Comparing VATS surgery and drainage for treating pleural empyema
Official title: Intrapleural Fibrinolysis and DNase Versus VATS for the Treatment of Pleural Empyema: a Randomized, Controlled Trial
Run by Aarhus University Hospital · NCT04095676 · Data updated 2026-11-12
This study is testing whether a type of surgery called VATS works better than standard drainage methods for helping patients with pleural empyema feel better and recover their lung function.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 184 (estimated) |
| Sponsor | Aarhus University Hospital Academic / other |
| Locations | 3 sites (Aarhus, Aarhus and 2 other locations) |
| Status | Recruiting |
| Started | October 30, 2022 |
| Main results expected | October 30, 2027 |
| Study ends | October 30, 2028 |
| Registry record updated | October 3, 2025 |
| Trial ID | NCT04095676 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older who have been hospitalized with a diagnosis of community-acquired pleural infection.
✕Probably not a fit
Patients who are pregnant, breastfeeding, terminally ill, or have had previous intrathoracic surgery within the last year may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the effectiveness of Video Assisted Thoracoscopic Surgery (VATS) compared to standard drainage methods for patients with pleural empyema, particularly in stages II and III of the disease. The study will involve randomizing participants to receive either VATS or drainage with intrapleural fibrinolytic therapy. The goal is to determine which treatment provides better outcomes in terms of infection removal and lung expansion. The trial is being conducted at multiple hospitals in Denmark, focusing on patients who have been hospitalized for acute pleural infections.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with pleural empyema, potentially reducing morbidity and mortality rates.
How similar studies have gone: Previous studies have shown positive effects of combining fibrinolytic therapy with DNase, but the comparison of VATS to drainage in this context is still under clinical evaluation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:
* 18 years or more on the day of hospitalization
* Must be able to provide informed consent
* Acute hospitalization within the last 48 hours
* Meeting diagnostic criteria for community acquired pleural infection using the following criteria:
1. A clinical presentation compatible with pleural infection AND
2. Has pleural fluid which is either:
1. purulent pleural fluid or
2. gram stain positive or
3. culture positive or
4. acidic with pH \< 7.2 or
5. low pleural fluid glucose (\< 2 mmol/L) in the absence of accurate pH measurement or
6. septated pleural fluid on ultrasound
Exclusion Criteria:
* • Pregnancy. Prior to inclusion of fertile women (defined as the period from menarche to postmenopause) a negative pregnancy test must be available
* Breastfeeding
* Declared terminally ill or a predicted survival of less than 3 months
* Previous intrathoracic surgery (within \<1 year on the same side of the thorax as where the parapneumonic effusion/pleural empyema is located
* Previously (within \<1 year) hospitalized with with complex parapneumonic effusion (stage II) or pleural empyema (stage III)
* Drainage during the current admission on the same side of the thorax (excluding diagnostic pleural puncture)
* Hospitalization within 7 days prior to current hospitalization
* Previous allergic reaction to alteplase or DNase
* Use of alteplase therapy contraindicated:
* Ongoing treatment with oral anticoagulant incl. new oral anticoagulants (e.g. warfarin (Marevan), Dabigatranetexilat (Pradaxa), Rivaroxaban (Xarelto), Apixaban (Eliquis), Endoxaban (Lixiana))
* Significant ongoing bleeding or within last six months
* Known haemorrhagic diathesis
* Previous or suspected intracranial hemorrhage
* Suspected subarachnoidal hemorrhage or condition following subarachnoidal hemorrhage from aneurysm
* All forms of damage to the central nervous system (e.g. cerebral tumors, aneurysm, intracranial / spinal surgery)
* Recent (within 10 days) cardiac resuscitation, birth, or perforation of non-compressible blood vessel (e.g. puncture of v. subclavia, v. jugularis)
* Severe, uncontrolled arterial hypertension
* Bacterial endocarditis, pericarditis
* Acute pancreatitis
* Documented ulcerative gastrointestinal disease within last 3 months, esophagal varices, arterial aneurysm, arterio-venous malformations
* Tumor / malignancy with an increased risk of hemorrhage
* Severe liver disease, including liver failure cirrhosis, portal hypertension (esophagal varices), and active hepatitis
* Large operation or significant trauma within previous 3 months
Where it's running
-
Aarhus University Hospital
Aarhus, Aarhus, Denmark Recruiting -
Odense University Hospital
Odense, Denmark Recruiting -
Rigshospitalet
Copenhagen, Denmark Not yet recruiting
Study contacts
- Principal investigator: Christian B Laursen, MD, PhD — Odense University Hospital
- Study coordinator: Thomas D Christensen, MD, PhD
- Email: tdc@clin.au.dk
- Phone: 24778857
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.