. Eur J Trauma Emerg Surg. 2011 Dec;37(6):583-9. doi: 10.1007/s00068-010-0064-3. Epub 2010 Dec 4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clotted hemothorax | Rate of clotted hemothorax found after Thoracostomy tube procedure or pleural aspiration procedure | One month | |
Primary | Empyema | Rate of empyema found after Thoracostomy tube procedure | One month | |
Secondary | Pleural aspiration procedure complications | Describe the percentage of patients with complications associated with the pleural aspiration procedure in patients scheduled for thoracostomy tube procedure | One month |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
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Comparing 14 F Pigtail Catheter to Traditional 28-32F Chest Tube in the Management of Traumatic Hemothorax and Hemopneumothorax
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Completed |
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Multi-center:The Small (14F) Percutaneous Catheter vs. Large (28-40F) Open Chest Tube for Traumatic Hemothorax (P-CAT)
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N/A |