Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT01830894 |
| Other study ID # |
SHEBA-12-9889-SH-CTIL |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Phase 1/Phase 2
|
| First received |
April 10, 2013 |
| Last updated |
April 10, 2013 |
| Start date |
April 2013 |
| Est. completion date |
June 2014 |
Study information
| Verified date |
March 2013 |
| Source |
Sheba Medical Center |
| Contact |
Sagi Harnof, MD |
| Phone |
+972-52-6666291 |
| Email |
Sagi.HarNof[@]sheba.health.gov.il |
| Is FDA regulated |
No |
| Health authority |
Israel: Ministry of Health |
| Study type |
Interventional
|
Clinical Trial Summary
MRI research Group in the Advanced Technology Center of the Sheba Medical Center has
developed an innovative methodology based on leakage (extravasation) contrast agent that
allows to map the entire brain with high resolution and high sensitivity to check and
describe disorders BBB (blood brain barrier).
The aim of the current study is to evaluate the feasibility of the BBB disruption detection
method to predict delayed peri - hemorrhage edema.
Description:
Research's Protocol:
Evaluation and Correlation between the disruption in blood-brain-barrier and the development
of secondary brain edema associated with brain damage by using MRI in patients with various
types of intra-cranial bleeding .
Research team:
Main (Primary researcher):
Sagi Harnof MD , Neurosurgery department, Sheba medical center, Tel Hashomer
Secondary researchers:
Prof. David Tanne (M.D), Neurology department .
Dr. Yael Mardor (PhD), Advanced technology department.
Dr. Oded Goren (M.D), Neurosurgery department.
Dr. Masswadeh Ahmad (M.D), Neurosurgery Department.
Background :
Spontaneous brain hemorrhage is one of the most difficult issues in strokes concept
regarding underlying pathology, reasons and treatment.
Etiology:
- General prevalence of about approximately 10-15% in all strokes.
- Mortality and morbidity associated with it are the most severe with mortality rates of
up to 50-60%.
There are various pathologies thought to be responsible for bleeding, most commonly known to
be :
hypertension, Angiopathies, amyloidotic or vascular problems and space occupying lesions.
Treatment process that takes place is very limited and most patients are treated only
conservatively.
Cytotoxic brain edema that develops around the bleeding results usually from local cell
damage and local pressure. It usually increases in the first days after bleeding and is
considered to be one of the main causes of deterioration after cerebral hemorrhage .
Sub-dural cerebral hemorrhage is a common disease due to traumatic injury, often with
serious consequences.
Regarding the natural history of subdural bleeding, not only It's believed to be difficult
predicting the bleeding's course, but the risk to induce cerebral edema and later on to
develop into chronic sub Dural bleeding is unpredictable as well .
Nevertheless chronic sub-dural bleeding is one of the most common cases seen in neurosurgery
practice, But worthy to notify that only little is known about the pathogenesis of the
disease, appearance of symptoms , preferable time for drainage and its complications .
Although hasn't been contributing much in clinical evaluation of stoke, MRI has a growing
importance in the field of stroke lately .
In a previous neuro-imaging research that included patients after ischemic stroke it was
shown that with an innovative methodology based on leakage extravasation) contrast agent in
MRI which allows to map the entire brain with high resolution, we can easily evaluate the
sensitivity disorder in BBB .
In 27% of patients who showed no anomalies at BBB in normal MRI, calculated maps with late
leakage showed significant volumes of BBB opening ischemic areas.
MRI research Group in the Advanced Technology Center of the Sheba Medical Center has
developed an innovative methodology based on leakage (extravasation) contrast agent that
allows to map the entire brain with high resolution and high sensitivity to check and
describe disorders BBB.
Data Acquisition:
MRI will be performed using the General Electric (GE) T3.0/1.5 with a standard head coil of
8 channels.
MRI scans will include high-resolution spin-echo T1-weighted MRI , acquired before and at
several time points after injection (1, 12, 20, 23, 30, 70 minutes after injection).
T1-MRI may be done with Echo Time (TE) / Repetition Time (TR) = 22/240 ms, field of view 26
x 19.5 inch, 5/0.5 mm slice thickness and 512x512 - pixels.
To notify : T1-MRI data is acquired simultaneously with any conventional imaging protocol
accepted at Sheba Medical center by routine practice. (Sheba's routine).
Type of study:
A prospective feasibility study performed on a group of patients with cerebral hemorrhage.
The purpose of the study:
1. Assess the ability to characterize quantitatively the BBB disruption around cerebral
hemorrhage.
2. Find a correlation between the degree of BBBD immediately after bleeding and cerebral
edema 3-5 days after bleeding.
3. Search for clinical correlation between the degree of BBBD immediately after the
bleeding and the clinical course that follows it later on.
Methods:
This is a prospective study aimed to test the feasibility of using BBBD protocol in MRI in
order to predict the development of edema and clinical deterioration.
Course of the experiment:
Once the -on call- neurosurgery resident is notified about a patient with spontaneous ICH he
would contact any of the researchers to begin the screening process for participation in the
study. Patients who had undergone intracranial hemorrhage (ICH) that was discovered in the
past twelve hours will undergo a screening process performed by any of the researchers in
order to determine whether or not they meet the inclusion criteria. Such patients may arrive
from the emergency room, intensive care unit or any of the other wards in the hospital.
3. An initial Baseline MRI is to be done:
1. for spontaneous ICH bleeding - within 6-24 hours from the bleeding.
2. for chronic sub dural bleeding - at the time of diagnosis .
3. for acute sub-dural bleeding - within 6-24 hours from the bleeding.
It should be emphasized that the purpose of the MRI is to assess the extent of BBBD and is
intended for research purposes only. This MRI protocol does not allow complete diagnostic
assessment. .
Whether the patient needs an accompanying doctor while in MRI or not, is solely determined
by a researcher, depending on the patient's clinical situation.
4. Clinical follow-up : neurological status, registration of National Institutes of Health
Stroke Scale (NIHSS questionnaire).
a- for spontaneous bleeding - Daily monitoring & registering National Institutes of Health
Stroke Scale (NIHSS) for five consequent days. Additional clinical follow-up will be
performed two weeks later.
b- for chronic or acute sub-dural bleeding follow up visit after 14 days.
5. second MRI which serves as review :
1. for spontaneous intra-cranial bleeding: on the 3rd -5th day after bleeding.
2. For chronic sub Dural bleeding : within two weeks.
3. For acute sub Dural bleeding: within two weeks.
6. Two months later, third MRI will be reviewed for all types of bleeding.
7. Result - Analysis of the outcomes as follows:
Search correlation between BBBD and clinical status. Search BBBD correlation with
hematoma growth.
Search correlation between BBBD and the development of cerebral edema.
Search correlation between BBBD and growth process of Chronic Subdural Hematoma (CSDH)
Search correlation between BBBD and the drainage of CSDH.
Search correlation between BBBD while Acute Subdural Hematoma (ASDH) is converted to
CSDH.
