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Compares treatment options for Pleural Empyema
Official title VATS Surgery Compared to Drainage in the Treatment of Pleural Empyema
ClinicalTrials.gov ID: NCT04095676
What this study is testing
- What it's testing
- 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).
- Time commitment: about 3 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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)
See the full eligibility 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:
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Aarhus, Aarhus, Denmark
- Copenhagen, Denmark
- Odense, Denmark
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aarhus, Aarhus, Denmark; Copenhagen, Denmark; Odense, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.