Intraventricular HemorrhageIVHNCT01064011
Prospective Randomized, Controlled Trial for Treatment of Intraventricular Hemorrhage
A study testing Rt-PA thrombolysis and endoscopic hematoma evacuation in people with Intraventricular Hemorrhage, run by Albany Medical College at 1 site in United States.
Trial summary
Intraventricular hemorrhage comprises about 15% of the 500,000 strokes that occur annually in the United States. In the emergent setting, patients with obstructive hydrocephalus are routinely treated with placement of an external ventricular drain. 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?
- Rt-PA thrombolysis and endoscopic hematoma evacuation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jan 2014
- Phase
- Interventional
- 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
- Age 18-75
- Radiographic evidence of intraventricular hemorrhage with hydrocephalus
- Admission Glasgow Coma Scale ≥ 5 (motor score ≥ 2)
- Placement of an external ventricular drain with an opening pressure >20 mm Hg
Who cannot join
- Intraventricular hemorrhage secondary to cerebral aneurysm, arteriovenous malformation, or tumor
- Coagulopathy (Platelet count <100,000, International normalized ratio >1.5. Reversal of warfarin is permitted.)
- Age <18 or >75
- Pregnancy (positive pregnancy test)
- Clotting disorders
- Medical contraindications to administration of general anesthesia as determined by the attending anesthesiologist
Show all 13Show fewer
- Medical contraindications to surgery as determined by the attending neurosurgeon
- Contraindication to recombinant tissue plasminogen activator administration:
- Evidence of enlargening intracranial hemorrhage as evidenced by an increase in intracranial hemorrhage volume (>5 ml) on CT obtained after EVD placement
- Internal bleeding, involving retroperitoneal sites, or the gastrointestinal, genitourinary, or respiratory tracts
- Superficial or surface bleeding, observed at vascular puncture and access sites (e.g. venous cutdowns, arterial punctures) or site of recent surgical intervention
- Evidence of cerebrospinal infection by Gram stain or culture
- Advanced directive indicating Do Not Resuscitate or Do Not Intubate status
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Albany Medical Center
Albany, New York, 12208
Yu-Hung Kuo, MD, 518-262-5088, kuo@mail.amc.edu
Tyler Kenning, MD, 518 262-5088, kennint@mail.amc.edu
About this study
Official title: A Prospective Randomized, Controlled Trial for Treatment of Intraventricular Hemorrhage: External Ventricular Drainage and Intraventricular Thrombolysis vs. External Ventricular Drainage and Endoscopic Evacuation
Intraventricular hemorrhage comprises about 15% of the 500,000 strokes that occur annually in the United States. In the emergent setting, patients with obstructive hydrocephalus are routinely treated with placement of an external ventricular drain. This study will compare the effect of external ventricular drainage plus intraventricular thrombolysis versus external ventricular drainage plus endoscopic evacuation on neurologic outcomes for patients with hydrocephalus from intraventricular hemorrhage.
- Conditions
- Intraventricular Hemorrhage
- Being tested
- Rt-PA thrombolysis, endoscopic hematoma evacuation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rt-PA thrombolysisProcedure or surgery
patients will be administered a total of six doses of rt-PA (each 1 mg/ml) through the external ventricular drain every eight hours.
endoscopic hematoma evacuationProcedure or surgery
In the operating room under general anesthesia, the external ventricular drain will be removed and the burr hole enlarged to allow for entry of the endoscope. The neuroscope will be introduced through the burr hole down the prior external ventricular drain tract into the ipsilateral ventricle. utilizing a standard technique combining gentle aspiration, continuous irrigation, and grasping forceps,the intraventricular hematoma will be evacuated. After the evacuation the endoscope will be removed and an external ventricular drain will be reattached to a closed system and permitted to drain post-operatively.
| Study group | Role | What they receive |
|---|---|---|
| External Ventricular drainage, Intraventricular Thrombolysis | Other | Not described Receives: Procedure: Rt-PA thrombolysis |
| External Ventricular Drainage and Endoscopic Evacuation | Other | Not described Receives: Procedure: endoscopic hematoma evacuation |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionJan 2014 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraventricular HemorrhageStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Albany Medical College
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01064011
- Sponsor's protocol ID
- 01
- Acronym
- IVH
- Status last verified
- Jan 2010
- First submitted
- 5 Feb 2010
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized, Controlled Trial for Treatment of Intraventricular Hemorrhage: External Ventricular Drainage and Intraventricular Thrombolysis vs. External Ventricular Drainage and Endoscopic Evacuation
- ClinicalTrials.gov ID
- NCT01064011
- Acronym / sponsor ID
- IVH / 01
- Conditions
- Intraventricular Hemorrhage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Albany Medical CollegeUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 8 Feb 2010 (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.
Intraventricular hemorrhage comprises about 15% of the 500,000 strokes that occur annually in the United States. In the emergent setting, patients with obstructive hydrocephalus are routinely treated with placement of an external ventricular drain. This study will compare the effect of external ventricular drainage plus intraventricular thrombolysis versus external ventricular drainage plus endoscopic evacuation on neurologic outcomes for patients with hydrocephalus from intraventricular hemorrhage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| External Ventricular drainage, Intraventricular Thrombolysis | Other | Procedure: Rt-PA thrombolysis |
| External Ventricular Drainage and Endoscopic Evacuation | Other | Procedure: endoscopic hematoma evacuation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-75
- Radiographic evidence of intraventricular hemorrhage with hydrocephalus
- Admission Glasgow Coma Scale ≥ 5 (motor score ≥ 2)
- Placement of an external ventricular drain with an opening pressure >20 mm Hg
Key exclusion criteria (13 listed)
- Intraventricular hemorrhage secondary to cerebral aneurysm, arteriovenous malformation, or tumor
- Coagulopathy (Platelet count <100,000, International normalized ratio >1.5. Reversal of warfarin is permitted.)
- Age <18 or >75
- Pregnancy (positive pregnancy test)
- Clotting disorders
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 |
|---|---|---|
| Rt-PA thrombolysispatients will be administered a total of six doses of rt-PA (each 1 mg/ml) through the external ventricular drain every eight hours. | Procedure or surgery | External Ventricular drainage, Intraventricular Thrombolysis |
| endoscopic hematoma evacuationIn the operating room under general anesthesia, the external ventricular drain will be removed and the burr hole enlarged to allow for entry of the endoscope. The neuroscope will be introduced through the burr hole down the prior external ventricular drain tract into the ipsilateral ventricle. utilizing a standard technique combining gentle aspiration, continuous irrigation, and grasping forceps,the intraventricular hematoma will be evacuated. After the evacuation the endoscope will be removed and an external ventricular drain will be reattached to a closed system and permitted to drain post-operatively. | Procedure or surgery | External Ventricular Drainage and Endoscopic Evacuation |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2011.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rt-PA thrombolysis and endoscopic hematoma evacuation in people with Intraventricular Hemorrhage, run by Albany Medical College 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 4 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: status not confirmed, as of the sponsor's last update on 27 Jun 2011. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Hung Kuo, MD (518 262-5088, kuoy@mail.amc.edu), or a site near the patient. 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 27 Jun 2011.