Intraventricular HemorrhagePhase 2CLEAR IVHNCT00650858
Clinical Trial on Treatment of Intraventricular Hemorrhage
A Phase 2 study testing tissue plasminogen activator, rt-PA (thrombolytic) (Cathflo) in people with Intraventricular Hemorrhage, run by Johns Hopkins University at 25 sites in 4 countries.
Trial summary
The specific objective of this trial is to determine the lowest dose and dose frequency possible with the best pharmacokinetic and safety profile and it's ability to remove a blood clot from the ventricular system. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Intraventricular Hemorrhage
- What is being tested?
- tissue plasminogen activator, rt-PA (thrombolytic) (Cathflo)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 25 sitesin 4 countries
- Study dates
- Feb 2004to Aug 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age 18-75
- IVC placed as standard of care using less than or equal to 2 complete passes.
- Spontaneous ICH less than or equal to 30 cc.
- Able to receive first dose within 48 hours of CT scan diagnosing IVH (providing the time of symptom onset to diagnostic CT does not exceed 12 hours).
- Clot size measured on CT scan done 6 hours after IVC placement must be equal to the presentation clot size plus or minus 5 cc (as determined by the AxBxC)/2 method).
- ON stability CT scan either the 3rd or 4th ventricles are occluded with blood (no evidence of CSF flow on CT).
- SBP < 200 mmHg sustained for 6 hours.
- Historical Rankin of 0 or 1.
Who cannot join
- Suspected or untreated aneurysm or AVM (unless ruled out by angiogram or MRA/MRI).
- Clotting disorders.
- Patients with platelet count < 100,000, INR > 1.7, PT > 15s, or an elevated APTT.
- Pregnancy (positive pregnancy test).
- Infratentorial hemorrhage (i.e., parenchymal/posterior fossa hematoma; all cerebellar hematomas excluded).
- SAH (An angiogram should be obtained when the diagnostic CT scan demonstrates subarachnoid hemorrhage or any hematoma location or appearance not strongly associated with hypertension. If the angiogram does not demonstrate a bleeding source that accounts for the hemorrhage, the patient is eligible for the study).
Show all 13Show fewer
- ICH enlargement during the 6-hour stabilization period (6 hour after IVC placement).
- Internal bleeding, involving retroperitoneal sites, or the gastrointestinal, genitourinary, or respiratory tracts.
- Superficial or surface bleeding, observed mainly at vascular puncture and access sites (e.g., venous cutdowns, arterial punctures) or site of recent surgical intervention.
- Known risk for embolization, including history of left heart thrombus, mitral stenosis with atrial fibrillation, acute pericarditis, and subacute bacterial endocarditis.
- Prior enrollment in the study.
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
- Participation in another simultaneous medical investigation or trial.
Trial locations and contacts
25 sites in 4 countries.
25 sites in 4 countries
United States22 sites
Albany Medical Center
Albany, New York, 12208
University of Maryland Medical Systems
Baltimore, Maryland, 21202
Johns Hopkins University
Baltimore, Maryland, 21287
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Virginia, Charlottesville
Charlottesville, Virginia, 22908
University of Cincinnati
Cincinnati, Ohio, 45267
Wayne State University
Detroit, Michigan, 48201
Henry Ford Hospital
Detroit, Michigan, 48202
INOVA Fairfax Medical Center
Fairfax, Virginia, 22042
Hartford Hospital
Hartford, Connecticut, 06102
Baylor College of Medicine
Houston, Texas, 77030
CR Drew Medical Center
Los Angeles, California, 90059
Loyola University Medical Center
Maywood, Illinois, 60153
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Mt. Sinai Medical Center
New York, New York, 10029
Standford Medical Center
Palo Alto, California, 94394
Temple University
Philadelphia, Pennsylvania, 19140
Virginia Commonwealth University
Richmond, Virginia, 23298
University of Texas HSC, San Antonio
San Antonio, Texas, 78229
St. Louis University
St Louis, Missouri, 63110
Via Christi Regional Medical Center
Wichita, Kansas, 67214
United Kingdom1 site
Newcastle General Hospital
Newcastle upon Tyne, NE4 6BE
About this study
Official title: Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage (IVH)
The specific objective of this trial is to determine the lowest dose and dose frequency possible with the best pharmacokinetic and safety profile and it's ability to remove a blood clot from the ventricular system.
