NCT03468933

Fibrinolysis Compared to Thoracoscopy for Pleural Infection

Completed Phase 4 Results posted Last updated 4 February 2021

What this trial tests

Phase 4 trial testing tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) in Pleural Infection in 32 participants. Completed in 30 December 2019.

Timeline

1 November 2017

Primary endpoint
30 December 2019

30 December 2019

Quick facts

Lead sponsor	Tulane University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	32
Start date	1 November 2017
Primary completion	30 December 2019
Estimated completion	30 December 2019
Sites	1 location across United States

Drugs / interventions tested

• tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) — full drug profile →
• Medical Thoracoscopy

Conditions studied

• Pleural Infection — all drugs for Pleural Infection →
• Empyema — all drugs for Empyema →
• Pleural Diseases — all drugs for Pleural Diseases →
• Parapneumonic Effusion — all drugs for Parapneumonic Effusion →

Sponsor

Tulane University

Who can join

18 and older, any sex, with Pleural Infection or Empyema. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Duration of Hospital Stay After Intervention Primary · 12 week follow up period

duration of hospital stay in days from time of procedure to discharge from hospital.

Group	Value	95% CI
Fibrinolytic Therapy Group	4	4 – 5.5
Medical Thoracoscopy Group	2	2 – 5

Total Length of Hospital Stay Secondary · 12 week follow up period

Total days spent in the hospital

Group	Value	95% CI
Fibrinolytic Therapy Group	6	5 – 8.5
Medical Thoracoscopy Group	3.5	2 – 10

Number of Participants Necessitating Intervention After the Assigned Treatment Secondary · 12 week follow up period

1. Need for surgical intervention (VATS, Open Thoracotomy) in any arm 2. Need for additional chest tube and/or fibrinolytic therapy in the medical thoracoscopy arm due to treatment failure 3. Need of additional chest tube or additional fibrinolytic doses in the fibrinolytic therapy arm due to treatment failure

Group	Value	95% CI
Fibrinolytic Therapy Group	3
Medical Thoracoscopy Group	4

Adverse Events Secondary · 12 week follow up period

any Adverse events (pain, bleeding)

Group	Value	95% CI
Fibrinolytic Therapy Group	1
Medical Thoracoscopy Group	1

In Hospital and 30-day Mortality Secondary · 30 days

Death of a patient while being hospitalized or up to 30 days after

Group	Value	95% CI
Fibrinolytic Therapy Group	0
Medical Thoracoscopy Group	1

Adverse events — posted to ClinicalTrials.gov

Time frame: The perioperative period until hospital discharge, an average of 4 weeks per participant. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Fibrinolytic Therapy Group

Serious: 0/16 (0%)

Deaths: 0/16

Medical Thoracoscopy Group

Serious: 0/16 (0%)

Deaths: 1/16

Other adverse events (1 terms — click to expand)

Reaction	System	Fibrinolytic Therapy Group	Medical Thoracoscopy Group
Respiratory	Respiratory, thoracic and mediastinal disorders	—	—

Data from ClinicalTrials.gov NCT03468933 adverse events section.

Sponsor's own description

The purpose of this prospective randomized clinical trial is to compare two currently accepted standard-of-care treatment strategies: Medical thoracoscopy as compared to instillation of intrapleural tissue Plasminogen Activator (TPA) and human recombinant Deoxyribonuclease (DNase) for the management of empyema or complicated parapneumonic effusion (CPPE) in adults.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Medical thoracoscopy treatment for pleural infections: a systematic review and meta-analysis.
   Mondoni M, Saderi L, Trogu F, Terraneo S, et al · · 2021 · cited 34× · PMID 33879116 · DOI 10.1186/s12890-021-01492-9
2. Pleuroscopy or video-assisted thoracoscopic surgery for exudative pleural effusion: a comparative overview.
   Ali MS, Light RW, Maldonado F. · · 2019 · cited 25× · PMID 31463153 · DOI 10.21037/jtd.2019.03.86