Neuroinflammatory Response in Patients With ICH and IVH Treated With rtPA

March 24, 2019 updated by: Matija Sošić, University of Rijeka
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

88

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All subjects from 18 to 80 years.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study group
Applied rtPA
Drug: intraventricual recombinant tissue plasminogen activator application
Control study
rtPA not applied

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cytokine concentration difference between two groups
Time Frame: Samples taken on day 0, day 1, day 3 and day 7.
Cytokine concentration measured from CSL
Samples taken on day 0, day 1, day 3 and day 7.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rijeka

Investigators

  • Study Director: Vlatka Sotosek Tokmadzic, PhD, University of Rijeka

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2011

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

February 25, 2018

First Submitted That Met QC Criteria

March 1, 2018

First Posted (Actual)

March 2, 2018

Study Record Updates

Last Update Posted (Actual)

March 26, 2019

Last Update Submitted That Met QC Criteria

March 24, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13.06.1.1.12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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