An interventional study of Alteplase and Placebo in Pleural Effusion Associated With Pulmonary Infection and Bacterial Pleural Effusion Other Than Tuberculosis, sponsored by Midwest Pulmonary and Critical Care. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-04-30.
Sponsored by Midwest Pulmonary and Critical Care · Not applicable, Interventional, and Treatment
The purpose of this study is to document the efficacy and safety of intrapleural instillation of Activase vs Placebo in the management of complicated pleural effusions and empyemas
The current treatments available for complicated pleural effusions (CPE) include chest tube placement for drainage and IV antibiotics. If this fails and CPE occurs then in most patients thoracotomy is performed. Patients that are not surgical candidates have image guided catheter placement performed, sometimes multiple times. The American College of Chest Physicians (ACCP) formed a CPE panel and published guidelines for treating CPE. Percutaneous image-guided drainage is the most common approach for CPE. The panel recognizes the cumulative data that supports the use of fibrinolytics, VATS, and thoracotomy. The CPE panel acknowledged the lack of randomized clinical trials to determine efficacy and safety of these modalities in CPE and strongly encourages the research to take place.
Fibrinolytic therapy is a relatively noninvasive, easy to use, and is relatively inexpensive. If successful, it will prevent sepsis and septic shock, decrease hospital stay, morbidity and mortality and prevent any surgical procedures. Multiple doses of fibrinolytics have been used in CPE with no evidence of systemic anti-fibrinolytic activity. Complications with these medications are also very uncommon and only isolated instances are reported. The benefit from successful pleural drainage using these agents will decrease morbidity, mortality, surgical procedures, and hospital stay.
38 studies on the registry are indexed under Empyema; 11 are open to participants now.
This study's enrollment of 100 is close to the median of 92 across 28 interventional studies indexed under Empyema.
Browse Empyema studies →This is the only study on the registry with Midwest Pulmonary and Critical Care as lead sponsor.
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Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Either 25 mg of Alteplase or Placebo instilled daily. Response to therapy after three days. cross over to the other drug if no response was noted.
Drug: Alteplase · Drug: Placebo
If the first arm fails then the 2nd arm ( cross over to either Placebo or Alteplase not used in the first arm) instilled intrapleurally daily for three days
Drug: Alteplase · Drug: Placebo
25 Mg of Alteplase in 100 cc of normal saline was instilled intrapeurally for daily for three days
Placebo in 100 cc of normal saline was instilled intrapleurally daily for three days
Also known as: TPA, Activase
No Surgical Intervention
CT scans of the chest and Chest X rays (CXR) were used to determine resolution of Pleural effusions/empyema/ pneumonia after 3 days of Alteplase/ Placebo therapy. If no response was noted with the first intervention patients were offered surgery --Decortiation/ Video Assisted Thoracic Surgery (VATS) or to receive the second intervention. Patients that failed the second intervention were offered surgery.
