Neuroinflammatory Response in Patients With ICH and IVH Treated With rtPA

Brain Injuries Clinical Trial

Official title:

Neuroinflammatory Response in Patients With ICH and IVH Treated With rtPA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03452722
• Other study ID #: 13.06.1.1.12
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Brain Injuries
• Cerebral Hemorrhage
• Hemorrhage
• Hypertensive Intracerebral Hemorrhage
• Intracranial Hemorrhage, Hypertensive
• Intraventricular Hemorrhage

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.