Status:
RECRUITING
VATS Surgery Compared to Drainage in the Treatment of Pleural Empyema
Lead Sponsor:
Thomas Decker Christensen
Collaborating Sponsors:
Odense University Hospital
Rigshospitalet, Denmark
Conditions:
Pleural Empyema
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Pleura empyema is a frequent disease with a high morbidity and a mortality rate of approximately 15%. Pleura empyema is characterized by the passage of three stages (I - III). The aim of treating the...
Detailed Description
Intrapleural Fibrinolysis and DNase versus VATS for the treatment of pleural empyema: a randomized, controlled trial BACKGROUND Pleural empyema is a disease with an infection inside the chest cavity...
Eligibility Criteria
Inclusion
- 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:
- A clinical presentation compatible with pleural infection AND
- Has pleural fluid which is either:
- purulent pleural fluid or
- gram stain positive or
- culture positive or
- acidic with pH \< 7.2 or
- low pleural fluid glucose (\< 2 mmol/L) in the absence of accurate pH measurement or
- septated pleural fluid on ultrasound
Exclusion
- • 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
Key Trial Info
Start Date :
October 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2028
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT04095676
Start Date
October 30 2022
End Date
October 30 2028
Last Update
October 3 2025
Active Locations (3)
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1
Aarhus University Hospital
Aarhus, Aarhus, Denmark, 8200
2
Rigshospitalet
Copenhagen, Denmark
3
Odense University Hospital
Odense, Denmark