Pleural Suction Additional to Thoracostomy Tube for Traumatic Hemothorax

NCT04525365 | Suspended

• 1 other identifier: 2017.019
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Traumatic Hemothorax

Outcome Measures

Primary Outcomes (2)

• Clotted hemothorax

  Rate of clotted hemothorax found after Thoracostomy tube procedure or pleural aspiration procedure

  One month

• Empyema

  Rate of empyema found after Thoracostomy tube procedure

  One month

Secondary Outcomes (1)

• Pleural aspiration procedure complications

  One month

Study Arms (2)

Pleural aspiration

EXPERIMENTAL

Pleural aspiration under sedation

Procedure: Pleural aspiration

Closed Thoracostomy

ACTIVE COMPARATOR

Actual management

Procedure: Pleural aspiration

Interventions

Pleural aspiration PROCEDURE

Pleural aspiration

Also known as: Closed Thoracostomy

Closed Thoracostomy; Pleural aspiration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Traumatic hemothorax that needs a Thoracostomy tube procedure

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Pablo Tobón Uribe: lead

Study Sites (1)

Pablo Tobon Uribe Hospital

Medellín, Antioquia, 050034, Colombia

Location

Related Publications (5)

• 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.

  PMID: 22856496 BACKGROUND

• 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.

  PMID: 18716687 BACKGROUND

• 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.

  PMID: 23433600 BACKGROUND

• 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.

  PMID: 22310111 BACKGROUND

• 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.

  PMID: 26815469 BACKGROUND

MeSH Terms

Interventions

Thoracentesis

Intervention Hierarchy (Ancestors)

Paracentesis; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Willfredy Castano, MD

  Pablo Tobon Uribe Hospital, Thoracic Surgeon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pleural suction under sedation vs Tube Thoracostomy without pleural suction

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: August 25, 2020
• Study Start: March 17, 2020
• Primary Completion: March 5, 2024
• Study Completion: July 31, 2024
• Last Updated: September 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)