Phase 4
Completed N=27
Intrapleural Fibrinolytic Therapy to Enhance Chemical Pleurodesis Enhance Chemical Pleurodesis
Source: ClinicalTrials.gov NCT04806373 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcomePrimary: Chest X-ray Results on Day 3 After Pleurodesis — 5; 6; 5; 8 Participants — p=0.863
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Prospective Randomized Double-Blind Controlled Trial of Intrapleural Fibrinolytic Therapy to Enhance Chemical Pleurodesis versus Standard of care Talc therapy in patients with recurrent pleural effusion.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Chest X-ray Results on Day 3 After Pleurodesis |
5; 6; 5; 8; 2; 1 | 0.863 |
| SECONDARY Pleural Drainage Volume (mL) After Pleurodesis |
125; 427.5; 39; 150; 45; 100 | 0.005 sig |
| SECONDARY Dyspnea on Day 3 After Pleurodesis |
1; 1 | 0.891 |
| SECONDARY Pain Score |
10; 10 | 0.899 |
| SECONDARY Chest Tube Size |
4; 4; 4; 4; 2; 2 | 0.809 |
| SECONDARY Time to Chest Tube Removal |
7; 9 | 0.946 |
| SECONDARY Length of Stay |
10; 11 | 0.808 |
| SECONDARY Radiographically Satisfactory Pleurodesis |
8; 12 | 0.662 |
| SECONDARY Time to Achieve Radiographically Satisfactory Pleurodesis |
5.75; 4.83 | 0.714 |
| SECONDARY 30 Day Mortality |
4; 5 | 1.0 |
Eligibility Criteria
Inclusion Criteria
- Age > 18 years
- Symptomatic pleural effusion requiring intervention
- Expected survival > 3 months
- Written informed consent to trial participation
Exclusion Criteria
- Females who are pregnant or lactating
- Inability to obtain consent from the patient or patient's designated representative.
- Inability of the patient to comply with the protocol.
- Previously documented adverse reaction to talc or cathflo activase.
- Oral or intravenous steroid therapy
Data sourced from ClinicalTrials.gov (NCT04806373). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.