Cerebral HemorrhagePhase 2NCT00029315
Intraventricular Rt-PA in Patients With Intraventricular Hemorrhage
A Phase 2 study testing Recombinant Tissue Plasminogen Activator (rt-PA) in people with Cerebral Hemorrhage, run by Johns Hopkins University at 1 site in United States.
Trial summary
This is a study to evaluate how recombinant tissue plasminogen activator (rt-PA) is utilized in patients with intraventricular hemorrhage (IVH). rt-PA is a drug that has been shown to dissolve blood, and may allow intraventricular catheters to be more effective for a longer period of time. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cerebral Hemorrhage
- What is being tested?
- Recombinant Tissue Plasminogen Activator (rt-PA)
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2001to Sep 2004
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Intraventricular hemorrhage (IVH) confirmed by CT scan
- More than 12 hours post bleed
- Hematoma size stable by CT scan
- Post-IVH catheter CT scan
- Able to begin study within 24 hours of bleed
Who cannot join
- Infratentorial bleed
- Supratentorial bleed greater than 30 cc
- Unclipped aneurysm suspected
- Arteriovenous malformation suspected
- Any severe, complicating illness (e.g., AIDS or DNR)
- Cardiovascular parameters that could confound study (e.g., myocardial infarction, pulmonary emboli, systemic fibrinolysis)
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- Active internal bleeding
- Requirement for heparin doses greater than 10,000 U/day
- Concurrent coumadin
- Known allergy to rt-PA
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
The Johns Hopkins University
Baltimore, Maryland, 21287
About this study
Official title: Intraventricular Rt-PA Pharmacokinetic and Pharmacodynamic Study
This is a study to evaluate how recombinant tissue plasminogen activator (rt-PA) is utilized in patients with intraventricular hemorrhage (IVH). rt-PA is a drug that has been shown to dissolve blood, and may allow intraventricular catheters to be more effective for a longer period of time.
Read the detailed description
IVH occurs in about 40 percent of intracerebral hemorrhage cases and 15 percent of aneurysmal subarachnoid hemorrhage cases. Evidence supports a strong contribution of IVH to morbidity and mortality after cerebral hemorrhage. External ventricular drainage (EVD) is required clinical management; however, EVD via intraventricular catheter alone fails to prevent much of the morbidity and mortality of IVH. This study seeks to demonstrate the safety and efficacy of intraventricular thrombolysis, using rt-PA, as a method of removing this blood and altering morbidity and mortality. Patients will receive intraventricular injections of rt-PA or placebo every 12 hours. They will be followed prospectively with daily head CT scans during the acute-treatment phase and again between Days 28 and 32.
Completion date provided represents the completion date of the grant per OOPD records
- Conditions
- Cerebral Hemorrhage
- Being tested
- Recombinant Tissue Plasminogen Activator (rt-PA)
- Keywords
- Intraventricular hemorrhage, Subarachnoid hemorrhage, Intracerebral hemorrhage, Pharmacokinetics, Recombinant Proteins, Anticoagulants, Tissue Plasminogen Activator, Pharmacology, Catheters, Indwelling, Cerebral Ventricles
- Medical subject headings
- Cerebral Hemorrhage, Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Tissue Plasminogen Activator (rt-PA)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2002 (estimated)
- Study startSep 2001
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00029315
- Sponsor's protocol ID
- FD-R-2018-01
- Other IDs
- FD-R-002018-01
- Status last verified
- Dec 2001
- First submitted
- 10 Jan 2002
- Last updated
- 25 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraventricular Rt-PA Pharmacokinetic and Pharmacodynamic Study
- ClinicalTrials.gov ID
- NCT00029315
- Acronym / sponsor ID
- FD-R-2018-01
- Conditions
- Cerebral Hemorrhage
- Keywords
- Intraventricular hemorrhage, Subarachnoid hemorrhage, Intracerebral hemorrhage, Pharmacokinetics, Recombinant Proteins, Anticoagulants, Tissue Plasminogen Activator, Pharmacology
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Sep 2001
- Study completion
- Sep 2004
- First posted
- 11 Jan 2002 (estimated)
- 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.
This is a study to evaluate how recombinant tissue plasminogen activator (rt-PA) is utilized in patients with intraventricular hemorrhage (IVH). rt-PA is a drug that has been shown to dissolve blood, and may allow intraventricular catheters to be more effective for a longer period of time.
Detailed description
IVH occurs in about 40 percent of intracerebral hemorrhage cases and 15 percent of aneurysmal subarachnoid hemorrhage cases. Evidence supports a strong contribution of IVH to morbidity and mortality after cerebral hemorrhage. External ventricular drainage (EVD) is required clinical management; however, EVD via intraventricular catheter alone fails to prevent much of the morbidity and mortality of IVH. This study seeks to demonstrate the safety and efficacy of intraventricular thrombolysis, using rt-PA, as a method of removing this blood and altering morbidity and mortality. Patients will receive intraventricular injections of rt-PA or placebo every 12 hours. They will be followed prospectively with daily head CT scans during the acute-treatment phase and again between Days 28 and 32.
Completion date provided represents the completion date of the grant per OOPD records
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Intraventricular hemorrhage (IVH) confirmed by CT scan
- More than 12 hours post bleed
- Hematoma size stable by CT scan
- Post-IVH catheter CT scan
- Able to begin study within 24 hours of bleed
Key exclusion criteria (11 listed)
- Infratentorial bleed
- Supratentorial bleed greater than 30 cc
- Unclipped aneurysm suspected
- Arteriovenous malformation suspected
- Any severe, complicating illness (e.g., AIDS or DNR)
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 |
|---|---|---|
| Recombinant Tissue Plasminogen Activator (rt-PA) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant Tissue Plasminogen Activator (rt-PA) in people with Cerebral Hemorrhage, run by Johns Hopkins University 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 5 inclusion and 11 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: finished, as of the sponsor's last update on 25 Mar 2015. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 25 Mar 2015.