Alteplase Through an Indwelling Pleural Catheter for the Management of Symptomatic Septated Malignant Pleural Effusion

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

This study investigates whether alteplase can help to improve pleural fluid drainage and dyspnea (breathlessness) in patients with non-draining malignant pleural effusion. Alteplase helps dissolve blood clots and is used to treat heart attacks, strokes, and clots in the lungs. Alteplase may help to control symptoms of breathlessness.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Referral to pulmonary services for inability to drain fully via IPC

Presence of a symptomatic septated pleural effusion

Chest radiograph: effusion filling >= 1/3 of the hemithorax, or

Computed tomography (CT)-scan: AP depth of the effusion >= 1/3 of the AP dimension on the axial image superior to the hemidiaphragm, including atelectatic lung surrounded by effusion, or

Disqualifiers

Inability to provide informed consent

Uncorrectable coagulopathy based on criteria followed by cardiopulmonary center for procedures.

Active bleeding

Known allergic reaction to thrombolytics

Trial design

Design model

Single group

Treatments tested in this trial

  • Alteplase

    Biological/Vaccine

    Instilled into IPC

  • Placebo Administration

    Drug

    Instilled into IPC

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Arm I (alteplase)Experimental treatment 1 intervention
Group B: Arm II (placebo)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events

Time frame
through study completion; an average of 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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