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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the best way to treat hemothorax, a condition where blood accumulates in the chest after an injury. Researchers seek to understand whether using a chest tube (thoracostomy tube) to drain the blood is always necessary or if some cases can be managed with careful monitoring alone. Participants will either receive a chest tube or be closely observed without it to evaluate which method is more effective. Individuals who have experienced a blunt chest injury and have blood in their chest detected by a CT scan may be suitable for this study. The results will guide doctors in choosing the best treatment for future patients with similar injuries. As an unphased trial, this study allows participants to contribute to important research that could enhance future treatment options for hemothorax.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that using a chest tube to remove blood from the chest, known as tube thoracostomy, is a common treatment for post-injury chest blood. However, it carries risks. Studies have found complications in 6% to 37% of cases, including procedural injuries and infections.

Some research suggests that smaller tubes can reduce complication risks. These tubes may cause fewer problems and allow quicker drainage. Despite potential risks, chest tubes remain essential for treating chest blood, especially in emergencies.

In summary, while chest tube drainage is effective, it carries risks. The decision to use this treatment often involves weighing benefits against potential complications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it compares two different approaches for managing hemothorax, which is blood accumulation in the chest cavity. The trial evaluates the effectiveness of using a chest tube to actively drain blood versus expectant management, where no chest tube is used and patients are observed and managed conservatively. The chest tube drain offers a direct method to remove blood from the pleural space, potentially speeding up recovery and reducing complications. This trial could provide insights into which method leads to better patient outcomes and helps refine treatment protocols for hemothorax.

What evidence suggests that this trial's treatments could be effective for hemothorax?

Research shows that chest tubes are commonly used to treat hemothorax, a condition where blood accumulates in the chest after an injury. In this trial, one group of participants will receive a chest tube drain to remove the blood, preventing issues like infection or further harm. However, risks such as injury and infection can occur in up to 22% of patients. Recent evidence suggests that smaller chest tubes might be as effective as larger ones and may cause fewer complications. This method could be less invasive and safer for some patients. Another group in this trial will undergo expectant management, involving standard observation without a chest tube. Overall, chest tube drainage effectively manages hemothorax, but it carries some potential risks. ^{1 2 4 6 7}

Who Is on the Research Team?

Chad G Ball, MD

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

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.

You already have a chest tube inserted.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

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]

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 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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6389558/

Chest drain and thoracotomy for chest trauma - PMC Although large-bore chest drains have been traditionally used in case of haemothorax, recent evidences seem to question this routine, showing good performances ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0735675720308226

Effectiveness and safety of small-bore tube thoracostomy ... Our study showed that the use of small-bore (≤20 Fr) chest tubes to treat traumatic hemothorax/pneumothorax achieved the purposes of tube thoracostomy.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39213292/

Small versus large-bore thoracostomy for traumatic ... We performed a systematic review to test the hypothesis that small bore tube thoracostomy (SBTT) (≤14 F) is as effective as large-bore tube thoracostomy (LBTT) ...

4. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2788397

Comprehensive Review of Chest Tube Management A meta-analysis by Chang et al demonstrated that small-bore chest tubes are associated with lower complications rates and shorter drainage ...

5. aast.org aast.org/static/be86332b-4e0e-452c-9af0ce0158b95688/T6-Pigtail-vs-Chest-Tube-in-Thoracic-Trauma-ReviewAm-Surg-2023.pdf

Outcomes of Pigtail Catheter Placement versus Chest Tube ... The primary outcome was the failure rate of drainage tubes, defined as requiring a second tube placement or VATS, unresolved pneumothorax, ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK556088/

Care of a Chest Tube - StatPearls - NCBI Bookshelf Chest tubes are a critical intervention for managing pleural space pathologies, including pneumothorax, hemothorax, empyema, and postoperative drainage.

7. emedicine.medscape.com emedicine.medscape.com/article/80678-overview

Tube Thoracostomy - Medscape Reference Large-bore drains are recommended for drainage of acute hemothorax and to monitor further blood loss.