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New treatment option for Hematopoietic and Lymphoid Cell Neoplasm
Official title Alteplase Through an Indwelling Pleural Catheter for the Management of Symptomatic Septated Malignant Pleural Effusion
ClinicalTrials.gov ID: NCT06184321
What this study is testing
What is Alteplase?
Alteplase is an investigational medicine, being studied as a potential treatment for hematopoietic and lymphoid cell neoplasm.
Also referred to as Activase, Plasminogen Activator (Human Tissue-Type Protein Moiety).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, 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
- Referral to pulmonary services for inability to drain fully via IPC
- Presence of a symptomatic septated pleural effusion
- A pleural effusion of significant moderate to large volume based on:
- 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...
You likely can't join if
- Inability to provide informed consent
- Study subject has any disease or condition that interferes with safe completion of the study including:
- Uncorrectable coagulopathy based on criteria followed by cardiopulmonary center for procedures.
- Active bleeding
- Known allergic reaction to thrombolytics
- Pleural effusion is smaller than expected on bedside pre-procedure ultrasound
See the full eligibility criteria
- Referral to pulmonary services for inability to drain fully via IPC
- Presence of a symptomatic septated pleural effusion
- A pleural effusion of significant moderate to large volume based on:
- 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
- Ultrasound: effusion spanning at least three intercostal spaces, with a \>= 3 cm in at least one intercostal space, while the patient sits upright
- Age \> 18
- Borg score \>= 3
- Absence of a blocked IPC as demonstrated by a flush with 20 cc of saline x1 without resistance
- Presence of septated effusion based on ultrasound (US) and chest CT
- Inability to provide informed consent
- Study subject has any disease or condition that interferes with safe completion of the study including:
- Uncorrectable coagulopathy based on criteria followed by cardiopulmonary center for procedures.
- Active bleeding
- Known allergic reaction to thrombolytics
- Pleural effusion is smaller than expected on bedside pre-procedure ultrasound
- No septations and/or no loculations on bedside pre-procedure ultrasound
- Patient is asymptomatic
- Blocked IPC as determined by saline flush
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to 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 Houston, Texas, United States. 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.