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CompletedNCT03452722Updated Mar 26, 2019

Neuroinflammatory Response in Patients With ICH and IVH Treated With rtPA

An observational study in Hypertensive Intracerebral Hemorrhage, Intraventricular Hemorrhage and Brain Injuries, sponsored by University of Rijeka. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-03-26.

Sponsored by University of Rijeka · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
88
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hypertensive Intracerebral Hemorrhage
  • Intraventricular Hemorrhage
  • Brain Injuries

Keywords

  • secondary brain injury
  • neuroinflammation
03

In context

Intracranial Hemorrhage, Hypertensive

23 studies on the registry are indexed under Intracranial Hemorrhage, Hypertensive; 8 are open to participants now.

Browse Intracranial Hemorrhage, Hypertensive studies →

Lead sponsor

University of Rijeka is the lead sponsor of 21 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All subjects from 18 to 80 years.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
88 participants (actual)
Patient registry
No

Groups and cohorts

  • Study group

    Applied rtPA

    Drug: intraventricual recombinant tissue plasminogen activator application

  • Control study

    rtPA not applied

Interventions

  • Drugintraventricual recombinant tissue plasminogen activator application
06

What researchers measure

Primary outcomes

  1. Cytokine concentration difference between two groups

    Cytokine concentration measured from CSL

    Time frame: Samples taken on day 0, day 1, day 3 and day 7.

07

Study locations

No study locations are listed for this record.

08

References and documents

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 28081952 ↗
  • Dunatov 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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2011 to primary completion in Aug 2017, 74 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 25, 2018
First posted
Mar 2, 2018
StartActual
Jun 1, 2011
Primary completionActual
Aug 1, 2017
CompletionActual
Sep 1, 2018
Last update
Mar 26, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03452722
Lead sponsor
University of Rijeka
Responsible party
Matija Sošić (MD, University of Rijeka) — Principal investigator
First posted
Mar 2, 2018
Start date
Jun 1, 2011
Primary completion
Aug 1, 2017
Completion
Sep 1, 2018
Last update
Mar 26, 2019

Study contacts

Vlatka Sotosek Tokmadzic, PhD
study director · University of Rijeka

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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