Clinical trial NCT01298830: GLP-1 CellBeads® for the Treatment of Stroke Patients With Space-occupying Intracerebral Hemorrhage
Official title: GLP-1 CellBeads® for the Treatment of Stroke Patients With Space-occupying Intracerebral Hemorrhage
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Intracerebral Hemorrhage (ICH)
Lead sponsor: CellMed AG, a subsidiary of BTG plc.
Sponsor class: INDUSTRY
First posted: 2011-02-18
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this study is to assess the safety of GLP-1 CellBeads® in patients with space-occupying intracerebral hemorrhage.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of intracerebral hemorrhage or subarachnoid hemorrhage in conjunction with ICH by cranial computed tomography (CCT) or Magnetic Resonance Tomography (MRT)
* Patients who need by judgement of a clinical neurologist or neurosurgeon surgical removal of the blood clot due to its space-occupying effects
* Age greater or equal 18 years for men
* Age greater or equal 18 years for women if confirmed infertility (e.g. hysterectomy or surgical sterilisation at least 3 months before study start)
* For all other women age greater or equal 50 years with last menstrual bleeding at least one year before study start
* Minimum hematoma diameter of 2 cm as measured in baseline CCT or MRT
* Signed, written informed consent of patient or consent/assertion from the patient's legally acceptable representative/affiliated if the patient is unable to provide informed consent

Exclusion Criteria:

* Participation in any other clinical trial within the past 3 months or ongoing
* Occurrence of inconsistency with initial diagnosis at baseline during surgery of the patient leading to unfulfilled inclusion criterion Hemorrhage secondary to tumour or trauma
* Patients with a cerebellar hemorrhage or extension of a supratentorial hemorrhage into the brainstem
* Patients with severe pre-existing physical or mental disability or severe comorbidity that interferes with the assessment of outcome
* Allergy to contrast media (MRT)
* Acute infection
* Muscular, neurological, or vascular insufficiency of the respective tissue
* Polypropylene incompatibility
* Acute immunosuppressive medication
* Patient after organ transplantation
* Patient with immune depression
* Patients with a high probability of spontaneous recovery or showing rapidly improving signs
* Patients with extensive intracranial hemorrhages or with deep hemispheric localisation of the clots
* Patients whose diagnosis of ICH is uncertain

Primary outcomes:
measure: The objective of this study is to assess the safety of GLP-1 CellBeads® in patients with space-occupying intracerebral hemorrhage
timeFrame: 6 months
Secondary outcomes:
measure: Neurological conditions
timeFrame: 6 months
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Neurochirurgische Klinik und Neurologische Klinik des Universitätsklinikums Heidelberg
state: Baden-Württemberg
city: Erlangen
country: Germany
facility: Neurochirurgische Klinik der Universität Erlangen-Nürnberg
state: Bavaria
city: München
country: Germany
facility: Klinik für Neurochirurgie Klinikum Bogenhausen Akademisches Lehrkrankenhaus der Technischen Universität München
state: Bavaria
city: Hannover
country: Germany
facility: Klinikum Region Hannover Krankenhaus Nordstadt, Klinik für Neurologie
state: Lower Saxony
city: Hannover
country: Germany
facility: International Neuroscience Institute
state: Lower Saxony
city: Hannover
country: Germany
facility: Klinik für Neurochirurgie Medizinische Hochschule Hannover
state: Lower Saxony
Study officials:
affiliation: International Neuroscience Institute Hanover
name: Thomas Brinker, Prof. Dr.med.
role: STUDY_CHAIR
References: