Subarachnoid HemorrhagePhase 1/2NCT01878136
Effect of Intraventricular tPA Following Aneurysmal Subarachnoid Hemorrhage
A Phase 1/2 study testing Tissue Plasminogen Activator in people with Subarachnoid Hemorrhage and Cerebral Vasospasm, run by Rush University Medical Center at 1 site in United States.
Trial summary
This study will evaluate the hypothesis that the administration of intraventricular tPA reduces the rates of cerebral vasospasm and ventriculoperitoneal shunt-dependent hydrocephalus in patients with aneurysmal subarachnoid hemorrhage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage, Cerebral Vasospasm, Cerebral Aneurysm
- What is being tested?
- Tissue Plasminogen Activator
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Sep 2016
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 18 years old.
- SAH due to aneurysm, as determined by CT angiogram or cerebral angiogram.
- Modified Fisher (mF) grade 3 or 4 SAH, defined as thick cisternal blood without (grade 3) or with (grade 4) intraventrciular blood.
- Exclusion of the aneurysm from the parent circulation by endovascular embolization (Raymond class I or II) within 48 hours of ictus.
- Ventriculostomy placement must occur prior to randomization.
- Informed consent obtained from the patient or patient's decision maker
Who cannot join
- Determination by treating physician(s) that no ventriculostomy is needed.
- Presence of intrinsic clotting disorders (e.g. due to hepatic failure, nephrotic syndrome, etc). Subjects whose pharmacologic anticoagulation is reversed, as determined by PT/INR, PTT within our institution's normal range, will be permitted to participate in this study.
- Presence of significant anemia, defined as hemoglobin < 8 gm/dL.
- Patients who undergo endovascular techniques requiring post-operative dual anti-platelet therapy.
- Residual aneurysm sac filling (Raymond class III occlusion).
- Aneurysm or vessel perforation during the endovascular procedure.
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- Presence of craniectomy.
- Significant neurologic disability prior to the onset of SAH.
- Determination that administration of tPA/placebo cannot be initiated within 72 hours of symptom onset.
- Presence of untreated intracranial aneurysms larger than 3mm on CT angiography or cerebral angiogram.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
This study will evaluate the hypothesis that the administration of intraventricular tPA reduces the rates of cerebral vasospasm and ventriculoperitoneal shunt-dependent hydrocephalus in patients with aneurysmal subarachnoid hemorrhage.
- Being tested
- Tissue Plasminogen Activator
- Medical subject headings
- Subarachnoid Hemorrhage, Vasospasm, Intracranial, Intracranial Aneurysm, Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue Plasminogen ActivatorDrug
Also called Activase, Alteplase
Dose: 1mg Q8 x 12 doses, or until clearance of blood from ventricles and cisterns Administration: intraventricular administration (through external ventricular drain)
| Study group | Role | What they receive |
|---|---|---|
| Intraventricular tPA | Active comparator | Tissue Plasminogen Activator (tPA)
Dose: 1 mg Q8 hr x 12 doses, or until blood is cleared from the ventricles and cisterns Adminstration: Intraventricular; via previously placed external ventricular drain Receives: Drug: Tissue Plasminogen Activator |
| Placebo | Placebo comparator | Placebo
Dose 1 mL sterile saline Receives: Drug: Tissue Plasminogen Activator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Primary Outcome
The composite primary outcome will consist of the rates of ventriculoperitoneal shunt (VPS) placement, clinically significant vasospasm, and death. VPS placement serves as surrogate measure of hydrocephalus. These outcomes will be measured during the patient's hospitalization.
Measured: 1-60 days after SAH
Secondary outcomes (2)
Rate of new intracranial hemorrhage
New intracranial hemorrhage will be defined as any new parenchymal or ventricular hemorrhage occurring after the first dose of study drug/placebo.
Measured: 1-14 days after SAH
Rate of intracranial infection
The presence of infection will require identification of an offending organism via CSF cultures.
Measured: 1-14 after SAH
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2013 (estimated)
- Study startMar 2015
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
Why it stopped: Time constraints
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephan Munich, Rush University Medical Center
- Investigators
- Stephan Munich, MD, Principal investigator, Rush University Medical Center, Department of NeurosurgeryRoham Moftakhar, MD, Study director, Rush University Medical Center, Department of Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01878136
- Sponsor's protocol ID
- 13011803
- Status last verified
- Nov 2015
- First submitted
- 12 Jun 2013
- Last updated
- 11 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraventricular tPA Following Aneurysmal Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT01878136
- Acronym / sponsor ID
- 13011803
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Time constraints
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 14 Jun 2013 (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 study will evaluate the hypothesis that the administration of intraventricular tPA reduces the rates of cerebral vasospasm and ventriculoperitoneal shunt-dependent hydrocephalus in patients with aneurysmal subarachnoid hemorrhage.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intraventricular tPA | Active comparator | Drug: Tissue Plasminogen ActivatorTissue Plasminogen Activator (tPA) Dose: 1 mg Q8 hr x 12 doses, or until blood is cleared from the ventricles and cisterns Adminstration: Intraventricular; via previously placed external ventricular drain |
| Placebo | Placebo comparator | Drug: Tissue Plasminogen ActivatorPlacebo Dose 1 mL sterile saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age greater than 18 years old.
- SAH due to aneurysm, as determined by CT angiogram or cerebral angiogram.
- Modified Fisher (mF) grade 3 or 4 SAH, defined as thick cisternal blood without (grade 3) or with (grade 4) intraventrciular blood.
- Exclusion of the aneurysm from the parent circulation by endovascular embolization (Raymond class I or II) within 48 hours of ictus.
- Ventriculostomy placement must occur prior to randomization.
Key exclusion criteria (10 listed)
- Determination by treating physician(s) that no ventriculostomy is needed.
- Presence of intrinsic clotting disorders (e.g. due to hepatic failure, nephrotic syndrome, etc). Subjects whose pharmacologic anticoagulation is reversed, as determined by PT/INR, PTT within our institution's normal range, will be permitted to participate in this study.
- Presence of significant anemia, defined as hemoglobin < 8 gm/dL.
- Patients who undergo endovascular techniques requiring post-operative dual anti-platelet therapy.
- Residual aneurysm sac filling (Raymond class III occlusion).
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 |
|---|---|---|
| Tissue Plasminogen ActivatorAlso: Activase, AlteplaseDose: 1mg Q8 x 12 doses, or until clearance of blood from ventricles and cisterns Administration: intraventricular administration (through external ventricular drain) | Drug | Intraventricular tPA, Placebo |
Primary outcome
Composite Primary Outcome
Time frame: 1-60 days after SAH
The composite primary outcome will consist of the rates of ventriculoperitoneal shunt (VPS) placement, clinically significant vasospasm, and death. VPS placement serves as surrogate measure of hydrocephalus. These outcomes will be measured during the patient's hospitalization.
2 secondary outcomes
Rate of new intracranial hemorrhage
Time frame: 1-14 days after SAH
Rate of intracranial infection
Time frame: 1-14 after SAH
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 11 Nov 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.
Stephan Munich, MD principal investigator
Rush University Medical Center, Department of Neurosurgery
Roham Moftakhar, MD study director
Rush University Medical Center, Department of Neurosurgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tissue Plasminogen Activator in people with Subarachnoid Hemorrhage and Cerebral Vasospasm, run by Rush University Medical Center 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 6 inclusion and 10 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 11 Nov 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 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?
Composite Primary Outcome (time frame: 1-60 days after SAH). 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 11 Nov 2015.