Read the detailed description
The purpose of this trial is to determine the efficacy and pharmacokinetics of intraventricular injections of multiple low doses of rt-PA. Sixteen subjects were already randomized to receive intraventricular injections of with 0.3 mg or 1.0 mg of rt-PA every 12 hours for up to 8 doses. Results of this stage (n=16) were then analyzed and the most effective dose of 1.0 mg was chosen to be used in the second stage (n=36) to determine the optimal frequency of dosing. We propose to test if this intervention facilitates more rapid clot resolution, complete recovery function and decreased mortality from this condition.
- Conditions
- Intraventricular Hemorrhage
- Being tested
- tissue plasminogen activator, rt-PA (thrombolytic) (Cathflo)
- Keywords
- Intraventricular hemorrhage (IVH), rt-PA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tissue plasminogen activator, rt-PA (thrombolytic) (Cathflo)Drug
Also called rt-PA, Cathflo, Activase
0.3 mg and 1.0 mg of rt-PA (Cathflo) were administered every 12 hours (dose finding) and every 8 hours (dose frequency) via the intraventricular catheter to treat intraventricular hemorrhage.
| Study group | Role | What they receive |
|---|---|---|
| 0.3 mg rt-PA | Active comparator | In stage 1 of the protocol, dose finding, subjects were randomized to either this 0.3 mg dose arm or the 1.0 mg dose arm. Subjects in this arm (0.3 mg) received up to 8 doses of 0.3 mg rt-PA every 12 hours through the intraventricular catheter to treat intraventricular hemorrhage. Receives: Drug: tissue plasminogen activator, rt-PA (thrombolytic) (Cathflo) |
| 1.0 mg rt-PA | Active comparator | In stage 1 of the protocol, dose finding, subjects were randomized to either this 1.0 mg dose arm or the 0.3 mg dose arm. Subjects in this arm (1.0 mg) received up to 8 doses of 1.0 mg rt-PA every 12 hours through the intraventricular catheter to treat intraventricular hemorrhage. Receives: Drug: tissue plasminogen activator, rt-PA (thrombolytic) (Cathflo) |
| 1.0 mg Rt-PA q8h | Experimental | In stage 2 of the protocol, dose frequency, subjects received up to 8 doses of 1.0 mg of rt-PA (Cathflo) every 8 hours through the intraventricular catheter to treat intraventricular hemorrhage. Receives: Drug: tissue plasminogen activator, rt-PA (thrombolytic) (Cathflo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day Mortality
The number of subjects who died at or before the 30-day follow-up visit were determined as a measure of safety. If more than 50% of the subjects died at or before the 30-day follow-up visit, the study would have been stopped for full DSMB review.
Measured: 30 days
Incidence of Bacterial Ventriculitis, Meningitis
The incidence of bacterial ventriculitis/meningitis was recorded to determine the safety of intraventricular administration of rt-PA. If 30% or more subjects experienced this event, the study would have been stopped for full DSMB review.
Measured: 30 days
Rate of Symptomatic Bleeding Events
The rate of symptomatic brain bleeding events were recorded to determine the safety of intraventricular administrations of rt-PA. If 35% or more subjects experienced a symptomatic bleeding event prior to the 30-day follow-up visit, the study would have been stopped for a full DSMB review.
Measured: 30-days
Secondary outcomes (5)
Average Daily Percentage Clot Size Resolution Over the First 3 Days
Daily IVH clot volume resolution, as a percentage of stability CT IVH volume, averaged over the first 3 days, determined by CT scans
Measured: 3 days
90 Day Follow-Up Modified Rankin Scale (mRS) Score
90 day follow-up visit mRS score. The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 to 6: 0. No Symptoms, 1. No Significant Disability, 2. Slight Disability, 3. Moderate Disability, 4. Moderately Severe Disability, 5. Severe Disability and 6. Dead.
(Stage 1 patients only had 30 day scores, Stage 2 patients had 30 day, 90 day and 180 day scores collected)
Measured: 90 days
90 Day Follow-Up Glasgow Outcome Scale (GOS) Score
90 day follow-up visit GOS score. The GOS is a scale used to determine the degree of recovery from patients with brain injury. There are five categories: 1. Dead, 2. Vegetative State, 3. Severe Disability, 4. Moderate Disability and 5. Good Recovery.
