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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03452722
Other study ID # 13.06.1.1.12
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2011
Est. completion date September 1, 2018

Study information

Verified date March 2019
Source University of Rijeka
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 88
Est. completion date September 1, 2018
Est. primary completion date August 1, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
intraventricual recombinant tissue plasminogen activator application


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Rijeka

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Cytokine concentration difference between two groups Cytokine concentration measured from CSL Samples taken on day 0, day 1, day 3 and day 7.
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