What side effects are associated with this type of intervention?

Chest tube drainage, a common treatment for hemothorax, involves mechanically removing blood from the chest cavity. Known side effects of this procedure include injury to surrounding tissues, infection, and other complications in up to 22% of patients. These complications can range from minor infections to more severe issues such as damage to internal organs or persistent bleeding.

What prior FDA approvals exist?

The primary FDA-approved treatment for hemothorax, particularly for the mechanical removal of blood from the chest cavity, is chest tube drainage (tube thoracostomy). This method involves inserting a tube into the pleural space to evacuate accumulated blood, thereby preventing complications such as infection and lung compression. While there are no specific drugs approved solely for hemothorax, the procedure itself is a standard and widely accepted intervention in trauma care.

What other types of research exist?

Promising novel alternatives to chest tube drainage for hemothorax patients include conservative management with close monitoring for small to moderate hemothoraces, as some studies suggest these can be absorbed without intervention. Additionally, advancements in minimally invasive techniques, such as video-assisted thoracoscopic surgery (VATS), may offer effective management with fewer complications compared to traditional chest tube drainage.

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Tube Thoracostomy

Chest Tube Drainage for Hemothorax (HemoTxRCT Trial)

N/A

Recruiting

Led By Chad G Ball, MD

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >= 18 years

Blunt thoracic injury

Must not have

Ipsilateral flail chest fracture pattern

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days after patients recruited in the study

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Chest tube drainage can lead to complications such as organ injury and infections in some patients. Expectant management avoids these risks but may delay necessary treatment if the condition worsens.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

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I have had a chest injury without any cuts.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days after patients recruited in the study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days after patients recruited in the study

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days after patients recruited in the study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The numbers of hemothoraces that require thoracic interventions.

Secondary study objectives

The days of intensive care unit stay

Mechanical ventilation

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Chest tube drainActive Control1 Intervention

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

Group II: Expectant managementPlacebo Group1 Intervention

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

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Chest tube drainage is a primary treatment for hemothorax, involving the insertion of a tube into the pleural cavity to mechanically remove accumulated blood. This procedure helps re-expand the lung, improve breathing, and prevent complications such as infection or fibrothorax. Timely and effective removal of blood is crucial for reducing morbidity and mortality in hemothorax patients.