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SuspendedNCT04525365Updated Sep 22, 2023

Pleural Suction Additional to Thoracostomy Tube for Traumatic Hemothorax

An interventional study of Pleural aspiration in Traumatic Hemothorax, sponsored by Hospital Pablo Tobón Uribe. Suspended at 1 site in Colombia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-22.

Sponsored by Hospital Pablo Tobón Uribe · Not applicable, Interventional, and Treatment

Why this study was suspended
It was not possible to achieve adequate recruitment to complete the necessary sample. The rate at which patients are recruited does not allow for continued participation
Phase
Not applicable
Study type
Interventional
Enrollment
250
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

Read the detailed description

Traumatic hemothorax is a common emergency and is commonly the result of trauma, both blunt and penetrating. Although closed drainage thoracostomy is commonly adequate for the initial management of a hemothorax in most cases, failure of the closed thoracostomy and formation of clotted hemothorax can occur in up to 5 to 30% of cases. This complication requires surgical treatment and can generate an empyema, which is a serious infection.

Therefore, the investigators want to impact through a simple and low-cost procedure such as traumatic hemothorax aspiration in the adult population, prior to insertion and fixation of the thoracostomy tube under sedation, to evacuate all the hemothorax present, thus reducing the formation of clots in these patients, and the probability of clotted hemothorax.

Methods: Initially, all patients with penetrating or closed chest trauma that came to the emergency department, are evaluated clinically and with a chest x-ray. With this information, the investigators diagnose patients with traumatic hemothorax or hemopneumothorax, and if is a candidate for drainage with closed thoracostomy. The patient will receive a dose of prophylactic antibiotic, which will be 2 gr of first-generation Cephalosporin, or 600mg iv of Clindamycin for patients allergic to penicillin. At the time of performing the closed thoracostomy procedure, and after approval and signing of the informed consent for the study by the patient or his family member in charge, a consecutive number is assigned with prior randomization of each of the groups in EPIDAT 4.0. In case of being an intervention group, a superficial sedation of the patient will be carried out in the emergency department. Moderate sedation or conscious sedation is performed. The pleura is opened and a sterile adult Yankauer plastic suction cannula (Plus-vital, CE0197, Greetmed RPC) is inserted with closed suction. The cannula will be directed towards the posterior costodiaphragmatic recess at which point hemothorax aspiration will begin at -80 cubic centimeters of water (ccH2O) until complete evacuation is achieved. At the end of the suction, the hemithorax cannula is removed and a silicone 32 French (Fr) thoracostomy tube is inserted, which is subsequently fixed with a non-absorbable 0-gauge suture. The chest tube is connected to a 3-bottle thoracic drainage system ( Oasis Dry suction Water seal 3600 single collection) without continuous pleural suction. After the procedure, a control chest X-ray will be performed within 3 hours to verify the position of the tube, hemothorax drainage, and lung expansion. The clinical and radiological follow up, will be made by surgeon criteria, until the patient develop a clotted hemothorax or is discharged. The investigators will follow this patients by phone after a month. Description and treatment of any adverse events will be made.

Analysis of each of the variables will be carried out in the two groups. Chi2 test to establish statistical significance of these differences, with a bivariate analysis.

Registry of data will be made by the investigators, the source will be the clinical records, and the month phone call, will be made by secondary investigators.

Sample size is of 250 participants, and is planned for 20 months.

02

Conditions studied

  • Traumatic Hemothorax

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03

In context

Hemothorax

26 studies on the registry are indexed under Hemothorax; 5 are open to participants now.

This study's planned enrollment of 250 is above the median of 100 across 21 interventional studies indexed under Hemothorax.

Browse Hemothorax studies →

Lead sponsor

Hospital Pablo Tobón Uribe is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Traumatic hemothorax that needs a Thoracostomy tube procedure

Exclusion criteria

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
  • for sedation
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
250 participants (estimated)

Study arms

  • Experimental
    Pleural aspiration

    Pleural aspiration under sedation

    Procedure: Pleural aspiration

  • Active comparator
    Closed Thoracostomy

    Actual management

    Procedure: Pleural aspiration

Interventions

  • ProcedurePleural aspiration

    Pleural aspiration

    Also known as: Closed Thoracostomy

06

What researchers measure

Primary outcomes

  1. Clotted hemothorax

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

    Time frame: One month

  2. Empyema

    Rate of empyema found after Thoracostomy tube procedure

    Time frame: One month

Secondary outcomes

  1. Pleural aspiration procedure complications

    Describe the percentage of patients with complications associated with the pleural aspiration procedure in patients scheduled for thoracostomy tube procedure

    Time frame: One month

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Study locations

1 site
  • Pablo Tobon Uribe Hospital
    Medellin, Antioquia 050034, Colombia
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References and documents

Publications

  • 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. PubMed 22856496 ↗
  • 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. PubMed 18716687 ↗
  • 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. PubMed 23433600 ↗
  • 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. PubMed 22310111 ↗
  • 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. PubMed 26815469 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — We not consider to share the participant data by laws in our country

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2020 (actual). Primary completion is estimated for Mar 2024, 47 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 11, 2020
First posted
Aug 25, 2020
StartActual
Mar 17, 2020
Primary completionEst.
Mar 5, 2024
CompletionEst.
Jul 31, 2024
Last update
Sep 22, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04525365
Lead sponsor
Hospital Pablo Tobón Uribe
Responsible party
Sponsor
First posted
Aug 25, 2020
Start date
Mar 17, 2020
Primary completion
Mar 5, 2024 (estimated)
Completion
Jul 31, 2024 (estimated)
Last update
Sep 22, 2023

Study contacts

Willfredy Castano, MD
principal investigator · Pablo Tobon Uribe Hospital, Thoracic Surgeon

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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