(Stage 1 patients only had 30 day scores, Stage 2 patients had 30 day, 90 day and 180 day scores collected)
Measured: 90 days
180 Day Follow-Up Modified Rankin Scale (mRS) Score
180 day follow-up visit mRS score. The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 to 6: 0. No Symptoms, 1. No Significant Disability, 2. Slight Disability, 3. Moderate Disability, 4. Moderately Severe Disability, 5. Severe Disability and 6. Dead.
(Stage 1 patients only had 30 day scores, Stage 2 patients had 30 day, 90 day and 180 day scores collected)
Measured: 180 days
180 Day Follow-Up Glasgow Outcome Scale (GOS) Score
180 day follow-up visit GOS score. The GOS is a scale used to determine the degree of recovery from patients with brain injury. There are five categories: 1. Dead, 2. Vegetative State, 3. Severe Disability, 4. Moderate Disability and 5. Good Recovery.
(Stage 1 patients only had 30 day scores, Stage 2 patients had 30 day, 90 day and 180 day scores collected)
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2008 (estimated)
- Study startFeb 2004
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Intraventricular 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- FDA Office of Orphan Products Development, Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Daniel F Hanley, MD, Study chair, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00650858
- Sponsor's protocol ID
- IVH05
- Other IDs
- ISRCTN47341677
- Acronym
- CLEAR IVH
- Status last verified
- Nov 2017
- First submitted
- 26 Dec 2007
- Last updated
- 11 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Kornbluth J, Nekoovaght-Tak S, Ullman N, Carhuapoma JR, Hanley DF, Ziai W. Early Quantification of Hematoma Hounsfield Units on Noncontrast CT in Acute Intraventricular Hemorrhage Predicts Ventricular Clearance after Intraventricular Thrombolysis. AJNR Am J Neuroradiol. 2015 Sep;36(9):1609-15. doi: 10.3174/ajnr.A4393. Epub 2015 Jul 30.
PubMed 26228884Ziai W, Moullaali T, Nekoovaght-Tak S, Ullman N, Brooks JS, Morgan TC, Hanley DF. No exacerbation of perihematomal edema with intraventricular tissue plasminogen activator in patients with spontaneous intraventricular hemorrhage. Neurocrit Care. 2013 Jun;18(3):354-61. doi: 10.1007/s12028-013-9826-1.
PubMed 23463422Morgan TC, Dawson J, Spengler D, Lees KR, Aldrich C, Mishra NK, Lane K, Quinn TJ, Diener-West M, Weir CJ, Higgins P, Rafferty M, Kinsley K, Ziai W, Awad I, Walters MR, Hanley D; CLEAR and VISTA Investigators. The Modified Graeb Score: an enhanced tool for intraventricular hemorrhage measurement and prediction of functional outcome. Stroke. 2013 Mar;44(3):635-41. doi: 10.1161/STROKEAHA.112.670653. Epub 2013 Jan 31.
PubMed 23370203Webb AJ, Ullman NL, Mann S, Muschelli J, Awad IA, Hanley DF. Resolution of intraventricular hemorrhage varies by ventricular region and dose of intraventricular thrombolytic: the Clot Lysis: Evaluating Accelerated Resolution of IVH (CLEAR IVH) program. Stroke. 2012 Jun;43(6):1666-8. doi: 10.1161/STROKEAHA.112.650523. Epub 2012 Apr 3.
PubMed 22474059Ziai WC, Muschelli J, Thompson CB, Keyl PM, Lane K, Shao S, Hanley DF. Factors affecting clot lysis rates in patients with spontaneous intraventricular hemorrhage. Stroke. 2012 May;43(5):1234-9. doi: 10.1161/STROKEAHA.111.641050. Epub 2012 Mar 1.
PubMed 22382155Herrick DB, Ziai WC, Thompson CB, Lane K, McBee NA, Hanley DF. Systemic hematologic status following intraventricular recombinant tissue-type plasminogen activator for intraventricular hemorrhage: the CLEAR IVH Study Group. Stroke. 2011 Dec;42(12):3631-3. doi: 10.1161/STROKEAHA.111.625749. Epub 2011 Sep 22.
PubMed 21940973
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage (IVH)
- ClinicalTrials.gov ID
- NCT00650858
- Acronym / sponsor ID
- CLEAR IVH / IVH05
- Conditions
- Intraventricular Hemorrhage
- Keywords
- Intraventricular hemorrhage (IVH), rt-PA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- FDA Office of Orphan Products Development, Genentech, Inc.
