Neuroinflammatory Response in Patients With ICH and IVH Treated With rtPA

University of Rijeka

Status: Completed

Conditions: Brain Injuries; Hypertensive Intracerebral Hemorrhage; Intraventricular Hemorrhage

Treatments: Drug: intraventricual recombinant tissue plasminogen activator application

Study type: Observational

Funder types: Other

Identifiers

NCT03452722

13.06.1.1.12

Details and patient eligibility

About

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.

Enrollment: 88 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

88 participants in 2 patient groups

Study group

Description:

Applied rtPA

Treatment:

Drug: intraventricual recombinant tissue plasminogen activator application

Control study

Description:

rtPA not applied