Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2025-12-24 @ 5:50 PM
NCT ID:
NCT01791868
Eligibility Criteria:
Inclusion Criteria:
* Patient older than 18.
* Admitted in a participating ICU for generalized convulsive status epilepticus (GCSE) i.e. with persistent or repeated generalized seizures without regaining consciousness over a period of five minutes. provided that the duration of the treatment prior antiepileptic does not exceed:
* Six hours if GCSE is already controlled at the time of inclusion (= disappearance seizures regardless of the state of consciousness)
* Twenty-four hours if GCSE persisted or is recurrent.
* Written informed consent collected from close relation or a family member of the patient. Otherwise, inclusion according to French Health Code in case of medical emergency. In this case, the written informed consent of patient has to be collected as soon as possible then. in absence of a close of patient, the patient may be still included. the consent of the prosecution will be collected
Exclusion Criteria:
* Other type of status epilepticus (including atypical form) occured before the onset of anti epileptic.
* Female patient of childbearing age ≥ 18 ans et \< 50 ans
* Patient prior treated by depakine in emergency for the GCSE
* The length of stay in hospital expected before the occurrence of GCSE \> 15 days.
* Expected Length of stay in ICU \<12h .
* Hypoxic-ischemic encephalopathy.
* Pregnant women, eclampsia checked by a systematic pregnancy test.
* Pre-existing chronic or acute hepatitis, or Cirrhosis B or C.
* Family history of acute hepatitis, especially drug-related hepatitis
* Other sodium valproate Contraindications : Hypersensitivity to sodium valproate or derivatives, acute or chronic hepatitis; personal or family history of severe hepatitis, in particular drug; hepatic porphyria, mefloquine or hypericum taking.
* life expectancy expected ≤ 3 months.
* Patients already included in another clinical trial on GCSE.
* Non affiliation to a social health care.
* Patients under tutelage.
* Patient has already been included in this protocol and who completed the clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01791868
Study Brief:
Protocol Section:
NCT01791868