- Study start
- Feb 2004
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 2 Apr 2008 (estimated)
- Results
- Posted 17 Jul 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The specific objective of this trial is to determine the lowest dose and dose frequency possible with the best pharmacokinetic and safety profile and it's ability to remove a blood clot from the ventricular system.
Detailed description
The purpose of this trial is to determine the efficacy and pharmacokinetics of intraventricular injections of multiple low doses of rt-PA. Sixteen subjects were already randomized to receive intraventricular injections of with 0.3 mg or 1.0 mg of rt-PA every 12 hours for up to 8 doses. Results of this stage (n=16) were then analyzed and the most effective dose of 1.0 mg was chosen to be used in the second stage (n=36) to determine the optimal frequency of dosing. We propose to test if this intervention facilitates more rapid clot resolution, complete recovery function and decreased mortality from this condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0.3 mg rt-PA | Active comparator | Drug: tissue plasminogen activator, rt-PA (thrombolytic) (Cathflo)In stage 1 of the protocol, dose finding, subjects were randomized to either this 0.3 mg dose arm or the 1.0 mg dose arm. Subjects in this arm (0.3 mg) received up to 8 doses of 0.3 mg rt-PA every 12 hours through the intraventricular catheter to treat intraventricular hemorrhage. |
| 1.0 mg rt-PA | Active comparator | Drug: tissue plasminogen activator, rt-PA (thrombolytic) (Cathflo)In stage 1 of the protocol, dose finding, subjects were randomized to either this 1.0 mg dose arm or the 0.3 mg dose arm. Subjects in this arm (1.0 mg) received up to 8 doses of 1.0 mg rt-PA every 12 hours through the intraventricular catheter to treat intraventricular hemorrhage. |
| 1.0 mg Rt-PA q8h | Experimental | Drug: tissue plasminogen activator, rt-PA (thrombolytic) (Cathflo)In stage 2 of the protocol, dose frequency, subjects received up to 8 doses of 1.0 mg of rt-PA (Cathflo) every 8 hours through the intraventricular catheter to treat intraventricular hemorrhage. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18-75
- IVC placed as standard of care using less than or equal to 2 complete passes.
- Spontaneous ICH less than or equal to 30 cc.
- Able to receive first dose within 48 hours of CT scan diagnosing IVH (providing the time of symptom onset to diagnostic CT does not exceed 12 hours).
- Clot size measured on CT scan done 6 hours after IVC placement must be equal to the presentation clot size plus or minus 5 cc (as determined by the AxBxC)/2 method).
Key exclusion criteria (13 listed)
- Suspected or untreated aneurysm or AVM (unless ruled out by angiogram or MRA/MRI).
- Clotting disorders.
- Patients with platelet count < 100,000, INR > 1.7, PT > 15s, or an elevated APTT.
- Pregnancy (positive pregnancy test).
- Infratentorial hemorrhage (i.e., parenchymal/posterior fossa hematoma; all cerebellar hematomas excluded).
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 activator, rt-PA (thrombolytic) (Cathflo)Also: rt-PA, Cathflo, Activase0.3 mg and 1.0 mg of rt-PA (Cathflo) were administered every 12 hours (dose finding) and every 8 hours (dose frequency) via the intraventricular catheter to treat intraventricular hemorrhage. | Drug | 0.3 mg rt-PA, 1.0 mg Rt-PA q8h, 1.0 mg rt-PA |
Primary outcome
30-day Mortality
Time frame: 30 days
The number of subjects who died at or before the 30-day follow-up visit were determined as a measure of safety. If more than 50% of the subjects died at or before the 30-day follow-up visit, the study would have been stopped for full DSMB review.
Incidence of Bacterial Ventriculitis, Meningitis
Time frame: 30 days
The incidence of bacterial ventriculitis/meningitis was recorded to determine the safety of intraventricular administration of rt-PA. If 30% or more subjects experienced this event, the study would have been stopped for full DSMB review.
Rate of Symptomatic Bleeding Events
Time frame: 30-days
The rate of symptomatic brain bleeding events were recorded to determine the safety of intraventricular administrations of rt-PA. If 35% or more subjects experienced a symptomatic bleeding event prior to the 30-day follow-up visit, the study would have been stopped for a full DSMB review.
