Neuroinflammatory Response in Patients With ICH and IVH Treated With rtPA

NCT ID: NCT03452722

Last Updated: 2019-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

88 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-01

Study Completion Date

2018-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertensive Intracerebral Hemorrhage Intraventricular Hemorrhage Brain Injuries

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study group

Applied rtPA

intraventricual recombinant tissue plasminogen activator application

Intervention Type DRUG

Control study

rtPA not applied

No interventions assigned to this group

Interventions

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intraventricual recombinant tissue plasminogen activator application

Intervention Type DRUG

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Rijeka

OTHER

Sponsor Role lead

Responsible Party

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Matija Sošić

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vlatka Sotosek Tokmadzic, PhD

Role: STUDY_DIRECTOR

University of Rijeka

References

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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.

Reference Type BACKGROUND
PMID: 28081952 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21303348 (View on PubMed)

Other Identifiers

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13.06.1.1.12

Identifier Type: -

Identifier Source: org_study_id

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