1. To study safety, feasibility and technical effectiveness of minimally-invasive endoscopy-guided surgery for treatment of supratentorial ICH; 2. To estimate the potential effect of minimally-invasive endoscopy-guided surgery on functional outcome…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
- Nervous system, skull and spine therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome parameters will be safety (death within 24 hours; 7-day
procedure related complications; 7-day mortality, 30 day mortality) and
technical effectiveness (proportional volume reduction; proportion of patients
with clot volume reduction *60% and *80%; proportion of patients with remaining
clot volume *15mL).
Secondary outcome
Secondary parameters will be the effect of surgery on 90 day functional outcome
(modified Rankin Scale) in comparison with the matched control patients with
ICH, on NIHSS at one week and on functional outcome after 180 days.
Background summary
Intracerebral hemorrhage (ICH) accounts for 15-20% of all strokes in Western
Europe, and contributes profoundly to mortality and disability. Thirty day case
fatality is 40% and of those surviving, only few gain independence. Except for
stroke unit care and early blood pressure lowering there is currently no
treatment of proven benefit. Important predictors of poor outcome are
increasing age, decreasing Glasgow Coma Scale score, increasing ICH volume,
presence of intraventricular hemorrhage, and deep or infratentorial location.
In addition, secondary injury, due to development of edema and an inflammatory
response, contribute to disability and death. Surgical treatment, mostly
comprising craniotomy, has so far not been proven effective. In the largest
trials STICH I and II, the median time to treatment was more than 24 hours,
which may be an important explanation for the lack of treatment effect.
We hypothesize that early minimally-invasive endoscopy-guided surgery improves
outcome in patients with spontaneous supratentorial ICH.
Study objective
1. To study safety, feasibility and technical effectiveness of
minimally-invasive endoscopy-guided surgery for treatment of supratentorial
ICH; 2. To estimate the potential effect of minimally-invasive endoscopy-guided
surgery on functional outcome in patients with supratentorial ICH.
Study design
A multicentre, prospective, intervention study, phase II.
Intervention
Minimally-invasive endoscopy-guided surgery within 8 hours of symptom onset, in
addition to standard medical management.
Study burden and risks
Minimally-invasive endoscopy-guided surgery has been shown to carry limited
risks and is of potential benefit to improve outcome. The main risks of surgery
consist of intracranial hemorrhage (rebleeding, subdural hematoma), operation
site infection, and seizures. The burden will consist of performance of 3
additional CT scans within in the first week after ICH and a telephone
interview for outcome assessment after 3 and 6 months. Because patients with
ICH may present with aphasia or decreased consciousness, we will include
competent and non-competent patients; in the latter informed consent will be
obtained from the patients* representatives.
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
1. Age * 18
2. NIHSS * 2
3. Supratentorial ICH confirmed by CT, without a CTA confirmed causative vascular lesion (eg aneurysma, AVM, DAVF, CVST).
4. Minimal lesion size 10 mL
5. Intervention can be started within 8 hours from symptoms onset; or for controls presentation within 8 hours of symptom onset.
6. Written informed consent
Exclusion criteria
1. Pre-stroke disability, which interferes with the assessment of functional outcome at 90 days, i.e. mRS > 2
2. Causative vascular lesion (e.g. aneurysm, AVM, DAVF, CVST) on CTA or other known underlying cause (e.g. tumor, cavernoma)
3. Untreated coagulation abnormalities, including INR>1.3 (point of care measurement allowed) and treatment with oral thrombin or factor X antagonists; patients on vitamin K antagonist can be included after correction of the INR.
4. Current known severe infection for which antibiotic treatment at time of ICH symptom onset
5. Patient moribund (eg. coning, bilateral dilated unresponsive pupils)
6. Pregnancy (note: most patients will be beyond child bearing age; if not a pregnancy test is mandatory).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT03608423 |
| CCMO | NL63100.078.17 |
| OMON | NL-OMON22738 |