5 secondary outcomes
Average Daily Percentage Clot Size Resolution Over the First 3 Days
Time frame: 3 days
90 Day Follow-Up Modified Rankin Scale (mRS) Score
Time frame: 90 days
90 Day Follow-Up Glasgow Outcome Scale (GOS) Score
Time frame: 90 days
180 Day Follow-Up Modified Rankin Scale (mRS) Score
Time frame: 180 days
180 Day Follow-Up Glasgow Outcome Scale (GOS) Score
Time frame: 180 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26228884Kornbluth J, Nekoovaght-Tak S, Ullman N, Carhuapoma JR, Hanley DF, Ziai W. Early Quantification of Hematoma Hounsfield Units on Noncontrast CT in Acute Intraventricular Hemorrhage Predicts Ventricular Clearance after Intraventricular Thrombolysis. AJNR Am J Neuroradiol. 2015 Sep;36(9):1609-15. doi: 10.3174/ajnr.A4393. Epub 2015 Jul 30.
- Derived from this study: PubMed 23463422Ziai W, Moullaali T, Nekoovaght-Tak S, Ullman N, Brooks JS, Morgan TC, Hanley DF. No exacerbation of perihematomal edema with intraventricular tissue plasminogen activator in patients with spontaneous intraventricular hemorrhage. Neurocrit Care. 2013 Jun;18(3):354-61. doi: 10.1007/s12028-013-9826-1.
- Derived from this study: PubMed 23370203Morgan TC, Dawson J, Spengler D, Lees KR, Aldrich C, Mishra NK, Lane K, Quinn TJ, Diener-West M, Weir CJ, Higgins P, Rafferty M, Kinsley K, Ziai W, Awad I, Walters MR, Hanley D; CLEAR and VISTA Investigators. The Modified Graeb Score: an enhanced tool for intraventricular hemorrhage measurement and prediction of functional outcome. Stroke. 2013 Mar;44(3):635-41. doi: 10.1161/STROKEAHA.112.670653. Epub 2013 Jan 31.
- Derived from this study: PubMed 22474059Webb AJ, Ullman NL, Mann S, Muschelli J, Awad IA, Hanley DF. Resolution of intraventricular hemorrhage varies by ventricular region and dose of intraventricular thrombolytic: the Clot Lysis: Evaluating Accelerated Resolution of IVH (CLEAR IVH) program. Stroke. 2012 Jun;43(6):1666-8. doi: 10.1161/STROKEAHA.112.650523. Epub 2012 Apr 3.
- Derived from this study: PubMed 22382155Ziai WC, Muschelli J, Thompson CB, Keyl PM, Lane K, Shao S, Hanley DF. Factors affecting clot lysis rates in patients with spontaneous intraventricular hemorrhage. Stroke. 2012 May;43(5):1234-9. doi: 10.1161/STROKEAHA.111.641050. Epub 2012 Mar 1.
- Derived from this study: PubMed 21940973Herrick DB, Ziai WC, Thompson CB, Lane K, McBee NA, Hanley DF. Systemic hematologic status following intraventricular recombinant tissue-type plasminogen activator for intraventricular hemorrhage: the CLEAR IVH Study Group. Stroke. 2011 Dec;42(12):3631-3. doi: 10.1161/STROKEAHA.111.625749. Epub 2011 Sep 22.
- CLEAR III WebsiteLink provided by the sponsor.
Related trials for Intraventricular Hemorrhage
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
The Correlation Between Red Cell Transfusion and Complications of Prematurity
Retinopathy of Prematurity (ROP), Bronchopulmonary Dysplasia (BPD)
Enrolling by invitationObservational study
Intelligent Physiological Monitoring to Predict Preterm Brain Injury
Cerebral Palsy (CP), Intraventricular Hemorrhage Neonatal
Active, not recruiting
Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants
IVH- Intraventricular Hemorrhage, Extreme Prematurity
Active, not recruiting
aSAH Treatment Based on Intraventricular ICP Monitoring: A Prospective, Multicenter, Randomized and Controlled Trial
Aneurysmal Subarachnoid Hemorrhage, Intacranial Hypertension
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.
Daniel F Hanley, MD study chair
Johns Hopkins University
25 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tissue plasminogen activator, rt-PA (thrombolytic) (Cathflo) in people with Intraventricular Hemorrhage, run by Johns Hopkins University at 25 sites in 4 countries.
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 8 inclusion and 13 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 11 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Canada, Germany, United Kingdom. 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?
Yes. Results are posted in the registry (first posted 17 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
30-day Mortality (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00650858, which also lists 6 linked publications.
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 Dec 2017.