Chest Tube Drainage for Hemothorax

(HemoTxRCT Trial)

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: Hemodynamic instability, Penetrating injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 1 year

200 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is studying two ways to treat patients with small to moderate amounts of blood in their chest after an injury. One method uses a chest tube to drain the blood, while the other involves closely monitoring the patient to see if the blood goes away on its own. The goal is to find out which method is better for patients.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the idea that Chest Tube Drainage for Hemothorax is an effective treatment?

The available research shows that chest tube drainage is effective for treating hemothorax. One study involving 1,845 patients with traumatic hemothorax found that using a protocol with early removal of the chest tube led to a hospital stay of 48 hours or less for 81.8% of patients. Only 8.1% needed further surgery, and severe complications were rare, occurring in just 2.2% of cases. This suggests that chest tube drainage is a reliable treatment for hemothorax, helping most patients recover quickly with minimal complications. ^{1 2 3 4 5}

What safety data is available for chest tube drainage for hemothorax?

Chest tube drainage, also known as tube thoracostomy, is a common procedure used to treat conditions like hemothorax. Safety data indicates that complications can occur in 2-25% of cases, with serious complications in up to 10% of cases. Complications can be technical, such as tube malposition or dislodgement, and infective, such as empyema. The blunt dissection technique is recommended over the trocar technique due to a lower risk of complications. Proper securing of the tube connection is important to prevent dislodgement and associated risks. ^{6 7 8 9 10}

Is the treatment 'Chest tube drain' promising for hemothorax?

Yes, chest tube drain is a promising treatment for hemothorax. It helps remove blood from the chest, allowing the lungs to expand properly and aiding in stopping the bleeding. This method is commonly used and has been effective in treating various chest conditions. ^{1 2 5 11 12}

Research Team

Chad G Ball, MD

Principal Investigator

University of Calgary

Eligibility Criteria

This trial is for adults over 18 with blunt chest injuries and a hemothorax detected by CT scan. It's not for those who are unstable due to the injury, need urgent tube placement, have penetrating injuries, already have a chest tube, were admitted over 24 hours ago, or have severe chest fractures or respiratory distress from the hemothorax.

Inclusion Criteria

A hemothorax has been found in a CT scan.

I have had a chest injury without any cuts.

Exclusion Criteria

I have been in the hospital for more than 24 hours.

I have multiple broken ribs on the same side of my chest, causing instability.

My breathing problems are due to my heart condition, as my doctor says.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either chest tube drainage or expectant management for traumatic hemothorax

Up to 1 year

Regular monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Treatment Details

Interventions

• Chest tube drain
• Expectant management

Trial Overview The study compares two ways to manage traumatic hemothoraces: inserting a chest tube drain versus expectant management (close monitoring without immediate intervention). The goal is to determine when each method should be used for better patient outcomes.

Participant Groups

Group I: Chest tube drain Active Control 1 Intervention

A chest tube placed with the intent of draining all intra-pleural blood.

Group II: Expectant management Placebo Group 1 Intervention

No chest tube, but will undergo standard observation/conservative management by the trauma service.

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Alberta Health services

Collaborator

Trials

168

Recruited

658,000+

Findings from Research

Closed drainage has become an important treatment for hemothorax, allowing for better apposition of the pleura and aiding in hemostasis, which is crucial for recovery.

Video-assisted thoracic surgery (VATS) is the most effective method for draining clotted hemothorax, especially when performed early, as traditional tube thoracostomy may not be sufficient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hemothorax. Jacoby, RC., Battistella, FD.[2005]

Tube thoracostomy is a critical initial treatment for various thoracic conditions, including pneumothorax and pleural effusions, but the choice between small-bore and large-bore drains remains debated.

This review highlights the evolution of chest drains and aims to clarify the clinical indications for their use, particularly comparing the effectiveness of small-bore drains versus large-bore drains in managing pleural and thoracic diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

When size matters: changing opinion in the management of pleural space-the rise of small-bore pleural catheters. Filosso, PL., Sandri, A., Guerrera, F., et al.[2020]

A new thoracic closed drainage package was tested on 20 canines and proved to be as effective as traditional chest tubes for treating traumatic hemopneumothorax, using various evaluation methods like ultrasound and tension tests.

This new drainage system is lightweight and portable, making it potentially more suitable for emergency situations where quick treatment is essential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A portable thoracic closed drainage instrument for hemopneumothorax. Tang, H., Pan, T., Qin, X., et al.[2016]

A protocol involving vigorous physiotherapy and early removal of the thoracostomy tube led to a hospital stay of 48 hours or less for 81.8% of 1,845 patients with traumatic haemothorax, indicating effective management of the condition.

