Health TrialsbyHealthPanel

Trial of Reduced Alteplase Dose for Parapneumonic Effusion (TRAPPE)

ConditionPleural Infection
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese University of Hong Kong

About this trial

Objectives: A pilot study to assess the feasibility of a randomization trial protocol comparing low (2.5mg) and standard (10mg) doses of intrapleural tissue plasminogen activator (tPA) with deoxyribonucleases (DNase) in unresolved pleural infection.

Hypothesis: The proposed randomized protocol comparing low dose and standard doses of intrapleural tPA (with DNase) therapy will be feasible and acceptable.

Design and subjects: A single-center, two-arm, double-blinded, randomized controlled feasibility study which includes subjects with unresolved pleural infection eligible for intrapleural tPA/DNase injection, with follow-ups till 3 months after hospital discharge.

Interventions: Recruited subjects will be randomized in 1:1 ratio to receive a maximum of 6 doses of intrapleural tPA (with DNase) starting at either 2.5mg or 10mg. A clinical decision is allowed at or after the third dose of tPA to continue with the assigned regimen (blinded) or convert to open-label use of 10mg doses of tPA to complete the course based on the clinical response.

Main outcome measures: The main outcome is the feasibility of the trial protocol, based on the percentage of eligible patients enrolled, retained to discharge, and completing 3 months of follow-up. Other important outcomes include survival at 3 months follow-up and without the need for surgical intervention, the need for additional pleural interventions, the number of decisions to convert to open-labelled use of 10mg intrapleural tPA, clinical and radiographic response after the treatment course, safety profiles, especially bleeding complications and the number and reason for protocol violation.

Data analysis and expected results: Feasibility outcomes will be reported as descriptive data. Comparison of outcomes between the two treatment groups will be analyzed on an intention-to-treat basis. Safety outcomes will be reported descriptively for each group. The reported estimates of recruitment rates, adherence, follow-up completeness, and variability and event rates for key clinical and bleeding outcomes will be used, to inform the design and sample size considerations future studies incorporating the current study design

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinical features suggesting uncontrolled pleural infection with incomplete drainage of pleural effusion, at least 1 day after insertion of pleural drain (French size 12 or above) and administration of antibiotics.

Intend to administer intrapleural fibrinolytic

Written informed consent obtained

Disqualifiers

Previously received intrapleural tPA to the ipsilateral pleural space for the current episode of pleural infection.

Known sensitivity to tPA or DNase.

A coincidental stroke, major haemorrhage or major trauma.

Frank bleeding or evidence of puncture to the intercostal artery during chest drain insertion.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Tissue Plasminogen Activator

    Drug

    Intrapleural administration of tissue plasminogen activator

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Low dose tPAExperimental treatment 1 intervention
Group B: Standard dose tPAActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Study feasibility

Study feasibility based on \>50% of eligible patients being successfully randomized, \>95% of randomized participants retained to discharge, and \>80% of randomized participants

Time frame
90 days

Secondary outcomes

1

Treatment success

survival at 90 days and without the need for surgical intervention following the initial dose of tPA/DNase (at randomization)

Time frame
90 days
2

need for additional pleural interventions

The need for additional pleural interventions (therapeutic thoracentesis, chest drain insertion, surgical referral) for failed medical treatment

Time frame
90 days
3

Open use of intrapleural 10mg tPA

Number of patients reverted to open intrapleural 10mg tPA after the second dose of tPA treatment

Time frame
3 days
4

Bleeding events

Non-significant and significant bleedings due to tPA use

Time frame
90 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chinese University of Hong Kong

Lead sponsor

Source ClinicalTrials.gov
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