Time frame: patients were followed six weeks per protocol. Most patients treated with Alteplase were also followed for up to six months
Number of Participants With Pneumonia That Responded to Therapy
patients were followed for 6 weeks and CXR and CT scan were done to document resolution of pneumonia
Time frame: 6 weeks
Number of Participants With Pleural Effusion/Empyema That Responded to Therapy
patients were followed for 6 weeks and CXR and CT scan were done to document resolution of pleural effusion/empyema
Time frame: 6 weeks
Number of Participants With Shortness of Breath That Responded to Therapy
patients were followed for 6 weeks and clinical symptoms of resolution of shortness of breath were documented
Time frame: 6 weeks
Number of Participants With Clinical Symptoms of Sepsis That Responded to Therapy
patients were followed for 6 weeks and resolution of sepsis was documented
Time frame: 6 weeks
Patients with loculated pleural effusions that failed to respond to chest tube placement and standard medical treatment and were considered for surgery were given the option to enter into a double blind cross over trial
| Milestone | Alteplase Then Placebo | Placebo Then Alteplase |
|---|---|---|
| Started | 54 | 46 |
| Completed | 45 | 45 |
| Not completed | 9 | 1 |
| Withdrew: Protocol violation | 2 | 1 |
| Withdrew: Bleeding at chest tube site--first dose | 1 | 0 |
| Withdrew: Died within 3 weeks | 1 | 0 |
| Withdrew: Malposition/blocked chest tube tube | 2 | 0 |
| Withdrew: Large lung mass with minimal effusion | 1 | 0 |
| Withdrew: Associated prolonged pneumothorax | 1 | 0 |
| Withdrew: Trapped lung | 1 | 0 |
| Milestone | Alteplase Then Placebo | Placebo Then Alteplase |
|---|---|---|
| Started | 8 | 41 |
| Completed | 3 | 37 |
| Not completed | 5 | 4 |
| Withdrew: Withdrawal by subject | 5 | 2 |
| Withdrew: Discarded for malposition of chest tube | 0 | 2 |
CT scans of the chest and Chest X rays (CXR) were used to determine resolution of Pleural effusions/empyema/ pneumonia after 3 days of Alteplase/ Placebo therapy. If no response was noted with the first intervention patients were offered surgery --Decortiation/ Video Assisted Thoracic Surgery (VATS) or to receive the second intervention. Patients that failed the second intervention were offered surgery.
| participants | Alteplase | Placebo |
|---|---|---|
| No Surgical Intervention | 66 | 6 |
patients were followed for 6 weeks and CXR and CT scan were done to document resolution of pneumonia
No measurements were reported for this outcome.
patients were followed for 6 weeks and CXR and CT scan were done to document resolution of pleural effusion/empyema
No measurements were reported for this outcome.
patients were followed for 6 weeks and clinical symptoms of resolution of shortness of breath were documented
No measurements were reported for this outcome.
patients were followed for 6 weeks and resolution of sepsis was documented
No measurements were reported for this outcome.
Collected over soon after drug instillation and for the first 24 hours in the hospital and then followed up for six months. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Received Alteplase Only | — | 1/42 (2.4%) | 10/42 (23.8%) |
| Received Placebo Only | — | 0/8 (0%) | 5/8 (62.5%) |
| Received Both Alteplase and Placebo | — | 0/40 (0%) | 8/40 (20%) |
| Event | Received Alteplase Only | Received Placebo Only | Received Both Alteplase and Placebo |
|---|---|---|---|
| serious bleeding at the chest tube siteSkin and subcutaneous tissue disorders | 1/42 | 0/8 | 0/40 |
| Shortness of breath, worsening sepsisGeneral disorders | 0/42 | 0/8 | 0/40 |
| Event | Received Alteplase Only | Received Placebo Only | Received Both Alteplase and Placebo |
|---|---|---|---|
| increasing shortness of breathRespiratory, thoracic and mediastinal disorders | 0/42 | 2/8 | 0/40 |
| worsening sepsisInfections and infestations | 0/42 | 2/8 | 0/40 |
| mild to moderate chest painGeneral disorders | 6/42 | 1/8 | 3/40 |
| hypotension and worsening renal functionGeneral disorders | 0/42 | 0/8 | 4/40 |
| blood loss--pleural fluidBlood and lymphatic system disorders | 3/42 | 0/8 | 0/40 |
| severe chest pain post drug instillationGeneral disorders | 1/42 | 0/8 | 1/40 |
| Age, Categorical(Participants) | Alteplase; Placebo |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 39 |
| >=65 years | 61 |
| Age Continuous(years) | Alteplase; Placebo |
|---|---|
| Mean | 67 ± 15 |
| Sex: Female, Male(Participants) | Alteplase; Placebo |
|---|---|
| Female | 36 |
| Male | 64 |
| Region of Enrollment(participants) | Alteplase; Placebo |
|---|---|
| United States | 100 |
This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tissue Plasminogen Activator