Skip to content

Evaluation the serum level of valproic acid in subarachnoid hemorrhage patients

The Evaluation of Valproic acid Pharmacokinetic Key Parameters as a Seizure Prophylactic Agent Following Subarachnoid Hemorrhage

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2013091113572N3
Enrollment
25
Registered
2013-09-22
Start date
2013-09-23
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

subarachnoid hemorrhage. ruptured cerebral aneurysm

Interventions

we consider 1200 mg intravenous sodium valproate as a loading dose that will be diluted in at least 50 ml of normal saline solution and will be infused over 60 minutes with a maximum speed of 20 mg/mi
Prevention

Sponsors

Tehran University Of Medical Sciences
Lead Sponsor
Cobel Darou Company
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Patients with subarachnoid hemorrhage; GCS = 12; Age over 18 Exclusion Criteria: Scr=1.5 mg/dl or urine output>0.5cc/Kg/hr; Plattlet count18; Liver Function Test>3×Normal Range; Mean Arterial Pressure<70; Occurance of seizure during the study; Previous CNS diseases such as Parkinson's, Multiple sclerosis, CNS tumors, Infections involving the brain and CNS; History of using anti-epileptic drugs; Pregnancy; History of urea cycle disorders

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Total serum concentration. Timepoint: after 4 hours, 12 hours, before the third dose ,before the XII dose and before the last dose. Method of measurement: blood sampling from cv-line/GS-MASS.

Secondary

MeasureTime frame
Unbound serum concentration. Timepoint: after 4 hours, 12 hours, before the third dose ,before the XII dose and before the last dose. Method of measurement: formula.;Volume of distribution. Timepoint: after 4 hours, 12 hours, before the third dose ,before the XII dose and before the last dose. Method of measurement: formula.;Clearance. Timepoint: after 4 hours, 12 hours, before the third dose ,before the XII dose and before the last dose. Method of measurement: formula.;2-ene-valproate as a metabolite. Timepoint: after 4 hours, 12 hours, before the third dose ,before the XII dose and before the last dose. Method of measurement: GS-MASS.;4-ene-valproate as a metabolit. Timepoint: after 4 hours, 12 hours, before the third dose ,before the XII dose and before the last dose. Method of measurement: GS-MASS.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Mohammadreza Rouini

Tehran University Of Medical Sciences

rouini@tums.ac.ir+98 21 6695 9056

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026