Tissue Plasminogen ActivatorPhase 4ELEVATENCT03167281
Early Intrapleural TPA Instillation Versus Late
A Phase 4 study testing early tPA and DNase in people with Tissue Plasminogen Activator, run by Prisma Health-Midlands at 1 site in United States.
Trial summary
Chest tubes are used for air or fluid removal from the pleural space. When a chest tube is placed, it can be hard for the fluid to drain.Tissue plasminogen activator (tPA) and DNase are given through the chest tube to help with draining the fluid. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Tissue Plasminogen Activator
- What is being tested?
- early tPA and DNase
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2017to 10 Mar 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients, age 18 years or older
- Patients with an indication for a thoracostomy tube placement for a pleural effusion
Who cannot join
- Patients that require a thoracostomy tube for a pneumothorax
- Pregnant women
- Sensitivity to t-PA, or DNase
- Patients taking carbamazepine or nitroglycerin
- Lung volume reduction surgery on side of pleural effusion
Trial locations and contacts
1 site in 1 country.
United States1 site
Palmetto Health Richland
Columbia, South Carolina, 29203
About this study
Chest tubes are used for air or fluid removal from the pleural space. When a chest tube is placed, it can be hard for the fluid to drain.Tissue plasminogen activator (tPA) and DNase are given through the chest tube to help with draining the fluid. We are doing this research to see if early addition of tPA-DNase immediately after chest tube placement will help with better fluid draining.
Read the detailed description
The purpose of this study is to determine the timing and efficacy of early administration and late administration of t-PA/DNase via thoracostomy (n=60). Patients will be identified from the Intensive Care Unit, Coronary Care Unit, and wards/stepdown units. Prior to chest tube placement, patients will be randomized to one of the two treatment arms (early use of t-PA-DNase verus late use of t-PA-DNase). Route of administration will be via their thoracostomy tube over a period of three days twice daily.
- Conditions
- Tissue Plasminogen Activator
- Being tested
- early tPA and DNase
- Keywords
- Chest tube, Thoracostomy, Pleural Diseases, Lung Neoplasms, Pulmonary Embolism, Pneumothorax, Thoracic Surgery, Deoxyribonucleases, Fibrinolytic Agents, Drainage, Pleural Effusion
- Medical subject headings
- Pleural Diseases, Lung Neoplasms, Pulmonary Embolism, Pneumothorax, Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early tPA and DNaseCombination product
Early addition of tPA and DNase (immediately at chest tube placement) versus later (24-48 hours) after chest tube placement.
| Study group | Role | What they receive |
|---|---|---|
| tPA and DNase | No intervention | 10mg of t-PA and 5 mg of DNase in a 30 mL solution of water/saline administered via chest tube over three days twice daily 24-48 hours after chest tube placed. |
| Early tPA and DNase | Experimental | 10mg of t-PA and 5 mg of DNase in a 30 mL solution of water/saline administered via chest tube over three days twice daily with initial administration occurring at chest tube placement. Receives: Combination Product: early tPA and DNase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest tube removal
Time to chest tube removal
Measured: 7 days
Secondary outcomes (3)
Fluid drainage
Volume of fluid drained after each tPA and DNase instillation
Measured: 3 days
Need for other interventions
Post tPA/DNase administration, the need for other interventions, such as surgery or additional chest tube, will be determined.
Measured: 4 days
Discharge
Time to discharge
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2017
- Study start17 Feb 2017
- Primary completion10 Mar 2021
- Study completion10 Mar 2021
Why it stopped: lack of adequate recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tissue Plasminogen ActivatorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Midlands
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rohan Mankikar, MD, Principal investigator, Prisma Health-Midlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03167281
- Sponsor's protocol ID
- 00058518
- Acronym
- ELEVATE
- Status last verified
- Feb 2025
- First submitted
- 22 May 2017
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Intrapleural TPA Instillation Versus Late
- ClinicalTrials.gov ID
- NCT03167281
- Acronym / sponsor ID
- ELEVATE / 00058518
- Conditions
- Tissue Plasminogen Activator
- Keywords
- Chest tube, Thoracostomy, Pleural Diseases, Lung Neoplasms, Pulmonary Embolism, Pneumothorax, Thoracic Surgery, Deoxyribonucleases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of adequate recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Prisma Health-MidlandsUniversity, hospital or other
- Study start
- 17 Feb 2017 (actual)
- Primary completion
- 10 Mar 2021 (actual)
- Study completion
- 10 Mar 2021 (actual)
- First posted
- 25 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chest tubes are used for air or fluid removal from the pleural space. When a chest tube is placed, it can be hard for the fluid to drain.Tissue plasminogen activator (tPA) and DNase are given through the chest tube to help with draining the fluid. We are doing this research to see if early addition of tPA-DNase immediately after chest tube placement will help with better fluid draining.
Detailed description
The purpose of this study is to determine the timing and efficacy of early administration and late administration of t-PA/DNase via thoracostomy (n=60). Patients will be identified from the Intensive Care Unit, Coronary Care Unit, and wards/stepdown units. Prior to chest tube placement, patients will be randomized to one of the two treatment arms (early use of t-PA-DNase verus late use of t-PA-DNase). Route of administration will be via their thoracostomy tube over a period of three days twice daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tPA and DNase | No intervention | –10mg of t-PA and 5 mg of DNase in a 30 mL solution of water/saline administered via chest tube over three days twice daily 24-48 hours after chest tube placed. |
| Early tPA and DNase | Experimental | Combination Product: early tPA and DNase10mg of t-PA and 5 mg of DNase in a 30 mL solution of water/saline administered via chest tube over three days twice daily with initial administration occurring at chest tube placement. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients, age 18 years or older
- Patients with an indication for a thoracostomy tube placement for a pleural effusion
Key exclusion criteria (5 listed)
- Patients that require a thoracostomy tube for a pneumothorax
- Pregnant women
- Sensitivity to t-PA, or DNase
- Patients taking carbamazepine or nitroglycerin
- Lung volume reduction surgery on side of pleural effusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| early tPA and DNaseEarly addition of tPA and DNase (immediately at chest tube placement) versus later (24-48 hours) after chest tube placement. | Combination product | Early tPA and DNase |
Primary outcome
Chest tube removal
Time frame: 7 days
Time to chest tube removal
3 secondary outcomes
Fluid drainage
Time frame: 3 days
Need for other interventions
Time frame: 4 days
Discharge
Time frame: 3 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- South Carolina Research Studies DirectoryLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rohan Mankikar, MD principal investigator
Prisma Health-Midlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing early tPA and DNase in people with Tissue Plasminogen Activator, run by Prisma Health-Midlands at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chest tube removal (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.