Hydrocephalus Clinical Trial
Official title:
Study of Quality of Life After Aneurysmal Subarachnoid Hemorrhage in Patients Aged 70 Years or Older.
In all the Western populations, the annual incidence of subarachnoid hemorrhage (SAH)
increase with age. In patients older than 70 years, the occurrence of SAH exposes them to
high risk of morbidity and a poor quality of life.
In this age bracket, the single randomized which compared endovascular coiling to
microsurgical clipping (ISAT Study) showed that the relative risk of morbidity increased
after coiling. Moreover, some prospectives studies about endovascular coiling described
favorable outcome in 48% to 63% of patients, complete occlusion in 51% to 69% and a
procedural complication rate in 13% to 19%. From prospectives series, the proportion of
favorable outcome after microsurgical clipping was estimated around 66% but the procedural
complications are few reported. The outcome for patients treated conservatively was
catastrophic. Lastly, the hydrocephalus in this age class is common, occurring in 55% of
patients.
The study hypothesis is that, in this age class, no difference exists between the 2
obliteration procedures.
An accurate evaluation of result in term of functional disability, quality of life and
prognosis predictive factors seems a judicious question.
The aim of our study was to determine a significant difference in terms of functional
disability between microsurgical clipping and endovascular coiling in the elderly
population.
Randomized multicenter trial: 2 randomized arms (clipping and coiling) plus 3 observational
prospective arms (clipping, coiling, conservative).
Inclusion time: 48 months. Follow up: 12 months. Monitoring: 6 months. Duration of the
trial: 66 months. Major end point: proportion of patients with unfavourable outcome at 12
months (mRS > 2).
Secondary end point: Quality of life at 12 months (EORTC scale), causes of morbidity (mRS >
2) and mortality, Dysautonomia according to the ADL and IADL scales.
;
Observational Model: Cohort, Time Perspective: Prospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06040697 -
Formative Usability Assessment of Wireless Thermal Anisotropy Devices
|
||
Terminated |
NCT02408757 -
Sonographic Monitoring of Weaning of Cerebrospinal Fluid Drainages
|
||
Terminated |
NCT01863381 -
Comparison of Continuous Non-Invasive and Invasive Intracranial Pressure Measurement
|
N/A | |
Completed |
NCT00652470 -
A Study Comparing Two Treatments for Infants With Hydrocephalus
|
Phase 2 | |
Completed |
NCT00196196 -
A Precision and Accuracy Study of the Codman Valve Position Verification (VPV) System.
|
Phase 3 | |
Terminated |
NCT05501002 -
Pilot Study to Evaluate the CereVasc® eShunt® System in the Treatment of Communicating Hydrocephalus
|
N/A | |
Active, not recruiting |
NCT05068128 -
Combined Flow and Pressure Study of Craniospinal Dynamic
|
||
Completed |
NCT04496414 -
Bactiseal Catheter Safety Registry in China
|
||
Terminated |
NCT02900222 -
Study of Choroid Plexus Cauterization in Patients With Hydrocephalus
|
N/A | |
Recruiting |
NCT04099823 -
MR Evaluation of Cerebrospinal Fluid (CSF) Dynamics
|
N/A | |
Unknown status |
NCT02775136 -
An Evaluation of a Non-invasive Brain Monitor
|
N/A | |
Recruiting |
NCT04758611 -
The ETCHES I Study (Endovascular Treatment of Communicating Hydrocephalus With an Endovascular Shunt)
|
N/A | |
Completed |
NCT03595033 -
Hydrocephalus iPad-App Based Intervention Study
|
N/A | |
Completed |
NCT04207229 -
CERTAS Programmable Valve Registry
|
||
Terminated |
NCT01973764 -
Intraventricular Drain Insertion: Comparison of Ultrasound-guided and Landmark-based Puncture of the Ventricular System
|
N/A | |
Completed |
NCT01976559 -
Comparison of Continuous Noninvasive and Invasive Intracranial Pressure Measurement--Celda Infusion Subprotocol
|
N/A | |
Completed |
NCT02381977 -
Prevalence of Acute Critical Neurological Disease in Children: a Global Epidemiological Assessment
|
N/A | |
Recruiting |
NCT06086561 -
Longitudinal Measurements of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device
|
N/A | |
Recruiting |
NCT05910944 -
European Study of Prodromal iNPH
|
||
Recruiting |
NCT03650101 -
Improving Infant Hydrocephalus Outcomes in Uganda
|