The study reported a low incidence of severe complications (2.2%), with only 0.8% developing empyema and a 1.4% mortality rate, primarily due to ongoing hemorrhage, suggesting that the short drainage protocol is both safe and effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Traumatic haemothorax--experience of a protocol for rapid turnover in 1,845 cases. Knottenbelt, JD., Van der Spuy, JW.[2006]

In a study of 803 adult patients with traumatic pneumothorax, a protocol based on air leakage and lung expansion allowed for 66.1% of those who required drainage to have their intercostal drain removed within 24 hours, leading to minimal morbidity.

The approach resulted in a mean hospital stay of just 22 hours for straightforward cases, with no deaths or empyema reported, demonstrating the safety and efficacy of this management strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Traumatic pneumothorax: a scheme for rapid patient turnover. Knottenbelt, JD., van der Spuy, JW.[2019]

The use of the Autosuture Surgiport for tube thoracostomy may enhance safety and efficiency, potentially reducing the risk of serious complications, which occur in up to 10% of traditional cases.

This technique aims to improve the insertion process of pleural drains, although specific data on outcomes or comparisons to standard methods are not provided in the abstract.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Autosuture Surgiport for pleural drain insertion. Galloway, PJ., King, PM., Freeland, P., et al.[2019]

Cross-taping is the most secure method for connecting thoracostomy tubes to chest drainage systems, significantly outperforming both straight taping and plastic bands in preventing dislodgement.

Transpore™ tape is the least effective material for securing thoracostomy connections, requiring the least force to disconnect, while Micropore™ and Soft Cloth Tape on Liner showed similar effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to secure the connection between thoracostomy tube and drainage system? Li, KK., Wong, KS., Wong, YH., et al.[2020]

In a study of 52 patients over 7 months, the overall complication rate for pleural drainage procedures was 14%, with 9% classified as major complications, highlighting the risks associated with both pre-hospital and in-hospital thoracostomy.

Of the 91 chest tubes placed, 31% were poorly positioned, indicating a need for improved training and technique assessment to reduce complications during this critical procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-hospital and in-hospital thoracostomy: indications and complications. Aylwin, CJ., Brohi, K., Davies, GD., et al.[2022]

Tube thoracostomy is a common procedure used to drain fluid from the pleural space, but it carries significant risks, including serious complications like nerve injuries and cardiac damage, especially when using the trocar technique.

The blunt dissection technique for tube thoracostomy is recommended over the trocar technique due to its lower associated complication rates, highlighting the importance of technique choice in patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tube thoracostomy: complications and its management. Kesieme, EB., Dongo, A., Ezemba, N., et al.[2023]

In a study of 15 patients with persistent air leaks from chest tube drainage, bronchoscopic injection of 5% ethanolamine oleate successfully controlled air leaks in 12 cases, demonstrating its potential efficacy as a treatment option.

The procedure was associated with some transient adverse reactions like fever and chest pain, but these resolved without complications, and patients experienced a median hospital stay of about 3 days post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bronchoscopic ethanolamine injection therapy in patients with persistent air leak from chest tube drainage. Lim, AL., Kim, CH., Hwang, YI., et al.[2021]

Tube thoracostomy is a widely used procedure in cardiothoracic surgery, and proper technique is crucial to reduce complications.

The authors propose a novel and straightforward method using a nasal speculum for chest drain insertion, which may enhance the safety and efficacy of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a nasal speculum for chest-drain insertion: a simple technique. Saxena, P., Konstantinov, IE., Newman, MA.[2018]

A modified technique of simple thoracostomy was used in 45 trauma patients as a faster and simpler alternative to conventional chest drain insertion for treating tension pneumothorax and hemothorax.

This new technique shows potential advantages in emergency situations, as it reduces the risks associated with chest drain insertion and allows for quicker stabilization of patients before hospital transport.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simple thoracostomy avoids chest drain insertion in prehospital trauma. Deakin, CD., Davies, G., Wilson, A.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Hemothorax. [2005]

2. China pubmed.ncbi.nlm.nih.gov

When size matters: changing opinion in the management of pleural space-the rise of small-bore pleural catheters. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

A portable thoracic closed drainage instrument for hemopneumothorax. [2016]

4. South Africa pubmed.ncbi.nlm.nih.gov

Traumatic haemothorax--experience of a protocol for rapid turnover in 1,845 cases. [2006]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Traumatic pneumothorax: a scheme for rapid patient turnover. [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Use of Autosuture Surgiport for pleural drain insertion. [2019]

7. China pubmed.ncbi.nlm.nih.gov

How to secure the connection between thoracostomy tube and drainage system? [2020]

8. England pubmed.ncbi.nlm.nih.gov

Pre-hospital and in-hospital thoracostomy: indications and complications. [2022]

9. Egypt pubmed.ncbi.nlm.nih.gov

Tube thoracostomy: complications and its management. [2023]

10. Korea (South) pubmed.ncbi.nlm.nih.gov

Bronchoscopic ethanolamine injection therapy in patients with persistent air leak from chest tube drainage. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Use of a nasal speculum for chest-drain insertion: a simple technique. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

Simple thoracostomy avoids chest drain insertion in prehospital trauma. [2019]