Hypertensive Intracerebral HemorrhageNCT03452722
Neuroinflammatory Response in Patients With ICH and IVH Treated With rtPA
An observational study of Hypertensive Intracerebral Hemorrhage and Intraventricular Hemorrhage, run by University of Rijeka.
Trial summary
This study compares the neuroinflammatory response in patients with hypertensive ICH associated with IVH treated with intraventriculary applied rtPA, and the control group. The inflammatory mediator concentration is analyzed in local cerebrospinal liquor. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertensive Intracerebral Hemorrhage, Intraventricular Hemorrhage, Brain Injuries
- What is being tested?
- intraventricual recombinant tissue plasminogen activator application
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2011to 1 Sep 2018
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All subjects from 18 to 80 years.
Who may be able to join
- Subjects with primary ICH with IVH
- ICH score 2-4, , with origin of the hematoma in the basal ganglia and blood in the third and/or ventricle
- Patient is not considered a surgical candidate by neurosurgery service
Who cannot join
- No history of diseases or drugs that affect the immunological system.
- ICH score 1 and 5
- Current participation in another research drug treatment protocol
- Previously known intracranial arteriovenous malformation or aneurysms
- Intracerebral hematoma considered to be related to trauma
- ICH is located in the pons
- Blood in the subarachnoid space visualized on CT scan
About this study
This study compares the neuroinflammatory response in patients with hypertensive ICH associated with IVH treated with intraventriculary applied rtPA, and the control group. The inflammatory mediator concentration is analyzed in local cerebrospinal liquor.
- Being tested
- intraventricual recombinant tissue plasminogen activator application
- Keywords
- secondary brain injury, neuroinflammation
- Medical subject headings
- Intracranial Hemorrhage, Hypertensive, Brain Injuries, Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraventricual recombinant tissue plasminogen activator applicationDrug
| Study group | Role | What they receive |
|---|---|---|
| Study group | Applied rtPA Receives: Drug: intraventricual recombinant tissue plasminogen activator application | |
| Control study | rtPA not applied |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytokine concentration difference between two groups
Cytokine concentration measured from CSL
Measured: Samples taken on day 0, day 1, day 3 and day 7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start1 Jun 2011
- Primary completion1 Aug 2017
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hypertensive Intracerebral 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rijeka
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matija Sošić, University of Rijeka
- Investigators
- Vlatka Sotosek Tokmadzic, PhD, Study director, University of Rijeka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03452722
- Sponsor's protocol ID
- 13.06.1.1.12
- Status last verified
- Mar 2019
- First submitted
- 25 Feb 2018
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hanley DF, Lane K, McBee N, Ziai W, Tuhrim S, Lees KR, Dawson J, Gandhi D, Ullman N, Mould WA, Mayo SW, Mendelow AD, Gregson B, Butcher K, Vespa P, Wright DW, Kase CS, Carhuapoma JR, Keyl PM, Diener-West M, Muschelli J, Betz JF, Thompson CB, Sugar EA, Yenokyan G, Janis S, John S, Harnof S, Lopez GA, Aldrich EF, Harrigan MR, Ansari S, Jallo J, Caron JL, LeDoux D, Adeoye O, Zuccarello M, Adams HP Jr, Rosenblum M, Thompson RE, Awad IA; CLEAR III Investigators. Thrombolytic removal of intraventricular haemorrhage in treatment of severe stroke: results of the randomised, multicentre, multiregion, placebo-controlled CLEAR III trial. Lancet. 2017 Feb 11;389(10069):603-611. doi: 10.1016/S0140-6736(16)32410-2. Epub 2017 Jan 10.
PubMed 28081952Dunatov S, Antoncic I, Bralic M, Jurjevic A. Intraventricular thrombolysis with rt-PA in patients with intraventricular hemorrhage. Acta Neurol Scand. 2011 Nov;124(5):343-8. doi: 10.1111/j.1600-0404.2010.01481.x. Epub 2011 Feb 8.
PubMed 21303348
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroinflammatory Response in Patients With ICH and IVH Treated With rtPA
- ClinicalTrials.gov ID
- NCT03452722
- Acronym / sponsor ID
- 13.06.1.1.12
- Keywords
- secondary brain injury, neuroinflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of RijekaUniversity, hospital or other
- Study start
- 1 Jun 2011 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 2 Mar 2018 (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.
This study compares the neuroinflammatory response in patients with hypertensive ICH associated with IVH treated with intraventriculary applied rtPA, and the control group. The inflammatory mediator concentration is analyzed in local cerebrospinal liquor.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Drug: intraventricual recombinant tissue plasminogen activator applicationApplied rtPA |
| Control study | – | –rtPA not applied |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects from 18 to 80 years.
Key inclusion criteria (3 listed)
- Subjects with primary ICH with IVH
- ICH score 2-4, , with origin of the hematoma in the basal ganglia and blood in the third and/or ventricle
- Patient is not considered a surgical candidate by neurosurgery service
Key exclusion criteria (7 listed)
- No history of diseases or drugs that affect the immunological system.
- ICH score 1 and 5
- Current participation in another research drug treatment protocol
- Previously known intracranial arteriovenous malformation or aneurysms
- Intracerebral hematoma considered to be related to trauma
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 |
|---|---|---|
| intraventricual recombinant tissue plasminogen activator application | Drug | Study group |
Primary outcome
Cytokine concentration difference between two groups
Time frame: Samples taken on day 0, day 1, day 3 and day 7.
Cytokine concentration measured from CSL
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 26 Mar 2019.
- Background: PubMed 28081952Hanley DF, Lane K, McBee N, Ziai W, Tuhrim S, Lees KR, Dawson J, Gandhi D, Ullman N, Mould WA, Mayo SW, Mendelow AD, Gregson B, Butcher K, Vespa P, Wright DW, Kase CS, Carhuapoma JR, Keyl PM, Diener-West M, Muschelli J, Betz JF, Thompson CB, Sugar EA, Yenokyan G, Janis S, John S, Harnof S, Lopez GA, Aldrich EF, Harrigan MR, Ansari S, Jallo J, Caron JL, LeDoux D, Adeoye O, Zuccarello M, Adams HP Jr, Rosenblum M, Thompson RE, Awad IA; CLEAR III Investigators. Thrombolytic removal of intraventricular haemorrhage in treatment of severe stroke: results of the randomised, multicentre, multiregion, placebo-controlled CLEAR III trial. Lancet. 2017 Feb 11;389(10069):603-611. doi: 10.1016/S0140-6736(16)32410-2. Epub 2017 Jan 10.
- Background: PubMed 21303348Dunatov S, Antoncic I, Bralic M, Jurjevic A. Intraventricular thrombolysis with rt-PA in patients with intraventricular hemorrhage. Acta Neurol Scand. 2011 Nov;124(5):343-8. doi: 10.1111/j.1600-0404.2010.01481.x. Epub 2011 Feb 8.
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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.
Vlatka Sotosek Tokmadzic, PhD study director
University of Rijeka
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertensive Intracerebral Hemorrhage and Intraventricular Hemorrhage, run by University of Rijeka.
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 3 inclusion and 7 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 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
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.
What does the primary outcome measure?
Cytokine concentration difference between two groups (time frame: Samples taken on day 0, day 1, day 3 and day 7.). 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 NCT03452722, which also lists 2 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 26 Mar 2019.